Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

LEARNING OBJECTIVES

• Evaluate available research establishing the utility of various genomic assays in personalizing adjuvant systemic therapy for hormone receptor (HR)-positive, HER2-negative breast cancer, and identify patients for whom testing would be clinically useful.
• Consider available clinical trial findings with CDK4/6 inhibitors for localized HR-positive, HER2-negative breast cancer, and identify patients for whom adjuvant treatment with one of these agents may be appropriate.
• Review available research documenting the correlation between the presence of various biomarkers (eg, PIK3CA/AKT1/PTEN alterations, ESR1 mutations) and response to specific therapies, and develop optimal testing algorithms for patients with HR-positive metastatic breast cancer (mBC).
• Appraise published efficacy and safety data from randomized clinical trials evaluating CDK4/6 inhibitors for patients with HR-positive mBC to appropriately counsel patients regarding the optimal use of these agents.
• Interrogate published research documenting the efficacy of oral selective estrogen receptor degraders for HR-positive, HER2-negative mBC progressing on endocrine therapy in combination with a CDK4/6 inhibitor in order to optimally integrate these agents into the care of appropriately selected patients.
• Recognize the frequency of PIK3CA/AKT1/PTEN abnormalities in HR-positive mBC, and employ evidence-based approaches designed to target these aberrations for patients with newly diagnosed and relapsed/refractory disease.
• Consider the spectrum, frequency and severity of adverse events associated with various endocrine-based treatment approaches for HR-positive breast cancer, and appreciate strategies to prevent, ameliorate and manage these side effects.
• Recall the design of ongoing clinical trials evaluating novel endocrine-based strategies for HR-positive breast cancer, and appropriately counsel patients about availability and participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 2.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 2.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/SanAntonioHRPosBC25/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Angela DeMichele, MD, MSCE
Mariann T and Robert J MacDonald Professor in Breast Cancer
Director, Clinical/Translational Research, Solid Tumor Oncology, Hematology/Oncology Division
Co-Leader, Breast Cancer Program
Abramson Cancer Center
Co-Director, 2-PREVENT Breast Cancer Translational Center of Excellence
Senior Scholar, Center for Clinical Epidemiology and Biostatistics
Perelman School of Medicine
University of Pennsylvania
Philadelphia, Pennsylvania

Consulting Agreements: Pfizer Inc; Contracted Research: Genentech, a member of the Roche Group, NeoGenomics, Novartis, Pfizer Inc.

Komal Jhaveri, MD, FACP, FASCO
Patricia and James Cayne Chair for Junior Faculty
Associate Attending Physician
Breast Medicine Service and Early Drug Development Service
Section Head, Endocrine Therapy Research Program
Clinical Director, Early Drug Development Service
Department of Medicine
Memorial Sloan Kettering Cancer Center
Associate Professor of Medicine
Weill Cornell College of Medicine
New York, New York

Consultant/Advisory Board Roles: Arvinas, AstraZeneca Pharmaceuticals LP, Bicycle Therapeutics, Blueprint Medicines, Daiichi Sankyo Inc, Eisai Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Halda Therapeutics, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Menarini Group, Merck, Novartis, Olema Oncology, Pfizer Inc, RayzeBio Inc, Scorpion Therapeutics, Stemline Therapeutics Inc, Zymeworks Inc; Research Funding Support to the Institution: AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Eisai Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Novartis, Pfizer Inc, Puma Biotechnology Inc, RayzeBio Inc, Scorpion Therapeutics, Zymeworks Inc.

Erica Mayer, MD, MPH, FASCO
Director of Breast Cancer Clinical Research
Breast Oncology Center
Dana-Farber Cancer Institute
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Aktis Oncology, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Lilly, Novartis.

Hope S Rugo, MD
Director, Women’s Cancers Program
Division Chief, Breast Medical Oncology
Professor, Department of Medical Oncology and Therapeutics Research
City of Hope Comprehensive Cancer Center
Duarte, California
Professor Emeritus, UCSF

Advisory Committees and Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research (Funding to City of Hope): Bicycle Therapeutics, Genentech, a member of the Roche Group, Stemline Therapeutics Inc; Contracted Research (Funding to Prior Institution, UCSF): Ambrx Inc, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc.

Seth Wander, MD, PhD
Director of Precision Medicine
Termeer Center for Targeted Therapies
Director of Translational Research
Breast Oncology Program
Massachusetts General Hospital
Assistant Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Arvinas, AstraZeneca Pharmaceuticals LP, Biotheranostics Inc, A Hologic Company, Biovica International AB, Foundation Medicine, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc, Puma Biotechnology Inc, Regor Therapeutics, Stemline Therapeutics Inc, Veracyte Inc; Contracted Research: Arvinas, Genentech, a member of the Roche Group, Lilly, Menarini Group, Nuvation Bio Inc, Pfizer Inc, Phoenix Molecular Designs, Puma Biotechnology Inc, Regor Therapeutics, Sermonix Pharmaceuticals, Stemline Therapeutics Inc.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from Agendia Inc, Biotheranostics Inc, A Hologic Company, Celcuity, Exact Sciences Corporation, Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics Inc.

Release date: January 2026
Expiration date: January 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr DeMichele

Andre F et al. Biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer: ASCO guideline update. J Clin Oncol 2022;40(16):1816-37. Abstract

Buus R et al. Molecular drivers of Oncotype DX, Prosigna, EndoPredict, and the Breast Cancer Index: A TransATAC study. J Clin Oncol 2021;39(2):126-35. Abstract

Cardoso F et al. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med 2016;375(8):717-29. Abstract

Chen N et al. Impact of anthracyclines in genomic high-risk, node-negative, HR-positive/HER2-negative breast cancer. Ann Oncol 2025;36(11):1356-65. Abstract

Kalinsky K et al. 21-Gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med 2021;385(25):2336-47. Abstract

Nguyen B et al. Comparison of molecular subtyping with BluePrint, MammaPrint, and TargetPrint to local clinical subtyping in breast cancer patients. Ann Surg Oncol 2012;19(10):3257-63. Abstract

Pan H et al. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med 2017;377(19):1836-46. Abstract

Piccart M et al. 70-gene signature as an aid for treatment decisions in early breast cancer: Updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age. Lancet Oncol 2021;22(4):476-88. Abstract

Pusztai L et al. Development and validation of the RSClinN+ tool to predict prognosis and chemotherapy benefit for hormone receptor–positive, node-positive breast cancer. J Clin Oncol 2025;43(8):919-28. Abstract

Sestak I et al. Comparison of the performance of 6 prognostic signatures for estrogen receptor-positive breast cancer: A secondary analysis of a randomized clinical trial. JAMA Oncol 2018;4(4):545-53. Abstract

Sgroi DC et al. Prediction of late disease recurrence and extended adjuvant letrozole benefit by the HOXB13/IL17BR biomarker. J Natl Cancer Inst 2013;105(14):1036-42. Abstract

Sparano JA et al. Trial assigning individualized options for treatment (TAILORx): An update including 12-year event rates. San Antonio Breast Cancer Symposium 2022;Abstract GS1-05.

Sparano JA et al. Development and validation of a tool integrating the 21-gene recurrence score and clinical-pathological features to individualize prognosis and prediction of chemotherapy benefit in early breast cancer. J Clin Oncol 2021;39(6):557-64. Abstract

Sparano JA et al. Clinical outcomes in early breast cancer with a high 21-gene recurrence score of 26 to 100 assigned to adjuvant chemotherapy plus endocrine therapy: A secondary analysis of the TAILORx randomized clinical trial. JAMA Oncol 2020;6(3):367-74. Abstract

Woolpert KM et al. Biomarkers predictive of a response to extended endocrine therapy in breast cancer: A systematic review and meta-analysis. Breast Cancer Res Treat 2024;203(3):407-17. Abstract

Dr Jhaveri

Barrios CH et al. NATALEE update: Safety and treatment (tx) duration of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC). ESMO Breast 2024;Abstract 113MO.

Cortes J et al. monarchE: Subgroup analysis of adjuvant abemaciclib + endocrine therapy for HR+, HER2-, high-risk early breast cancer by nodal status. San Antonio Breast Cancer Symposium 2025;Abstract PS1-08-08.

Crown J et al. Adjuvant ribociclib plus nonsteroidal aromatase inhibitor therapy in patients with HR-positive/HER2-negative early breast cancer: 5-year follow-up of NATALEE efficacy outcomes and updated overall survival. ESMO Open. 2025;10(11). Abstract

Fasching PA et al. Health-related quality of life (HRQoL) in the phase III NATALEE study of adjuvant ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone in patients (pts) with HR+/HER2− early breast cancer (EBC). ESMO Virtual Plenary 2023;Abstract VP3-2023.

Hamilton EP et al. Efficacy and safety results by age in monarchE: Adjuvant abemaciclib combined with endocrine therapy (ET) in patients with HR+, HER2-, node-positive, high-risk early breast cancer (EBC). ASCO 2023;Abstract 501.

Harbeck N et al. Adjuvant abemaciclib plus endocrine therapy for HR+, HER2-, high-risk early breast cancer: Results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. ESMO 2023;Abstract LBA17.

Hortobagyi G et al. Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2− early breast cancer: Final invasive disease–free survival (iDFS) analysis from the NATALEE trial. San Antonio Breast Cancer Symposium 2023;Abstract GS03-03.

Hurvitz S et al. Five-year analysis of distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2− early breast cancer (EBC). San Antonio Breast Cancer Symposium 2025;Abstract PS3-09-08.

Jhaveri K et al. Real-world evidence on risk of recurrence (ROR) in patients (pts) with node-negative (N0) and node-positive HR+/HER2– early breast cancer (EBC) from US electronic health records (EHR). ESMO 2024;Abstract 292P.

Johnston SRD et al. monarchE: Primary overall survival (OS) results of adjuvant abemaciclib + endocrine therapy (ET) for HR+, HER2-, high-risk early breast cancer (EBC). ESMO 2025;Abstract LBA13.

Johnston S et al. Overall survival with abemaciclib in early breast cancer. Ann Oncol 2025;[Online ahead of print]. Abstract

Mayer EL et al. Palbociclib with adjuvant endocrine therapy in early breast cancer: 5-year follow-up analysis of the global multicenter, open-label, randomized phase III PALLAS trial (ABCSG-42/AFT-05/PrE0109/BIG-14-13). Ann Oncol 2025;[Online ahead of print]. Abstract

O’Shaughnessy J et al. Real-world risk of recurrence and treatment outcomes with adjuvant endocrine therapy in patients with stage II-III HR+/HER2- early breast cancer. Breast 2025;81. Abstract

Rastogi P et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: Results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol 2024;42(9):987-93. Abstract

Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol 2022;33(6):616-27. Abstract

Slamon DJ et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med 2024;390(12):1080-91. Abstract

Slamon DJ et al. Rationale and trial design of NATALEE: A phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2- early breast cancer. Ther Adv Med Oncol 2023;15. Abstract

Slamon DJ et al. Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer: Primary results from the phase III NATALEE trial. ASCO 2023;Abstract LBA500.

Tolaney SM et al. Real-world risk of recurrence by nodal status in patients with HR+, HER2-, node-positive, high-risk early breast cancer. NCODA 2025;Abstract.

Tolaney SM et al. Long-term patient-reported outcomes from monarchE: Abemaciclib plus endocrine therapy as adjuvant therapy for HR+, HER2-, node-positive, high-risk, early breast cancer. Eur J Cancer 2024;199. Abstract

Dr Rugo

Bidard FC et al. First-line camizestrant for emerging ESR1-mutated advanced breast cancer. N Engl J Med 2025;393(6):569-80. Abstract

Bidard FC et al. Updated results and an exploratory analysis of ESR1m circulating tumor DNA (ctDNA) dynamics from SERENA-6, a phase 3 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1 mutations (ESR1m) during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2- advanced breast cancer (ABC). San Antonio Breast Cancer Symposium 2025; Abstract RF7-03

de la Haba-Rodriguez J et al. ABIGAIL: Randomized phase II study of abemaciclib plus endocrine therapy (ET) with or without a short course of induction paclitaxel in patients (pts) with previously untreated HR-positive/HER2-negative advanced breast cancer (HR+/HER2- ABC) with aggressive disease criteria. ESMO 2024;Abstract LBA23.

Dieras V et al. Primary results of Ambre, a randomized phase 3 comparing mono-chemotherapy (ct) vs abemaciclib + endocrine therapy (et) in hr+/her2- advanced breast cancer (abc) with high visceral tumor burden. San Antonio Breast Cancer Symposium 2025;Abstract RF7-06.

Goetz MP et al. Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: Final overall survival results of MONARCH 3. Ann Oncol 2024;35(8):718-27. Abstract

Hortobagyi GN et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med 2022;386(10):942-50. Abstract

Jhaveri KL et al. Overall survival with inavolisib in PIK3CA-mutated advanced breast cancer. N Engl J Med 2025;393(2):151-61. Abstract

Loibl S et al. Primary results of the randomised phase III trial comparing first-line ET plus palbociclib vs standard mono-chemotherapy in women with high risk HER2-/HR+ metastatic breast cancer and indication for chemotherapy – PADMA study. San Antonio Breast Cancer Symposium 2024;Abstract LB1-03.

Lu Y-S et al. Final results of RIGHT Choice: Ribociclib plus endocrine therapy versus combination chemotherapy in premenopausal women with clinically aggressive hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. J Clin Oncol 2024;42(23):2812-21. Abstract

Mayer E et al. Patient-reported outcomes (PROs) from the SERENA-6 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1m during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC). ESMO 2025;Abstract 486MO.

Rugo HS et al. Comparative overall survival of CDK4/6 inhibitors plus an aromatase inhibitor in HR+/HER2− metastatic breast cancer in the US real-world setting. ESMO Open 2025;10(1). Abstract

Slamon DJ et al. Overall survival with palbociclib plus letrozole in advanced breast cancer. J Clin Oncol 2024;42(9):994-1000. Abstract

Turner NC et al. Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial. ASCO 2025;Abstract LBA4.

Turner NC et al. INAVO120: Phase III trial final overall survival (OS) analysis of first-line inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC). ASCO 2025;Abstract 1003.

Turner NC et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med 2024;391(17):1584-96. Abstract

Dr Mayer

Hurvitz SA et al. Gedatolisib (geda) + fulvestrant ± palbociclib (palbo) vs fulvestrant in patients (pts) with HR+/ HER2-/PIK3CA wild-type (WT) advanced breast cancer (ABC): First results from VIKTORIA-1. ESMO 2025;Abstract LBA17.

Rosetti S et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast Cancer 2024;10(1):40. Abstract

Turner NC et al. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med 2023;388(22):2058-70. Abstract

Turner NC et al. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): A multicentre, multicohort, phase 2a, platform trial. Lancet Oncol 2020;21(10):1296-308. Abstract

Dr Wander

Bardia A et al. Elacestrant in ER+, HER2- metastatic breast cancer with ESR1-mutated tumors: Subgroup analyses from the phase III EMERALD trial by prior duration of endocrine therapy plus CDK4/6 inhibitor and in clinical subgroups. Clin Cancer Res 2024;30(19):4299-409. Abstract

Bidard F-C et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: Results from the randomized phase III EMERALD trial. J Clin Oncol 2022;40(28):3246-56. Abstract

Brett JO et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res 2021;23(1):85. Abstract

Jeselsohn R et al. ESR1 mutations—A mechanism for acquired endocrine resistance in breast cancer. Nat Rev Clin Oncol 2015;12(10):573-83. Abstract

Jhaveri KL et al. Imlunestrant with or without abemaciclib in advanced breast cancer. N Engl J Med 2025;392(12):1189-202. Abstract

Lloyd MR et al. Clinical and genomic factors associated with elacestrant outcomes in ESR1-mutant metastatic breast cancer. Clin Cancer Res 2025;[Online ahead of print]. Abstract

Mayer E et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial. ESMO 2025;Abstract LBA16.

Rugo HS et al. Real-world outcomes of elacestrant in ER+, HER2−, ESR1-mutant metastatic breast cancer. Clin Cancer Res 2025;[Online ahead of print]. Abstract

Teysir J et al. After a CDK4/6 inhibitor: State of the art in hormone receptor–positive metastatic breast cancer. Am Soc Clin Oncol Educ Book 2025;45(3):e473372. Abstract

Turner NC et al. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): A multicentre, multicohort, phase 2a, platform trial. Lancet Oncol 2020;21(10):1296-308. Abstract

Urso L et al. ESR1 gene mutation in hormone receptor-positive HER2-negative metastatic breast cancer patients: Concordance between tumor tissue and circulating tumor DNA analysis. Front Oncol 2021;11. Abstract

Vasan N et al. Concordance between tissue (tumor DNA) and liquid (ctDNA) biopsy next-generation sequencing (NGS) data in detection of PIK3CA, AKT1, and PTEN alterations in breast cancer: A retrospective analysis. ASCO 2024;Abstract e153033.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

LEARNING OBJECTIVES

• Appreciate the key clinical variables affecting preoperative therapy and the selection of a specific neoadjuvant regimen for patients with HER2-overexpressing localized breast cancer, and integrate this information into treatment decision-making.
• Assess available Phase III data with HER2-directed antibody-drug conjugates as a component of neoadjuvant and adjuvant therapy for patients with high-risk localized disease, and consider the potential clinical role of this novel approach.
• Evaluate published research data to guide the selection and duration of adjuvant and/or extended-adjuvant therapy for patients with HER2-overexpressing localized breast cancer.
• Appraise available research data and clinical and biological factors to guide the selection of first-line therapy for patients with newly diagnosed HER2-positive metastatic breast cancer (mBC).
• Appreciate the key clinical variables affecting the selection and sequencing of therapy for patients with relapsed/refractory HER2-positive mBC, and use this information to personalize treatment recommendations.
• Design an optimal approach to the care of patients with HER2-positive breast cancer and CNS metastases, evaluating the implications of prior treatment exposure, symptomatology, extent of disease and other factors.
• Recognize common and rare side effects associated with approved anti-HER2 agents, and use this information to develop supportive management plans for patients undergoing treatment for HER2-positive breast cancer.
• Assess ongoing clinical research studies evaluating novel agents and treatment strategies under development for HER2-positive breast cancer, and counsel patients regarding the potential benefits of trial participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 2.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 2.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/SanAntonioHER2PosBC25/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Professor Giuseppe Curigliano, MD, PhD
Clinical Director
Division of Early Drug Development for Innovative Therapy
Co-Chair, Cancer Experimental Therapeutics Program
Department of Oncology and Hemato-Oncology
University of Milano
European Institute of Oncology
Milano, Italy

Advisory Committees, Consulting Agreements and Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc; Data and Safety Monitoring Boards/Committees: Roche Laboratories Inc.

Nadia Harbeck, MD, PhD
Breast Center Director
Department of Obstetrics and Gynecology
and Comprehensive Cancer Center Munich
LMU University Hospital
Munich, Germany

Consulting Agreements: Exact Sciences Corporation, Sandoz Inc, a Novartis Division; Data and Safety Monitoring Boards/Committees: Gilead Sciences Inc, IQVIA, Roche Laboratories Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Gilead Sciences Inc, Lilly, Menarini Group, MSD, Novartis, Pfizer Inc, Pierre Fabre, Roche Laboratories Inc, Stemline Therapeutics Inc, Viatris, Zuellig Pharma; Nonrelevant Financial Relationships: West German Study Group (WSG).

Ian E Krop, MD, PhD
Professor of Internal Medicine
Associate Cancer Center Director for Clinical Research
Yale Cancer Center
New Haven, Connecticut

Advisory Committees: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Daiichi Sankyo Inc, EMD Serono Inc, Genentech, a member of the Roche Group, Lilly, Seagen Inc; Consulting Agreements: ALX Oncology, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Halda Therapeutics, Novartis; Contracted Research: Pfizer Inc; Data and Safety Monitoring Boards/Committees: Novartis, Seagen Inc.

Nancy U Lin, MD
Associate Chief, Division of Breast Oncology
Dana-Farber Cancer Institute
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Artera, AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Daiichi Sankyo Inc, Eisai Inc, Janssen Biotech Inc, Menarini Group, Olema Oncology, Seagen Inc, Shorla Oncology, Stemline Therapeutics Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Merck, Olema Oncology, Pfizer Inc, Seagen Inc, Zion Pharmaceuticals; Travel: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Olema Oncology.

Joyce O’Shaughnessy, MD
Celebrating Women Chair in Breast Cancer Research
Baylor University Medical Center
Chair, Breast Disease Committee
Sarah Cannon Research Institute
Dallas, Texas

Advisory Committees and Consulting Agreements: Aadi Bioscience, Agendia Inc, Amgen Inc, Aptitude Health, AstraZeneca Pharmaceuticals LP, BioNTech SE, Bristol Myers Squibb, Daiichi Sankyo Inc, Duality Biologics, Eisai Inc, Ellipses Pharma, Exact Sciences Corporation, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Guardant Health, HiberCell, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Merck, Mersana Therapeutics Inc, Natera Inc, Novartis, Pfizer Inc, Pierre Fabre, Puma Biotechnology Inc, RayzeBio Inc, Roche Laboratories Inc, Sanofi, Seagen Inc, Stemline Therapeutics Inc, Summit Therapeutics, Tempus, TerSera Therapeutics LLC.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, and Puma Biotechnology Inc.

Release date: January 2026
Expiration date: January 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Prof Harbeck

Chan A et al. Final efficacy results of neratinib in HER2-positive hormone receptor-positive early-stage breast cancer from the phase III ExteNET trial. Clin Breast Cancer 2021;21(1):80-91.e7. Abstract

Early Breast Cancer Trialists’ Collaborative group (EBCTCG). Trastuzumab for early-stage, HER2-positive breast cancer: A meta-analysis of 13 864 women in seven randomised trials. Lancet Oncol 2021;22(8):1139-50. Abstract

Geyer CE Jr et al. Survival with trastuzumab emtansine in residual HER2-positive breast cancer. N Engl J Med 2025;392(3):249-57. Abstract

Geyer CE Jr et al. Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary breast cancer (BC) with residual invasive disease after neoadjuvant therapy (tx): Interim analysis of DESTINY-Breast05. ESMO 2025;Abstract LBA1.

Gnant M et al. Efficacy of neratinib in hormone receptor-positive patients who initiated treatment within 1 year of completing trastuzumab-based adjuvant therapy in HER2+ early-stage breast cancer: Subgroup analyses from the phase III ExteNET trial. San Antonio Breast Cancer Symposium 2018;Abstract P2-13-01.

Harbeck N et al. DESTINY-Breast11: Neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer (eBC). ESMO 2025;Abstract 291O.

Harbeck N et al. Neoadjuvant dynamic marker-adjusted personalized therapy comparing trastuzumab-deruxtecan versus pacli-/docetaxel + carboplatin + trastuzumab + pertuzumab in HER2+ early breast cancer: WSG-ADAPT-HER2-IV. ASCO 2024;Abstract TPS631.

Harbeck N et al. A look at current and potential treatment approaches for hormone receptor-positive, HER2-negative early breast cancer. Cancer 2022;128 Suppl 11:2209-23. Abstract

Loibl S et al. Adjuvant pertuzumab or placebo + trastuzumab + chemotherapy (P or Pla + T + CT) in patients (pts) with early HER2-positive operable breast cancer in APHINITY: Final analysis at 11.3 years’ median follow-up. ESMO Breast 2025;Abstract LBA1.

Loibl S et al. Early breast cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol 2024;35(2):159-82. Abstract

Loibl S et al. Phase III study of adjuvant ado-trastuzumab emtansine vs trastuzumab for residual invasive HER2-positive early breast cancer after neoadjuvant chemotherapy and HER2-targeted therapy: KATHERINE final IDFS and updated OS analysis. San Antonio Breast Cancer Symposium 2023;Abstract GS03-12.

Lüftner DI et al. Extended adjuvant neratinib in HER2+/HR+ early breast cancer in clinical routine: Final results from the multi-national, prospective, observational study ELEANOR. ESMO 2025;Abstract 299P.

Tolaney SM et al. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: Final 10-year analysis of the open-label, single-arm, phase 2 APT trial. Lancet Oncol 2023;24(3):273-85. Abstract

van Mackelenbergh MT et al. Pathologic complete response and individual patient prognosis after neoadjuvant chemotherapy plus anti-human epidermal growth factor receptor 2 therapy of human epidermal growth factor receptor 2-positive early breast cancer. J Clin Oncol 2023;41(16):2998-3008. Abstract

Prof Curigliano

Cortés J et al. DEMETHER: A single-arm phase II trial to evaluate the efficacy & safety of subcutaneous pertuzumab & trastuzumab maintenance after induction treatment w/ trastuzumab deruxtecan (T-DXd) for previously untreated HER2-positive advanced breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract P5-03-11.

Dieras V et al. HER2CLIMB-05: A phase 3 study of tucatinib versus placebo in combination with trastuzumab and pertuzumab as first-line maintenance therapy for HER2+ metastatic breast cancer. J Clin Oncol 2025;[Online ahead of print]. Abstract

Gennari A et al. ESMO clinical practice guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol;32(12):1475-1495. Abstract

Hamilton E et al. Her2climb-05: A randomized, double-blind, phase 3 study of tucatinib versus placebo in combination with trastuzumab and pertuzumab as maintenance therapy for her2+ metastatic breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract GS1-01.

Loibl S et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for patients (pts) with HER2+ advanced/metastatic breast cancer (a/mBC): Additional analyses of DESTINY-Breast09 in key subgroups of interest. ESMO 2025;Abstract LBA18.

Swain SM et al. A phase III study of maintenance inavolisib or placebo + pertuzumab + trastuzumab following induction with pertuzumab + trastuzumab + a taxane in patients (pts) with PIK3CA-mutated, HER2-positive advanced breast cancer (HER2+ aBC). ASCO 2024;Abstract TPS1124.

Vaz-Luis IV et al. Health-related quality of life (HRQoL) from the PATINA trial (AFT-38): Impact of adding palbociclib to HER2 and endocrine therapy (ET) after induction in HR+/HER2+ metastatic breast cancer (MBC). ESMO 2025;Abstract 485MO.

Dr Lin

André F et al. A pooled analysis of trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer with brain metastases. Ann Oncol 2024;35(12):1169-80. Abstract

Bartsch R et al. Results of a patient-level pooled analysis of three studies of trastuzumab deruxtecan in HER2-positive breast cancer with active brain metastasis. ESMO Open 2025;10(1):104092. Abstract

Collet L et al. Clinical outcome of patients with isolated central nervous system progression on first-line pertuzumab and trastuzumab treatment for HER2-positive metastatic breast cancer in a real-life cohort. Breast Cancer. 2023;30(2):329-41. Abstract

Dijkers EC et al. Biodistribution of ⁸⁹Zr-trastuzumab and PET imaging of HER2-positive lesions in patients with metastatic breast cancer. Clin Pharmacol Ther 2010;87(5):586-92. Abstract

Harbeck N et al. Trastuzumab deruxtecan in HER2-positive advanced breast cancer with or without brain metastases: A phase 3b/4 trial. Nat Med 2024;30(12):3717-27. Abstract

Hurvitz SA et al. Tucatinib and trastuzumab emtansine for patients with previously treated HER2-positive locally advanced and metastatic breast cancer: Primary analysis of the randomized phase III trial HER2CLIMB-02. Ann Oncol 2025;[Online ahead of print]. Abstract

Hurvitz SA et al. A pooled analysis of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) with brain metastases (BMs) from DESTINY-Breast (DB) -01, -02, and -03. ESMO 2023;Abstract 377O.

Hurvitz SA et al. HER2CLIMB-02: Randomized, double-blind phase 3 trial of tucatinib and trastuzumab emtansine for previously treated HER2-positive metastatic breast cancer. San Antonio Breast Cancer Symposium 2023;Abstract GS01-10.

Kim GM et al. Clinical impact of routine MRI screening for brain metastases in patients with HER2 positive or triple negative metastatic breast cancer. San Antonio Breast Cancer Symposium 2023;Abstract PO2-27-09.

Koide Y et al. Impact of concurrent antibody-drug conjugates and radiotherapy on symptomatic radiation necrosis in breast cancer patients with brain metastases: A multicenter retrospective study. J Neurooncol 2024;168(3):415-23. Abstract

Lin N et al. Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ advanced/metastatic breast cancer (mBC) with or without brain metastases (BM): DESTINYBreast-12 primary results. ESMO 2024;Abstract LBA18.

Lin NU et al. Tucatinib vs placebo, both in combination with trastuzumab and capecitabine, for previously treated ERBB2 (HER2)-positive metastatic breast cancer in patients with brain metastases: Updated exploratory analysis of the HER2CLIMB randomized clinical trial. JAMA Oncol 2023;9(2):197-205. Abstract

Lin NU et al. Updated results of tucatinib vs placebo added to trastuzumab and capecitabine for patients with previously treated HER2-positive metastatic breast cancer with brain metastases (HER2CLIMB). San Antonio Breast Cancer Symposium 2021;Abstract PD4-04.

Lin NU et al. Intracranial efficacy and survival with tucatinib plus trastuzumab and capecitabine for previously treated HER2-positive breast cancer with brain metastases in the HER2CLIMB trial. J Clin Oncol 2020;38(23):2610-9. Abstract

McTyre ER et al. Multi-institutional validation of brain metastasis velocity, a recently defined predictor of outcomes following stereotactic radiosurgery. Radiother Oncol 2020’142:168-74. Abstract

Rashid NS et al. Impact of brain metastasis size at the time of radiotherapy on local control and radiation necrosis. J Neurooncol 2025;173(3):609-17. Abstract

Sammons SL et al. Prevalence by therapy line and incidence of breast cancer brain metastases in 18 075 patients. J Natl Cancer Inst 2025;117(8):1565-72. Abstract

Sperduto PW et al. Survival in patients with brain metastases: Summary report on the updated diagnosis-specific graded prognostic assessment and definition of the eligibility quotient. J Clin Oncol 2020;38(32):3773-84. Abstract

Dr Krop

Cortés J et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: Long-term survival analysis of the DESTINY-Breast03 trial. Nat Med 2024;30(8):2208-15. Abstract

Curigliano G et al. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): Final overall survival analysis. Ann Oncol 2022;33(3):321-9. Abstract

Hurvitz SA et al. Tucatinib and trastuzumab emtansine for patients with previously treated HER2-positive locally advanced and metastatic breast cancer: Primary analysis of the randomized phase III trial HER2CLIMB-02. Ann Oncol 2025:[Online ahead of print]. Abstract

Jhaveri K et al. Neratinib + fulvestrant + trastuzumab for HR-positive, HER2-negative, HER2-mutant metastatic breast cancer: Outcomes and biomarker analysis from the SUMMIT trial. Ann Oncol 2023;34(10):885-98. Abstract

Murthy RK et al. Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer. N Engl J Med 2020;382(7):597-609. Abstract

Murthy RK et al. Tucatinib vs placebo, both combined with capecitabine and trastuzumab, for patients with pretreated HER2-positive metastatic breast cancer with and without brain metastases (HER2CLIMB). San Antonio Breast Cancer Symposium 2019;Abstract GS1-01.

Nordstrom JL et al. Anti-tumor activity and toxicokinetics analysis of MGAH22, an anti-HER2 monoclonal antibody with enhanced Fcγ receptor binding properties. Breast Cancer Res 2011;13(6):R123. Abstract

Rugo HS et al. Efficacy of margetuximab vs trastuzumab in patients with pretreated ERBB2-positive advanced breast cancer: A phase 3 randomized clinical trial. JAMA Oncol 2021;7(4):573-84. Abstract

Saura C et al. Trastuzumab deruxtecan in previously treated patients with HER2-positive metastatic breast cancer: Updated survival results from a phase II trial (DESTINY-Breast01). Ann Oncol 2024;35(3):302-7. Abstract

Saura C et al. Neratinib plus capecitabine versus lapatinib plus capecitabine in HER2-positive metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: Phase III NALA trial. J Clin Oncol 2020;38(27):3138-49. Abstract

Song E et al. SHR-A1811 versus pyrotinib plus capecitabine in human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (BC): A multicenter, open-label, randomized, phase III study (HORIZON-Breast01). ESMO 2025;Abstract LBA19.

Yao H et al. Safety, efficacy, and pharmacokinetics of SHR-A1811, a human epidermal growth factor receptor 2-directed antibody-drug conjugate, in human epidermal growth factor receptor 2-expressing or mutated advanced solid tumors: A global phase I trial. J Clin Oncol 2024;42(29):3453-65. Abstract

Weisser NE et al. An anti-HER2 biparatopic antibody that induces unique HER2 clustering and complement-dependent cytotoxicity. Nat Commun 2023;14(1):1394. Abstract

Dr O’Shaughnessy

Bardia A et al. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med 2024;391(22):2110-22. Abstract

Canellas A et al. Trastuzumab deruxctecan (T-DXd) associated interstitial lung disease (ILD) in a large real-world French cohort of patients with HER2-driven breast cancer and other malignancies. ESMO 2024;Abstract 346MO.

Curigliano G et al. Trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow metastatic breast cancer (mBC) with prior endocrine therapy (ET): Primary results from DESTINY-Breast06 (DB-06). ASCO 2024;Abstract LBA1000.

Lebow ES et al. Symptomatic necrosis with antibody-drug conjugates and concurrent stereotactic radiotherapy for brain metastases. JAMA Oncol 2023;9(12):1729-33. Abstract

Modi S et al. Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Updated survival results of the randomized, phase III DESTINY-Breast04 study. ESMO 2023;Abstract 376MO.

Moy B et al. Association between treatment duration and overall survival in early-stage HER2+ breast cancer patients receiving extended adjuvant therapy with neratinib in the ExteNET trial. ASCO 2021;Abstract 540.

Natsuhara KH et al. Treatment rechallenge after trastuzumab-deruxtecan–related interstitial lung disease: A multi-institution cohort study. ASCO 2025;Abstract 1015.

Navari RM et al. Olanzapine for the prevention of chemotherapy-induced nausea and vomiting. N Engl J Med 2016;375(2):134-42. Abstract

Powell CA et al. Pooled analysis of drug-related interstitial lung disease and/or pneumonitis in nine trastuzumab deruxtecan monotherapy studies. ESMO Open 2022;7(4):100554. Abstract

Rugo HS et al. Pooled analysis of trastuzumab deruxtecan (T-DXd) retreatment (RTx) after recovery from grade (Gr) 1 interstitial lung disease/pneumonitis (ILD). ESMO Breast 2024;Abstract 267MO.

Rugo HS et al. Real-world perspectives and practices for pneumonitis/interstitial lung disease associated with trastuzumab deruxtecan use in human epidermal growth factor receptor 2-expressing metastatic breast cancer. JCO Oncol Pract 2023;19(8):539-46. Abstract

Rugo HS et al. Trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): A detailed safety analysis of the randomized, phase III DESTINY-Breast04 trial. ESMO Breast 2023;Abstract 185O.

Rugo HS et al. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open 2022;7(4):100553. Abstract

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of colorectal cancer.

LEARNING OBJECTIVES

• Understand the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in colorectal cancer, and recognize the rationale for its use in detecting molecular residual disease (MRD).
• Outline optimal approaches for ctDNA-based assessment of MRD, and determine the appropriate timing of and platform for ctDNA testing for patients with colorectal cancer.
• Appreciate published datasets documenting the clinical utility of ctDNA testing in risk stratification, surveillance and therapeutic decision-making for patients with colorectal cancer, and consider the current and future role of this strategy in personalizing treatment recommendations.
• Recall ongoing studies examining the role of ctDNA-based assays in clinical decision-making for colorectal cancer, and appropriately refer patients for study participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 0.5 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/5MJC/ctDNAAssays/GI/1/Video and evaluation ResearchToPractice.com/5MJC/ctDNAAssays25/GI/1/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Scott Kopetz, MD, PhD
Professor
Deputy Chair for Translational Research
Department of Gastrointestinal Medical Oncology
Associate Vice President for Translational Integration
The University of Texas MD Anderson Cancer Center
Houston, Texas

Consulting Agreements: Agenus Inc, Amgen Inc, AmMax Bio, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Carina Biotech, Clasp Therapeutics, Cytovation ASA, Dewpoint Therapeutics, Frontier Medicines, Genentech, a member of the Roche Group, Harbinger Health, Ikena Oncology, Kestrel Therapeutics, Leap Therapeutics Inc, Marengo Therapeutics, Merck, Mirati Therapeutics Inc, Pfizer Inc, Replimune, Revolution Medicines, Roche Laboratories Inc, SageMedic Corporation, Servier Pharmaceuticals LLC, Sibylla Biotech, T-Cypher Bio, Tachyon Therapeutics, Tempus, Xaira Therapeutics, Zentalis Pharmaceuticals; Contracted Research: Amgen Inc, BioMed Valley Discoveries, Boehringer Ingelheim Pharmaceuticals Inc, BridgeBio, Bristol Myers Squibb, Cardiff Oncology, Daiichi Sankyo Inc, EMD Serono Inc, Frontier Medicines, Genentech, a member of the Roche Group, Guardant Health, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Pfizer Inc, Zentalis Pharmaceuticals.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.

These activities are supported by an educational grant from Natera Inc.

Release date: January 2026
Expiration date: January 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dasari A et al. Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA): NRG-GI008. ASCO 2025;Abstract TPS3644.

Dasari NA et al. Clinical utility of including circulating tumor DNA (ctDNA) monitoring in standard of care colorectal cancer (CRC) surveillance. ESMO GI 2025;Abstract 2O.

Kataoka K et al. Survival benefit of adjuvant chemotherapy based on molecular residual disease detection in resected colorectal liver metastases: Subgroup analysis from CIRCULATE-Japan GALAXY. Ann Oncol 2024;35(11):1015-25. Abstract

Nakamura Y et al. ctDNA-based molecular residual disease and survival in resectable colorectal cancer. Nat Med 2024;30(11):3272-83.Abstract

Osterlund E et al. Circulating tumour DNA (ctDNA) clearance and correlation with outcome in the INTERCEPT colorectal cancer (CRC) study. ESMO 2025;Abstract 732MO.

Shah PK et al. Circulating tumor DNA for detection of molecular residual disease (MRD) in patients (pts) with stage II/III colorectal cancer (CRC): Final analysis of the BESPOKE CRC sub-cohort. Gastrointestinal Cancers Symposium 2025;Abstract 15.

Tie J et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: Overall survival and updated 5-year results from the randomized DYNAMIC trial. ASCO 2024;Abstract 108.

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of colorectal cancer.

LEARNING OBJECTIVES

• Understand the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in colorectal cancer, and recognize the rationale for its use in detecting molecular residual disease (MRD).
• Outline optimal approaches for ctDNA-based assessment of MRD, and determine the appropriate timing of and platform for ctDNA testing for patients with colorectal cancer.
• Appreciate published datasets documenting the clinical utility of ctDNA testing in risk stratification, surveillance and therapeutic decision-making for patients with colorectal cancer, and consider the current and future role of this strategy in personalizing treatment recommendations.
• Recall ongoing studies examining the role of ctDNA-based assays in clinical decision-making for colorectal cancer, and appropriately refer patients for study participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 0.75 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/5MJC2025/ctDNAAssays/GI/2/Video and evaluation ResearchToPractice.com/5MJC2025/ctDNAAssays/GI/2/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Scott Kopetz, MD, PhD
Professor
Deputy Chair for Translational Research
Department of Gastrointestinal Medical Oncology
Associate Vice President for Translational Integration
The University of Texas MD Anderson Cancer Center
Houston, Texas

Consulting Agreements: Agenus Inc, Amgen Inc, AmMax Bio, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Carina Biotech, Clasp Therapeutics, Cytovation ASA, Dewpoint Therapeutics, Frontier Medicines, Genentech, a member of the Roche Group, Harbinger Health, Ikena Oncology, Kestrel Therapeutics, Leap Therapeutics Inc, Marengo Therapeutics, Merck, Mirati Therapeutics Inc, Pfizer Inc, Replimune, Revolution Medicines, Roche Laboratories Inc, SageMedic Corporation, Servier Pharmaceuticals LLC, Sibylla Biotech, T-Cypher Bio, Tachyon Therapeutics, Tempus, Xaira Therapeutics, Zentalis Pharmaceuticals; Contracted Research: Amgen Inc, BioMed Valley Discoveries, Boehringer Ingelheim Pharmaceuticals Inc, BridgeBio, Bristol Myers Squibb, Cardiff Oncology, Daiichi Sankyo Inc, EMD Serono Inc, Frontier Medicines, Genentech, a member of the Roche Group, Guardant Health, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Pfizer Inc, Zentalis Pharmaceuticals.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.

These activities are supported by an educational grant from Natera Inc.

Release date: January 2026
Expiration date: January 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Bando H et al. A randomized, double-blind, phase III study comparing trifluridine/tipiracil (FTD/TPI) versus placebo in patients with molecular residual disease following curative resection of colorectal cancer (CRC): The ALTAIR study. Gastrointestinal Cancers Symposium 2025;Abstract LBA22.

Bekaii-Saab T. Discussant of LBA9. ESMO 2025.

Cohen SA et al. Real-world monitoring of ctDNA reliably predicts cancer recurrence and treatment efficacy in patients with resected stages I-III colon cancer. Ann Surg 2025;[Online ahead of print]. Abstract

LaPelusa M et al. Long-term efficacy of pembrolizumab and the clinical utility of ctDNA in locally advanced dMMR/MSI-H solid tumors. Nat Commun 2025;16(1):4514. Abstract

Nakamura Y et al. Clinical validation of a methylation-based, tissue-free colorectal cancer test for the detection of molecular residual disease by ctDNA. ESMO GI 2025;Abstract 93P.

Nowak JA et al. Prognostic and predictive role of ctDNA in stage III colon cancer treated with celecoxib: Findings from CALGB (Alliance)/SWOG 80702. Gastrointestinal Cancers Symposium 2025;Abstract LBA14.

Tie J et al. Circulating tumor DNA-guided adjuvant therapy in locally advanced colon cancer: The randomized phase 2/3 DYNAMIC-III trial. Nat Med 2025;[Online ahead of print]. Abstract

Tie J et al. ctDNA-guided adjuvant chemotherapy de-escalation in stage III colon cancer: Primary analysis of the ctDNA-negative cohort from the randomized AGITG DYNAMIC-III trial (intergroup study of AGITG and CCTG). ESMO 2025;Abstract LBA9.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

LEARNING OBJECTIVES

• Appreciate the pathophysiology, incidence and severity of class-effect and agent-specific toxicities associated with FDA-approved antibody-drug conjugates (ADCs) in the care of patients with metastatic breast cancer (mBC).
• Understand the frequency and severity of gastrointestinal side effects of ADCs, and educate patients about to commence treatment with these agents regarding the potential development of these adverse events, how to prevent them and what to do if they occur.
• Implement a plan of care to monitor for, recognize and manage interstitial lung disease or pneumonitis in patients receiving treatment with ADCs.
• Recall strategies to identify, manage and mitigate other toxicities associated with ADCs commonly used in the care of patients with mBC, such as fatigue, neutropenia, stomatitis and ocular toxicities, and use this information to appropriately intervene when side effects are suspected or diagnosed.
• Appraise the role of multidisciplinary specialists in the diagnosis and management of toxicities associated with ADCs commonly used in the care of patients with mBC, and effectively collaborate to offer best-practice care.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology..

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/PP2025/ADCToxmBC/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Lisa A Carey, MD, ScM, FASCO
L Richardson and Marilyn Jacobs Preyer Distinguished Professor for Breast Cancer Research
University of North Carolina at Chapel Hill
Deputy Director for Clinical Sciences
Lineberger Comprehensive Cancer Center
Chief Clinical Research Officer, Clinical Research Partners
UNC Health
Chapel Hill, North Carolina

No relevant financial relationships to disclose.

Rita Nanda, MD
Director, Breast Oncology
Associate Professor of Medicine
Section of Hematology/Oncology
The University of Chicago
Chicago, Illinois

Advisory Committees: Arvinas, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Exact Sciences Corporation, GE Healthcare, Gilead Sciences Inc, Guardant Health, Lilly, Mabwell Therapeutics Inc, Merck, Moderna, Novartis, Pfizer Inc, Stemline Therapeutics Inc, Summit Therapeutics; Contracted Research: Arvinas, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Corcept Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, GSK, Merck, Novartis, OBI Pharma Inc, Pfizer Inc, Relay Therapeutics, Sun Pharma Advanced Research Company, Taiho Oncology Inc.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.

These activities are supported by an educational grant from Gilead Sciences Inc.

Release date: December 2025
Expiration date: December 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Cortés JC et al. Primary results from ASCENT-03: A randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (chemo) in patients (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are unable to receive PD-(L)1 inhibitors (PD-[L]1i). ESMO 2025;Abstract LBA20.

de Azambuja E et al. Patient-reported outcomes (PROs) with sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in patients (pts) with ppreviously untreated PD-L1+ meatstatic triple-negative breast cancer (mTNBC) in the phase III ASCENT-04/KEYNOTE-D19 study. ESMO 2025;Abstract LBA22.

Dent RA et al. First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Primary results from the randomised, phase III TROPION-Breast02 trial. ESMO 2025;Abstract LBA21.

Fan Y et al. Sacituzumab tirumotecan (sac-TMT) vs investigator’s choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): Results from the randomized, multicenter phase 3 OptiTROP-Breast02 study. ESMO 2025;Abstract LBA23.

Geyer CE et al. Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary breast cancer (BC) with residual invasive disease after neoadjuvant therapy (tx): Interim analysis of DESTINY-Breast05. ESMO 2025;Abstract LBA1.

Hamilton E et al. Her2climb-05: A randomized, double-blind, phase 3 study of tucatinib versus placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract GS1-01.

Harbeck N et al. DESTINY-Breast11: Neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer (eBC). ESMO 2025;Abstract 2910O.

Harbeck N et al. Efficacy and safety of neoadjuvant trastuzumab deruxtecan versus standard of care chemotherapy plus trastuzumab plus pertuzumab in HER2+ early breast cancer: WSG-ADAPT-HER2-IV. San Antonio Breast Cancer Symposium 2025;Abstract GS1-02.

Hurvitz S et al. Tucatinib and trastuzumab emtansine for patients with previously treated HER2-positive locally advanced and metastatic breast cancer: Primary analysis of the randomized phase III trial HER2CLIMB-02. Ann Oncol 2025;[Online ahead of print]. Abstract

Jhaveri K et al. Sacituzumab govitecan vs chemotherapy as first therapy after endocrine therapy in HR+/HER2−(IHC 0, 1+, 2+/ISH−) metastatic breast cancer: Primary results from ASCENT-07. San Antonio Breast Cancer Symposium 2025;Abstract GS1-10.

Loibl S et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for patients with HER2+ advanced/metastatic breast cancer: Additional analyses of DESTINY-Breast09 in keynote subgroups of interest. ESMO 2025;Abstract LBA18.

Pérez García JM et al. Prevention of sacituzumab govitecan-related neutropenia and diarrhea in patients with HER2-negative advanced breast cancer (PRIMED): An open-label, single-arm, phase 2 trial. ASCO 2024;Abstract 1101.

Tolaney SM et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. ASCO 2025;Abstract LBA109.

Tolaney SM et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINYBreast09. ASCO 2025;Abstract LBA1008.

Faculty

TARGET AUDIENCE
This program is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of urothelial bladder cancer and prostate cancer.

LEARNING OBJECTIVES

• Evaluate the published research supporting the FDA approvals of secondary hormonal agents for nonmetastatic prostate cancer, including for patients who experience biochemical recurrence after local therapy, and apply this information in the discussion of nonresearch treatment options.
• Appreciate the biological rationale for targeting the PI3K/AKT/mTOR pathway in prostate cancer, and evaluate available data with novel AKT inhibitors in combination with hormonal therapy for patients with metastatic hormone-sensitive prostate cancer and PTEN deficiency.
• Assess the available research database with PARP inhibitors in combination with androgen receptor pathway inhibitors for patients with metastatic prostate cancer harboring a homologous recombination repair gene alteration, and discern how to optimally incorporate these agents into clinical management algorithms.
• Review available Phase III data documenting the efficacy of various forms of radioligand therapy for patients with metastatic prostate cancer, and consider the current and potential clinical role of these strategies.
• Understand the biological rationale for combining anti-PD-1/PD-L1 antibodies with bacillus Calmette-Guerin for patients with non-muscle-invasive bladder cancer, and discuss available data with and the potential role of this novel approach.
• Analyze the scientific justification for the use of perioperative immune checkpoint inhibitor-based therapy for patients with muscle-invasive bladder cancer, and evaluate available data documenting the efficacy and safety of this therapeutic strategy.
• Reflect on pivotal clinical trial findings with novel compounds with unique mechanisms of action, such as antibody-drug conjugates, for metastatic urothelial bladder cancer (UBC), and identify patients for whom treatment with these approaches would be appropriate.
• Recall the design of ongoing clinical trials evaluating other novel agents and strategies for prostate cancer and UBC, and appropriately counsel patients about availability and participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/PostESMO25/Bladder/Prostate/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Terence Friedlander, MD
Professor of Medicine and Robert and Virginia O’Reilly Family Endowed Chair
Chief, Division of Hematology/Oncology
Zuckerberg San Francisco General Hospital
Helen Diller Family Comprehensive Cancer Center
University of California, San Francisco
San Francisco, California

Advisory Committees: Aadi Bioscience, AbbVie Inc, Adaptimmune, Aktis Oncology, Astellas, Bicycle Therapeutics, Bristol Myers Squibb, Gilead Sciences Inc, Merck, Pfizer Inc, Samsung Bioepis; Consulting Agreements: Astellas, EMD Serono Inc, Genentech, a member of the Roche Group; Contracted Research: AbbVie Inc, Bicycle Therapeutics, Flare Therapeutics, Genentech, a member of the Roche Group, Johnson & Johnson, Pfizer Inc.

Rana R McKay, MD
Professor of Medicine and Urology
Associate Director, Clinical Research
Co-Lead, Genitourinary Program
Moores Cancer Center
University of California San Diego
San Diego, California

Advisor/Consultant: Ambrx, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Blue Earth Diagnostics, Bristol Myers Squibb, Calithera Biosciences, Caris Life Sciences, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Exelixis Inc, Johnson & Johnson, Lilly, Merck, Myovant Sciences, Neomorph, Novartis, Pfizer Inc, Sanofi, Seagen Inc, Sorrento Therapeutics, Telix Pharmaceuticals Limited, Tempus; Institutional Research Funding: Artera, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Exelixis Inc, Oncternal Therapeutics, Tempus.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP and Natera Inc.

Release date: December 2025
Expiration date: December 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Aggarwal R et al. Final results from PRESTO: A phase III open-label study of combined androgen blockade in patients (pts) with high-risk biochemically relapsed prostate cancer (BRPC) (AFT-19). ESMO 2025;Abstract LBA88.

Azad AA et al. First interim efficacy analysis of the phase I/II PETRANHA trial of saruparib + androgen receptor pathway inhibitors (ARPI) in patients (pts) with metastatic prostate cancer (mPC). ESMO 2025;Abstract 2384MO.

Carles Galceran J et al. Time to response with talazoparib (TALA) + enzalutamide (ENZA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) in TALAPRO-2. ESMO 2025;Abstract 2428P.

Cho KS et al. Lymphovascular invasion of transurethral resection specimens as predictor as progression and metastasis in patients with newly diagnosed T1 bladder urothelial cancer. J Urol 2009;182(6):2625-30. Abstract

De Santis M et al. Durvalumab (D) in combination with bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. ESMO 2025;Abstract LBA108.

Fizazi K et al. A phase III study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. ESMO 2025;Abstract 2383O.

Fizazi K et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol 2025;[Online ahead of print]. Abstract

Galsky MD et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. ESMO 2025;Abstract 3068O.

Makker V et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) part 1 final analysis. ESMO 2025;Abstract 957P.

Necchi A et al. Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results. ESMO 2025;Abstract LBA112.

Nguyen PL et al. Randomised phase III trial of androgen deprivation therapy (ADT) with radiation therapy with or without enzalutamide for high risk, clinically localised prostate cancer: ENZARAD (ANZUP 1303). ESMO 2025;Abstract LBA86.

Powles T et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med 2024;391(19):1773-86. Abstract

Powles TB et al. IMvigor011: A phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer. ESMO 2025;Abstract LBA8.

Powles TB et al. A randomised phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024;Abstract LBA5.

Rha SY et al. Datopotamab deruxtecan (Dato-DXd) + rilvegostomig (rilve) in patients (pts) with locally advanced or metastatic urothelial cancer (a/mUC): Results from the phase II TROPION-PanTumor03 study. ESMO 2025;Abstract 3072MO.

Sheng X et al. Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression. ESMO 2025;Abstract LBA7.

Shore ND et al. EMBARK: Overall survival with enzalutamide in biochemically recurrent prostate cancer. ESMO 2025;Abstract LBA87.

Tagawa ST et al. Phase III trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition). ESMO 2025;Abstract LBA6.

van der Heijden MS et al. Health-related quality of life (HRQoL) outcomes from the NIAGARA trial of perioperative durvalumab (D) plus neoadjuvant chemotherapy (NAC) in muscle-invasive bladder cancer (MIBC). ESMO 2025;Abstract 3069MO.

Vulsteke C et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. ESMO 2025;Abstract LBA2.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematology-oncology fellows, surgeons and other healthcare providers involved in the treatment of gastrointestinal cancers.

LEARNING OBJECTIVES

• Understand validated biomarkers of response, such as HER2 overexpression, PD-L1 combined positive score and claudin 18.2 (CLDN18.2) expression, found in patients with gastric, gastroesophageal junction (GEJ) and esophageal cancers, and consider the implications for molecular testing and clinical care.
• Describe the published research data with anti-PD-1/PD-L1 antibodies alone or in combination with other systemic therapies in the management metastatic gastric, GEJ and esophageal cancers, and optimally integrate these strategies into nonresearch treatment algorithms.
• Assess available data with monoclonal antibody therapy directed at CLDN18.2 in combination with chemotherapy as first-line treatment for patients with HER2-negative, CLDN18.2-positive gastric or GEJ cancer, and optimally incorporate this approach into management algorithms.
• Review published research findings with HER2-targeted therapies for patients with HER2-positive gastroesophageal cancers, and assess the current and potential roles of various agents and regimens in the care of appropriately selected patients.
• Review the rationale for, available data with and ongoing research studies evaluating novel agents and strategies for patients with gastroesophageal cancers in preparation for potential clinical availability or to enhance trial participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/PPGI2025/AdvancedGE/2/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Yelena Y Janjigian, MD
Professor and Chief Attending, Gastrointestinal Oncology Service
Memorial Sloan Kettering Cancer Center
New York, New York

Advisory Committees: AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals Inc, Daiichi Sankyo Inc; Consulting Agreements: AbbVie Inc, AlphaSights, Arcus Biosciences, ARS Pharmaceuticals, AskGene Pharma, Astellas, AstraZeneca Pharmaceuticals LP, Basilea Pharmaceutica Ltd, Bayer HealthCare Pharmaceuticals, BeOne, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Cencora, Daiichi Sankyo Inc, eChina Health, Eisai Inc, Geneos Therapeutics, Gilead Sciences Inc, GSK, Guardant Health, HC Wainwright & Co, Health Advances, Imugene, Inspirna, Lilly, Lynx Health, Merck, Merck Serono, Mersana Therapeutics Inc, PeerMD, Pfizer Inc, Sanofi, Seagen Inc, Suzhou Liangyihui Network Technology Co Ltd, Zymeworks Inc; Contracted Research: Arcus Biosciences, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Genentech, a member of the Roche Group, Inspirna, Lilly, Merck, Transcenta; Stock Options — Private Companies: Inspirna; Nonrelevant Financial Relationships: Clinical Care Options, Cycle for Survival, Debbie’s Dream Foundation, ED Medresources Inc, Fred’s Team, HMP, i3Health, Imedex, Mashup Media LLC, Master Clinician Alliance, MJH Life Sciences, National Cancer Institute, OncoDaily (stock options), Paradigm Medical Communications, PeerView, Physician Education Resource (PER), Stand Up 2 Cancer, Talem Health, TotalCME, US Department of Defense, Veda Life Sciences Inc (stock options), WebMD.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, and Merck.

Release date: December 2025
Expiration date: December 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Chao J et al. Assessment of pembrolizumab therapy for the treatment of microsatellite instability-high gastric or gastroesophageal junction cancer among patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 clinical trials. JAMA Oncol 2021;7(6):895-902. Abstract

Chau I et al. Nivolumab (NIVO) plus chemotherapy (chemo) or ipilimumab (IPI) vs chemo as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): 5-year follow-up from CheckMate 648. ESMO 2025;Abstract 2106P.

Elimova E et al. Long-term outcomes and overall survival (OS) for zanidatamab + chemotherapy in HER2-positive (HER2+) advanced or metastatic gastroesophageal adenocarcinoma (mGEA): 4-year follow-up of a phase 2 trial. ASCO 2025;Abstract 4013.

Elimova E et al. Zanidatamab plus chemotherapy as first-line treatment for patients with HER2-positive advanced gastro-oesophageal adenocarcinoma: Primary results of a multicentre, single-arm, phase 2 study. Lancet Oncol 2025;26(7):847-59. Abstract

Elimova E et al. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4-year follow-up of CheckMate 649. ASCO 2024;Abstract 4040.

Goekkurt E et al. Pembrolizumab and trastuzumab in combination with FLOT in the preoperative treatment of HER2-positive localized esophagogastric adenocarcinoma – Interim analysis of the phase II PHERFLOT/IKF053 trial. ESMO 2025;Abstract 2095MO.

Janjigian YY et al. CLARITY-Gastric 01: A randomized phase 3 study of AZD0901, a Claudin18.2 (CLDN18.2)-targeted antibody-drug conjugate, in second- or later-line (2L+) advanced gastric or gastroesophageal junction cancer (GC/GEJC). Gastrointestinal Cancers Symposium 2025;Abstract TPS507.

Janjigian YY et al. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 5-year (y) follow-up results from CheckMate 649. Gastrointestinal Cancers Symposium 2025;Abstract 398.

Janjigian YY et al. Updated results from the trastuzumab deruxtecan (T-DXd) 5.4 mg/kg triplet combination of DESTINY-Gastric03 (DG-03): First-line (1L) T-DXd with fluoropyrimidine (FP) and pembrolizumab in advanced/metastatic HER2-positive (HER2+) esophageal adenocarcinoma, gastric cancer (GC), or gastroesophageal junction adenocarcinoma (GEJA). Gastrointestinal Cancers Symposium 2025;Abstract 448.

Lordick F et al. Updated efficacy and safety results from phase III GLOW study evaluating zolbetuximab + CAPOX as first-line (1L) treatment for patients with claudin-18 isoform 2-positive (CLDN18.2+), HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. ESMO 2024;Abstract 134MO.

Rha S et al. Lenvatinib plus pembrolizumab and chemotherapy versus chemotherapy in advanced, metastatic gastroesophageal adenocarcinoma: The phase 3, randomized LEAP-015 study. ASCO 2025;Abstract 4001.

Rha SY et al. Final overall survival for the phase III, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. ESMO Asia 2024;Abstract 128MO.

Shitara K et al. Lenvatinib plus pembrolizumab and chemotherapy versus chemotherapy in advanced metastatic gastroesophageal adenocarcinoma: The phase III, randomized LEAP-015 study. J Clin Oncol 2025;43(22):2502-14. Abstract

Shitara K et al. Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) + paclitaxel (PTX) in second-line treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA): Primary analysis of the randomized, phase 3 DESTINY-Gastric04 study. N Engl J Med 2025;393(4):336-48. Abstract

Shitara K et al. CLARITY-Gastric 01: A randomised phase III study of AZD0901, a claudin18.2 (CLDN18.2)-targeted antibody-drug conjugate, in second- or later-line (2L+) advanced gastric or gastroesophageal junction cancer (GC/GEJC). ESMO GI 2024;Abstract 495TiP.

Shitara K et al. Final overall survival results from phase 3 SPOTLIGHT study evaluating zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients (pts) with claudin 18 isoform 2 (CLDN18.2)+, HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. ASCO 2024;Abstract 4036.

Shitara K et al. TroFuse-015: A phase III study of trophoblast antigen 2 (TROP2)–directed antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) vs treatment of physician’s choice (TPC) for previously treated metastatic gastroesophageal adenocarcinoma (GEA). ESMO 2024;Abstract 263TiP.

Tabernero J et al. Final overall survival and the association of pathological outcomes with event-free survival in MATTERHORN: A randomised, phase 3 study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel in resectable gastric/gastroesophageal junction adenocarcinoma. ESMO 2025;Abstract LBA81.

Xu J et al. Anbenitamab in combination with chemotherapy for previously treated HER2 positive gastric or gastroesophageal junction carcinomas (GC/GEJC): Interim analysis of KC-WISE. ESMO 2025;Abstract LBA78.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, surgeons, radiation oncologists, pharmacists, nurse practitioners, clinical nurse specialists and other healthcare professionals involved in the treatment of cancer.

LEARNING OBJECTIVES

• Appraise the clinical relevance of recent pivotal cancer research published in peer-reviewed journals or presented at major oncology conferences.
• Recall ongoing clinical trials in select hematologic cancers and solid tumors, and as appropriate, refer patients for participation.
• Incorporate individual preferences, tumor biomarkers and other treatment-related factors in personalizing therapy for patients with cancer.
• Educate patients with hematologic cancers or solid tumors about the benefits and risks of novel therapeutic agents and strategies.
• Apply an awareness of new datasets and the perspectives of tumor-specific clinical investigators to refine or validate treatment algorithms.
• Evaluate the mechanisms of action, tolerability and efficacy of promising investigational agents, and consider the implications for clinical practice. 

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 4.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 4.5 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology and hematology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology. 

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/AON25/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Justin F Gainor, MD
Director, Center for Thoracic Cancers Program
Director of Targeted Immunotherapy in the Henri and Belinda Termeer Center for Targeted Therapies
Massachusetts General Hospital
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Advisory Committees: Amgen Inc, ARS Pharmaceuticals, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Genentech, a member of the Roche Group, Gilead Sciences Inc, ITeos Therapeutics, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Mariana Oncology, Merck, Merus, Mirati Therapeutics Inc, Moderna, Novartis, Novocure Inc, Nuvalent, Pfizer Inc, Sanofi, Takeda Pharmaceuticals USA Inc; Consulting Agreements: Merck, Novartis, Pfizer Inc, Takeda Pharmaceuticals USA Inc; Contracted Research: Adaptimmune, ALX Oncology, AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Bristol Myers Squibb, Genentech, a member of the Roche Group, Jounce Therapeutics, Merck, Moderna, NextPoint Therapeutics, Novartis, Palleon Pharmaceuticals; Nonrelevant Financial Relationships: AI Proteins.

Gottfried E Konecny, MD
Professor of Medicine and Ob/Gyn
Director, Medical Gynecologic Oncology
Division of Hematology and Oncology
David Geffen School of Medicine
University of California, Los Angeles
Los Angeles, California

No relevant financial relationships to disclose.

Corey J Langer, MD
Director of Thoracic Oncology
Abramson Cancer Center
Professor of Medicine
Perelman School of Medicine
University of Pennsylvania
Philadelphia, Pennsylvania

Advisory Committees: Amgen Inc, Merck; Consulting Agreements: Aptitude Health, Boehringer Ingelheim Pharmaceuticals Inc, Catalyst Pharmaceuticals Inc, EMD Serono Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Merck, Pfizer Inc, Regeneron Pharmaceuticals Inc; Contracted Research (Institutional Support for Clinical Research): Amgen Inc, FUJIFILM Pharmaceuticals USA Inc, Novocure Inc; Data and Safety Monitoring Boards/Committees: Incyte Corporation, Summit Therapeutics; Nonrelevant Financial Relationships: Valor (VA).

Kerry A Rogers, MD
Associate Professor
Division of Hematology
The Ohio State University
Columbus, Ohio

Advisory Committees: Genentech, a member of the Roche Group, Janssen Biotech Inc; Consulting Agreements: AbbVie Inc, Alpine Immune Sciences, AstraZeneca Pharmaceuticals LP, BeOne, Genentech, a member of the Roche Group, Lilly; Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Lilly; Data and Safety Monitoring Boards/Committees:AstraZeneca Pharmaceuticals LP.

Manish A Shah, MD
Professor of Medicine
Bartlett Family Professor of Gastrointestinal Oncology
Chief, Solid Tumor Oncology
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York

No relevant financial relationships to disclose.

Misty Dawn Shields, MD, PhD
Assistant Professor of Clinical Medicine
Indiana University School of Medicine
Adjunct Assistant Professor of Medical and Molecular Genetics
Associate Member, Experimental and Developmental Therapeutics
Department of Medicine, Division of Hematology/Oncology, Thoracic Oncology
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana

Steering Committees: AstraZeneca Pharmaceuticals LP.

MODERATOR
Stephen “Fred” Divers, MD 
Chief Medical Officer
American Oncology Network
Hot Springs, Arkansas

Advisory Committees: Daiichi Sankyo Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AbbVie Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeOne, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Merck, and Nuvalent.

Release date: December 2025
Expiration date: December 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Lung Cancer

Dr Gainor

Ahn M-J et al. Efficacy and safety of datopotamab deruxtecan (Dato-DXd) in patients (pts) with previously-treated EGFR-mutated advanced non-small cell lung cancer (NSCLC): A pooled analysis of TROPION-Lung01 and TROPION-Lung05. ESMO Asia 2024;Abstract LBA7.

Camidge DR et al. Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer. N Engl J Med2018;379(21):2027-39. Abstract

Drilon AE et al. Pivotal ARROS-1 efficacy and safety data: Zidesamtinib in TKI pre-treated patients with advanced/metastatic ROS1+ NSCLC. World Conference on Lung Cancer 2025;Abstract PL02.15.

Drilon AE et al. Phase I/II ALKOVE-1 study of NVL-655 in ALK-positive (ALK+) solid tumours. ESMO 2024;Abstract 1253O.

Drilon AE et al. Repotrectinib in ROS1 fusion-positive non-small-cell lung cancer. N Engl J Med2024;390(2):118-31. Abstract

Drilon AE et al. Long-term efficacy and safety of entrectinib in ROS1 fusion-positive NSCLC. JTO Clin Res Rep 2022;3(6). Abstract

Goto K et al. Trastuzumab deruxtecan in patients with HER2-mutant metastatic non-small-cell lung cancer: Primary results from the randomized, phase II DESTINY-Lung02 trial. J Clin Oncol2023;41(31):4852-63. Abstract

Jänne PA et al. Survival with osimertinib plus chemotherapy in EGFR-mutated advanced NSCLC. N Engl J Med 2025;[Online ahead of print]. Abstract

Le X et al. Sevabertinib (BAY 2927088) in advanced HER2-mutant non-small cell lung cancer (NSCLC): Results from the SOHO-01 study. ESMO 2025;Abstract LBA75.

Leighl NB et al. Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory epidermal growth factor receptor-mutated non-small cell lung cancer: Primary results from the phase III PALOMA-3 study. J Clin Oncol 2024;42(30):3593-605. Abstract

Mok TSK et al. Final overall survival (OS) and safety analysis of the phase III ALEX study of alectinib vs crizotinib in patients with previously untreated, advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC). ESMO 2025;Abstract LBA73. 

Pérol M et al. Taletrectinib in ROS1+ non-small cell lung cancer: TRUST. J Clin Oncol 2025;43(16):1920-9. Abstract

Peters S et al. Alectinib versus crizotinib in previously untreated ALK-positive advanced non-small cell lung cancer: Final overall survival analysis of the Phase III ALEX study. Ann Oncol 2025;[Online ahead of print]. Abstract

Peters S et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med 2017;377(9):829-38. Abstract

Piotrowska Z et al. Zipalertinib in NSCLC patients (pts) with EGFR exon 20 insertion (Ex20Ins) mutations who received prior amivantamab. World Conference on Lung Cancer 2025;Abstract MA08.02.

Popat S et al. Zongertinib as first-line treatment in patients with advanced HER2-mutant NSCLC: Beamion LUNG 1. ESMO 2025;Abstract LBA74.

Popat S et al. Amivantamab plus chemotherapy vs chemotherapy in EGFR-mutated, advanced non-small cell lung cancer after disease progression on osimertinib: Second interim overall survival from MARIPOSA-2. ESMO 2024;Abstract LBA54.

Ramalingam SS et al. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. N Engl J Med 2020;382(1):41-50. Abstract

Smit EF et al. Trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer (DESTINY-Lung01): Primary results of the HER2-overexpressing cohorts from a single-arm, phase 2 trial. Lancet Oncol 2024;25(4):439-54. Abstract

Solomon BJ et al. Lorlatinib vs crizotinib in treatment-naïve patients with advanced ALK+ non-small cell lung cancer: 5-year progression-free survival and safety from the CROWN study. ASCO 2024;Abstract LBA8503.

Waliany S, Lin JJ. Taletrectinib: TRUST in the continued evolution of treatments for ROS1 fusion-positive lung cancer. J Clin Oncol 2024;42(22):2622-7. Abstract

Wang M et al. A multinational phase 2 randomized pivotal study of sunvozertinib in pretreated NSCLC with EGFR exon 20 insertion mutations. World Conference on Lung Cancer 2025;Abstract MA08.01. 

Yang JC-H et al. Overall survival with amivantamab-lazertinib in EGFR-mutated advanced NSCLC. N Engl J Med 2025;393(17):1681-93. Abstract

Yang JC-H et al. Phase II dose-randomized study of sunvozertinib in platinum-pretreated non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations (WU-KONG1B). J Clin Oncol 2025;43(29):3198-208. Abstract

Yu HA et al. Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab. ASCO 2025;Abstract 8503.

Zhou C et al. Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions. N Engl J Med2023;389(22):2039-51. Abstract

Dr Langer

Ahn M-J et al. Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: Primary analysis of the phase 2 IDeate-Lung01 study. World Conference on Lung Cancer 2025;Abstract OA06.03.

Ahn M-J et al. Tarlatamab for patients with previously treated small-cell lung cancer. N Engl J Med2023;389(22):2063-75. Abstract

Boiarsky D et al. Molecular markers of metastatic disease in KRAS-mutant lung adenocarcinoma. Ann Oncol 2023;34(7):589-604. Abstract

Horn L et al. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N Engl J Med 2018;379(23):2220-9. Abstract

Hummel H-D et al. Tarlatamab in previously treated small cell lung cancer (SCLC): DeLLphi-300 phase I study long-term outcomes and intracranial activity. ELCC 2024;Abstract 195MO.

Lu S et al. Phase III study of ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (HARMONi-6). ESMO 2025;Abstract LBA4.

Liu SV et al. Five-year survival in patients with ES-SCLC treated with atezolizumab in IMpower133: Imbrella a extension study results. World Conference on Lung Cancer 2023;Abstract OA01.04.

Paz-Ares L et al. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): A randomised, multicentre, open-label, phase 3 trial. Lancet 2025;405(10495):2129-43. Abstract

Paz-Ares L et al. Tarlatamab for patients (pts) with previously treated small cell lung cancer (SCLC): Primary analysis of the phase II DeLLphi-301 study. ESMO 2023;Abstract LBA92.

Paz-Ares L et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN.ESMO Open 2022;7(2). Abstract

Paz-Ares L et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): A randomised, controlled, open-label, phase 3 trial. Lancet 2019;394(10212):1929-39. Abstract

Peressini M et al. Spatially preserved multi-region transcriptomic subtyping and biomarkers of chemoimmunotherapy outcome in extensive-stage small cell lung cancer. Clin Cancer Res2024;30(14):3036-49. Abstract

Peters S et al. Long-term survival outcomes with first-line nivolumab plus ipilimumab-based treatment in patients with metastatic NSCLC and tumor programmed death-ligand 1 lower than 1%: A pooled analysis. J Thorac Oncol 2025;20(1):94-108. Abstract

Peters S et al. Association between KRAS/STK11/KEAP1 mutations and outcomes in POSEIDON: Durvalumab ± tremelimumab + chemotherapy in mNSCLC. World Conference on Lung Cancer 2022;Abstract OA15.04.

Ricciuti B et al. Diminished efficacy of programmed death-(ligand)1 inhibition in STK11- and KEAP1-mutant lung adenocarcinoma is affected by KRAS mutation status. J Thorac Oncol 2022;17(3):399-410. Abstract

Rudin CM et al. Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of ph3 DeLLphi-304. ASCO 2025;Abstract LBA8008.

Rudin CM et al. Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer (ES-SCLC): Interim analysis of Ideate-lung01. World Conference on Lung Cancer 2024;Abstract OA04.03.

Rudin CM et al. Pembrolizumab or placebo plus etoposide and platinum as first-line therapy for extensive-stage small-cell lung cancer: Randomized, double-blind, phase III KEYNOTE-604 study. J Clin Oncol 2020;38(21):2369-79. Abstract

Senan S et al. Durvalumab (D) as consolidation therapy in limited-stage SCLC (LS-SCLC): Outcomes by prior concurrent chemoradiotherapy (cCRT) regimen and prophylactic cranial irradiation (PCI) use in the ADRIATIC trial. ESMO 2024;Abstract LBA81.

Skoulidis F et al. CTLA4 blockade abrogates KEAP1/STK11-related resistance to PD-(L)1 inhibitors.Nature 2024;635(8038):462-71. Abstract

Skoulidis F et al. TRITON: Phase 3b study of tremelimumab (T) + durvalumab (D) vs pembrolizumab (P), in combination with chemotherapy (CT), in non-squamous (NSQ) metastatic NSCLC (mNSCLC) with STK11 and/or KEAP1 and/or KRAS mutations. ASCO 2024;Abstract TPS8655.

Spigel DR et al. ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC). ASCO 2024;Abstract LBA5.

Xiong A et al. Ivonescimab versus pembrolizumab for PD-L1-positive NSCLC: A subgroup analysis of HARMONi-2 by tumor histology. World Conference on Lung Cancer 2025;Abstract P1.11.83.

Zhou C et al. Safety and efficacy of QLC5508 in previously treated patients with small cell lung cancer: Updated data from a phase 1 study. World Conference on Lung Cancer 2025;Abstract OA06.02.

Zhou C et al. Phase 3 study of ivonescimab (AK112) vs. pembrolizumab as first-line treatment for PD-L1-positive advanced NSCLC: Primary analysis of HARMONi-2. World Conference on Lung Cancer 2024;Abstract PL02.04.

Dr Shields

Besse B et al. Adjuvant pembrolizumab versus placebo for early-stage NSCLC after resection and optional chemotherapy: Updated results from PEARLS/KEYNOTE-091. ESMO Immuno-Oncology Congress 2023;Abstract 120MO.

Cascone T et al. Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: Updated survival and biomarker analyses from CheckMate 77T. ASCO 2025;Abstract LBA8010.

Felip E et al. Five-year survival outcomes with atezolizumab after chemotherapy in resected stage IB-IIIA non-small cell lung cancer (IMpower010): An open-label, randomized, phase III trial. J Clin Oncol 2025;43(21):2343-9. Abstract

Forde PM et al. Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816. ASCO 2025;Abstract LBA8000.

Heymach JV et al. Perioperative durvalumab for resectable NSCLC (R-NSCLC): Updated outcomes from the phase 3 AEGEAN trial. World Conference on Lung Cancer 2024;Abstract OA13.03.

Wakelee HA et al. Perioperative pembrolizumab in early-stage non-small-cell lung cancer (NSCLC): 5-year follow-up from KEYNOTE-671. ESMO 2025;Abstract LBA67.

Wakelee HA et al. IMpower010: Final disease-free survival (DFS) and second overall survival (OS) interim results after ≥5 years of follow up of a phase III study of adjuvant atezolizumab vs best supportive care in resected stage IB-IIIA non-small cell lung cancer (NSCLC). ASCO 2024;Abstract LBA8035. 

Chronic Lymphocytic Leukemia

Dr Rogers 

Al-Sawaf O et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized phase 3 CLL14 study. Blood 2024;144(18):1924-35. Abstract

Brown JR et al. Fixed-duration acalabrutinib combinations in untreated chronic lymphocytic leukemia.N Engl J Med 2025;392(8):748-62. Abstract 

Brown JR et al. Fixed-duration acalabrutinib plus venetoclax with or without obinutuzumab versus chemoimmunotherapy for first-line treatment of chronic lymphocytic leukemia: Interim analysis of the multicenter, open-label, randomized, phase 3 AMPLIFY trial. ASH 2024;Abstract 1009. 

Burger JR et al. Final analysis of the RESONATE-2 study: Up to 10 years of follow-up of first-line ibrutinib treatment in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. EHA 2024;Abstract P670. 

Fürstenau M et al. First-line venetoclax combinations versus chemoimmunotherapy in fit patients with chronic lymphocytic leukaemia (GAIA/CLL13): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 2024;25(6):744-59. Abstract

Ghia P et al. First-line ibrutinib treatment in patients with chronic lymphocytic leukemia is associated with overall survival rates similar to those of an age-matched general population: A pooled post hoc analysis. Hemasphere 2024;8(5):e74. Abstract

Patten PEM et al. CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naive CLL.ASH 2024;Abstract 3257.1. 

Scarfo L et al. Updated efficacy and safety of the Bruton tyrosine kinase (BTK) degrader BGB-16673 in patients (PTS) with relapsed or refractory (R/R) CLL/SLL: Results from the ongoing phase (PH) 1 CADANCE-101 study. EHA 2025;Abstract S158. 

Shadman M et al. Combination of zanubrutinib (zanu) + venetoclax (ven) for treatment-naive (TN) CLL/SLL: Results in SEQUOIA arm D. ASCO 2025;Abstract 7009. 

Sharman JP et al. Phase III trial of pirtobrutinib versus idelalisib/rituximab or bendamustine/rituximab in covalent Bruton tyrosine kinase inhibitor-pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (BRUIN CLL-321). J Clin Oncol 2025;43(22):2538-49. Abstract

Sharman JP et al. BRUIN CLL-321: Randomized phase III trial of pirtobrutinib versus idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in BTK inhibitor pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma. ASH 2024;Abstract 886. 

Sharman JP et al. Acalabrutinib ± obinutuzumab vs obinutuzumab + chlorambucil in treatment-naive chronic lymphocytic leukemia: 6-year follow-up of Elevate-TN. ASH 2023;Abstract 636. 

Soumerai JD et al. Multicenter phase II trial of zanubrutinib, obinutuzumab, and venetoclax (BOVen) in treatment-naïve chronic lymphocytic leukemia: 5-year follow up, retreatment outcomes, and impact of MRD kinetics (ΔMRD400). ASH 2024;Abstract 1867. 

Soumerai JD et al. Sonrotoclax and zanubrutinib as frontline treatment for CLL demonstrates high MRD clearance rates with good tolerability: Data from an ongoing phase 1/1b study BGB-11417-101. ASH 2024;Abstract 1012. 

Tam CSL et al. SEQUOIA 5-year follow-up in arm C: Frontline zanubrutinib monotherapy in patients with del(17p) and treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). ASCO 2025;Abstract 7011. 

Woyach J et al. Pirtobrutinib vs ibrutinib in treatment-naïve and relapsed/refractory CLL/SLL: Results from the first randomized phase III study comparing a non-covalent and covalent BTK inhibitor. ASH 2025;Abstract abs25-2587. 

Ovarian Cancer

Dr Konecny 

Alvarez Secord A et al. Final analysis of the single-arm phase II PICCOLO trial of mirvetuximab soravtansine-gynx (MIRV) in folate receptor alpha (FRα)-positive, third-line and later (3L+), recurrent platinum-sensitive ovarian cancer (PSOC). ESMO Gynaecological Cancers 2025;Abstract 76MO. 

Colombo N et al. Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind phase III ENGOT-ov65/KEYNOTE-B96 study. ESMO 2025;Abstract LBA3. 

González-Martin A et al. Final overall survival (OS) in patients (pts) with newly diagnosed advanced ovarian cancer (aOC) treated with niraparib (nir) first-line (1L) maintenance: Results from PRIMA/ENGOT-OV26/GOG-3012. ESMO 2024;Abstract LBA29. 

Makker V et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) part 1 final analysis. ESMO 2025;Abstract 957P. 

Meric-Bernstam F et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: Primary analysis from the DESTINY-PanTumor02 (DP-02) study. ESMO 2023;Abstract LBA34. 

Moore KN et al. Second progression-free survival (PFS2) and subsequent treatment in patients (pts) with folate receptor alpha (FR⍺)-positive platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs investigator’s choice chemotherapy (ICC): Phase III MIRASOL trial. ESMO 2025;Abstract 1068P. 

Olawaiye A et al. ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). ASCO 2025;Abstract LBA5507. 

Ray-Coquard IL et al. Raludotatug deruxtecan (R-DXd) in patients (pts) with platinum-resistant ovarian cancer (PROC): Primary analysis of the phase II dose-optimization part of REJOICE-Ovarian01. ESMO 2025;Abstract LBA42. 

Van Gorp T et al. Final overall survival analysis among patients with folate receptor alpha-positive, platinum-resistant ovarian cancer treated with mirvetuximab soravtansine versus investigator’s choice chemotherapy in phase II MIRASOL (GOG-3045/ENGOT-ov55) study. SGO 2025;Abstract 939696. 

Gastroesophageal Cancers

Dr Shah

Baek JH et al. Clinical implications of Claudin18.2 expression in patients with gastric cancer.Anticancer Res 2019;39(12):6973-9. Abstract

Elimova E et al. Long-term outcomes and overall survival (OS) for zanidatamab + chemotherapy in HER2-positive (HER2+) advanced or metastatic gastroesophageal adenocarcinoma (mGEA): 4-year follow-up of a phase 2 trial. ASCO 2025;Abstract 4013. 

Janjigian YY et al. Final overall survival for the phase III, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. ESMO 2024;Abstract 1400O. 

Janjigian YY et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): A randomised, open-label, phase 3 trial. Lancet 2021;398(10294):27-40. Abstract

Kuwata T. Molecular classification and intratumoral heterogeneity of gastric adenocarcinoma. Pathol Int 2024;74(6):301-16. Abstract

Martins F et al. Adverse effects of immune-checkpoint inhibitors: epidemiology, management and surveillance. Nat Rev Clin Oncol 2019;16(9):563-80. Abstract

Moehler MH et al. Rationale 305: Phase 3 study of tislelizumab plus chemotherapy vs placebo plus chemotherapy as first-line treatment (1L) of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). Gastrointestinal Cancers Symposium 2023;Abstract 286. 

Rha SY et al. Bemarituzumab (BEMA) plus chemotherapy for advanced or metastatic FGFR2b-overexpressing gastric or gastroesophageal junction cancer (G/GEJC): FORTITUDE-101 phase III study results. ESMO 2025;Abstract LBA10. 

Rha SY et al. Prevalence of FGFR2b protein overexpression in advanced gastric cancers during prescreening for the phase III FORTITUDE-101 trial. JCO Precis Oncol 2025;9. Abstract

Rha SY et al. Pembrolizumab (pembro) plus chemotherapy (chemo) as first-line therapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer: Phase III KEYNOTE-859 study.ESMO Virtual Plenary 2023;Abstract VP1-2023. 

Sato S et al. Clinical characterization of FGFR2b expression in patients with advanced gastric or gastroesophageal junction adenocarcinoma. ESMO Open 2025;10(7). Abstract

Shitara K et al. Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) + paclitaxel (PTX) in second-line treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA): Primary analysis of the randomized, phase 3 DESTINY-Gastric04 study. ASCO 2025;Abstract LBA4002. 

Shitara K et al. Zolbetuximab in gastric or gastroesophageal junction adenocarcinoma. N Engl J Med2024;391(12):1159-62. Abstract

Wainberg ZA et al. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): A randomised, double-blind, placebo-controlled, phase 2 study.Lancet Oncol 2022;23(11):1430-40. Abstract

Wainberg ZA et al. Randomized double-blind placebo-controlled phase 2 study of bemarituzumab combined with modified FOLFOX6 (mFOLFOX6) in first-line (1L) treatment of advanced gastric/gastroesophageal junction adenocarcinoma (FIGHT). Gastrointestinal Cancers Symposium 2021;Abstract 160. 

Yashiro M et al. Clinical difference between fibroblast growth factor receptor 2 subclass, type IIIb and type IIIc, in gastric cancer. Sci Rep 2021;11(1):4698. Abstract

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, surgeons, radiation oncologists, pharmacists, nurse practitioners, clinical nurse specialists and other healthcare professionals involved in the treatment of cancer.

LEARNING OBJECTIVES

• Appraise the clinical relevance of recent pivotal cancer research published in peer-reviewed journals or presented at major oncology conferences.
• Recall ongoing clinical trials in select hematologic cancers and solid tumors, and as appropriate, refer patients for participation.
• Incorporate individual preferences, tumor biomarkers and other treatment-related factors in personalizing therapy for patients with cancer.
• Educate patients with hematologic cancers or solid tumors about the benefits and risks of novel therapeutic agents and strategies.
• Apply an awareness of new datasets and the perspectives of tumor-specific clinical investigators to refine or validate treatment algorithms.
• Evaluate the mechanisms of action, tolerability and efficacy of promising investigational agents, and consider the implications for clinical practice. 

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 4.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 4.5 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology and hematology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology. 

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/AON25/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Justin F Gainor, MD
Director, Center for Thoracic Cancers Program
Director of Targeted Immunotherapy in the Henri and Belinda Termeer Center for Targeted Therapies
Massachusetts General Hospital
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Advisory Committees: Amgen Inc, ARS Pharmaceuticals, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Genentech, a member of the Roche Group, Gilead Sciences Inc, ITeos Therapeutics, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Mariana Oncology, Merck, Merus, Mirati Therapeutics Inc, Moderna, Novartis, Novocure Inc, Nuvalent, Pfizer Inc, Sanofi, Takeda Pharmaceuticals USA Inc; Consulting Agreements: Merck, Novartis, Pfizer Inc, Takeda Pharmaceuticals USA Inc; Contracted Research: Adaptimmune, ALX Oncology, AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Bristol Myers Squibb, Genentech, a member of the Roche Group, Jounce Therapeutics, Merck, Moderna, NextPoint Therapeutics, Novartis, Palleon Pharmaceuticals; Nonrelevant Financial Relationships: AI Proteins.

Gottfried E Konecny, MD
Professor of Medicine and Ob/Gyn
Director, Medical Gynecologic Oncology
Division of Hematology and Oncology
David Geffen School of Medicine
University of California, Los Angeles
Los Angeles, California

No relevant conflicts of interest to disclose.

Corey J Langer, MD
Director of Thoracic Oncology
Abramson Cancer Center
Professor of Medicine
Perelman School of Medicine
University of Pennsylvania
Philadelphia, Pennsylvania

Advisory Committees: Amgen Inc, Merck; Consulting Agreements: Aptitude Health, Boehringer Ingelheim Pharmaceuticals Inc, Catalyst Pharmaceuticals Inc, EMD Serono Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Merck, Pfizer Inc, Regeneron Pharmaceuticals Inc; Contracted Research (Institutional Support for Clinical Research): Amgen Inc, FUJIFILM Pharmaceuticals USA Inc, Novocure Inc; Data and Safety Monitoring Boards/Committees: Incyte Corporation, Summit Therapeutics; Nonrelevant Financial Relationships: Valor (VA).

Kerry A Rogers, MD
Associate Professor
Division of Hematology
The Ohio State University
Columbus, Ohio

Advisory Committees: Genentech, a member of the Roche Group, Janssen Biotech Inc; Consulting Agreements: AbbVie Inc, Alpine Immune Sciences, AstraZeneca Pharmaceuticals LP, BeOne, Genentech, a member of the Roche Group, Lilly; Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Lilly; Data and Safety Monitoring Boards/Committees:AstraZeneca Pharmaceuticals LP.

Manish A Shah, MD
Professor of Medicine
Bartlett Family Professor of Gastrointestinal Oncology
Chief, Solid Tumor Oncology
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York

No relevant conflicts of interest to disclose.

Misty Dawn Shields, MD, PhD
Assistant Professor of Clinical Medicine
Indiana University School of Medicine
Adjunct Assistant Professor of Medical and Molecular Genetics
Associate Member, Experimental and Developmental Therapeutics
Department of Medicine, Division of Hematology/Oncology, Thoracic Oncology
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana

Steering Committees: AstraZeneca Pharmaceuticals LP.

MODERATOR
Stephen “Fred” Divers, MD 
Chief Medical Officer
American Oncology Network
Hot Springs, Arkansas

Advisory Committees: Daiichi Sankyo Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AbbVie Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeOne, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Merck, and Nuvalent.

Release date: December 2025
Expiration date: December 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Lung Cancer

Dr Gainor

Ahn M-J et al. Efficacy and safety of datopotamab deruxtecan (Dato-DXd) in patients (pts) with previously-treated EGFR-mutated advanced non-small cell lung cancer (NSCLC): A pooled analysis of TROPION-Lung01 and TROPION-Lung05. ESMO Asia 2024;Abstract LBA7.

Camidge DR et al. Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer. N Engl J Med2018;379(21):2027-39. Abstract

Drilon AE et al. Pivotal ARROS-1 efficacy and safety data: Zidesamtinib in TKI pre-treated patients with advanced/metastatic ROS1+ NSCLC. World Conference on Lung Cancer 2025;Abstract PL02.15.

Drilon AE et al. Phase I/II ALKOVE-1 study of NVL-655 in ALK-positive (ALK+) solid tumours. ESMO 2024;Abstract 1253O.

Drilon AE et al. Repotrectinib in ROS1 fusion-positive non-small-cell lung cancer. N Engl J Med2024;390(2):118-31. Abstract

Drilon AE et al. Long-term efficacy and safety of entrectinib in ROS1 fusion-positive NSCLC. JTO Clin Res Rep 2022;3(6). Abstract

Goto K et al. Trastuzumab deruxtecan in patients with HER2-mutant metastatic non-small-cell lung cancer: Primary results from the randomized, phase II DESTINY-Lung02 trial. J Clin Oncol2023;41(31):4852-63. Abstract

Jänne PA et al. Survival with osimertinib plus chemotherapy in EGFR-mutated advanced NSCLC. N Engl J Med 2025;[Online ahead of print]. Abstract

Le X et al. Sevabertinib (BAY 2927088) in advanced HER2-mutant non-small cell lung cancer (NSCLC): Results from the SOHO-01 study. ESMO 2025;Abstract LBA75.

Leighl NB et al. Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory epidermal growth factor receptor-mutated non-small cell lung cancer: Primary results from the phase III PALOMA-3 study. J Clin Oncol 2024;42(30):3593-605. Abstract

Mok TSK et al. Final overall survival (OS) and safety analysis of the phase III ALEX study of alectinib vs crizotinib in patients with previously untreated, advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC). ESMO 2025;Abstract LBA73. 

Pérol M et al. Taletrectinib in ROS1+ non-small cell lung cancer: TRUST. J Clin Oncol 2025;43(16):1920-9. Abstract

Peters S et al. Alectinib versus crizotinib in previously untreated ALK-positive advanced non-small cell lung cancer: Final overall survival analysis of the Phase III ALEX study. Ann Oncol 2025;[Online ahead of print]. Abstract

Peters S et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med 2017;377(9):829-38. Abstract

Piotrowska Z et al. Zipalertinib in NSCLC patients (pts) with EGFR exon 20 insertion (Ex20Ins) mutations who received prior amivantamab. World Conference on Lung Cancer 2025;Abstract MA08.02.

Popat S et al. Zongertinib as first-line treatment in patients with advanced HER2-mutant NSCLC: Beamion LUNG 1. ESMO 2025;Abstract LBA74.

Popat S et al. Amivantamab plus chemotherapy vs chemotherapy in EGFR-mutated, advanced non-small cell lung cancer after disease progression on osimertinib: Second interim overall survival from MARIPOSA-2. ESMO 2024;Abstract LBA54.

Ramalingam SS et al. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. N Engl J Med 2020;382(1):41-50. Abstract

Smit EF et al. Trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer (DESTINY-Lung01): Primary results of the HER2-overexpressing cohorts from a single-arm, phase 2 trial. Lancet Oncol 2024;25(4):439-54. Abstract

Solomon BJ et al. Lorlatinib vs crizotinib in treatment-naïve patients with advanced ALK+ non-small cell lung cancer: 5-year progression-free survival and safety from the CROWN study. ASCO 2024;Abstract LBA8503.

Waliany S, Lin JJ. Taletrectinib: TRUST in the continued evolution of treatments for ROS1 fusion-positive lung cancer. J Clin Oncol 2024;42(22):2622-7. Abstract

Wang M et al. A multinational phase 2 randomized pivotal study of sunvozertinib in pretreated NSCLC with EGFR exon 20 insertion mutations. World Conference on Lung Cancer 2025;Abstract MA08.01. 

Yang JC-H et al. Overall survival with amivantamab-lazertinib in EGFR-mutated advanced NSCLC. N Engl J Med 2025;393(17):1681-93. Abstract

Yang JC-H et al. Phase II dose-randomized study of sunvozertinib in platinum-pretreated non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations (WU-KONG1B). J Clin Oncol 2025;43(29):3198-208. Abstract

Yu HA et al. Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab. ASCO 2025;Abstract 8503.

Zhou C et al. Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions. N Engl J Med2023;389(22):2039-51. Abstract

Dr Langer

Ahn M-J et al. Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: Primary analysis of the phase 2 IDeate-Lung01 study. World Conference on Lung Cancer 2025;Abstract OA06.03.

Ahn M-J et al. Tarlatamab for patients with previously treated small-cell lung cancer. N Engl J Med2023;389(22):2063-75. Abstract

Boiarsky D et al. Molecular markers of metastatic disease in KRAS-mutant lung adenocarcinoma. Ann Oncol 2023;34(7):589-604. Abstract

Horn L et al. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N Engl J Med 2018;379(23):2220-9. Abstract

Hummel H-D et al. Tarlatamab in previously treated small cell lung cancer (SCLC): DeLLphi-300 phase I study long-term outcomes and intracranial activity. ELCC 2024;Abstract 195MO.

Lu S et al. Phase III study of ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (HARMONi-6). ESMO 2025;Abstract LBA4.

Liu SV et al. Five-year survival in patients with ES-SCLC treated with atezolizumab in IMpower133: Imbrella a extension study results. World Conference on Lung Cancer 2023;Abstract OA01.04.

Paz-Ares L et al. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): A randomised, multicentre, open-label, phase 3 trial. Lancet 2025;405(10495):2129-43. Abstract

Paz-Ares L et al. Tarlatamab for patients (pts) with previously treated small cell lung cancer (SCLC): Primary analysis of the phase II DeLLphi-301 study. ESMO 2023;Abstract LBA92.

Paz-Ares L et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN.ESMO Open 2022;7(2). Abstract

Paz-Ares L et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): A randomised, controlled, open-label, phase 3 trial. Lancet 2019;394(10212):1929-39. Abstract

Peressini M et al. Spatially preserved multi-region transcriptomic subtyping and biomarkers of chemoimmunotherapy outcome in extensive-stage small cell lung cancer. Clin Cancer Res2024;30(14):3036-49. Abstract

Peters S et al. Long-term survival outcomes with first-line nivolumab plus ipilimumab-based treatment in patients with metastatic NSCLC and tumor programmed death-ligand 1 lower than 1%: A pooled analysis. J Thorac Oncol 2025;20(1):94-108. Abstract

Peters S et al. Association between KRAS/STK11/KEAP1 mutations and outcomes in POSEIDON: Durvalumab ± tremelimumab + chemotherapy in mNSCLC. World Conference on Lung Cancer 2022;Abstract OA15.04.

Ricciuti B et al. Diminished efficacy of programmed death-(ligand)1 inhibition in STK11- and KEAP1-mutant lung adenocarcinoma is affected by KRAS mutation status. J Thorac Oncol 2022;17(3):399-410. Abstract

Rudin CM et al. Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of ph3 DeLLphi-304. ASCO 2025;Abstract LBA8008.

Rudin CM et al. Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer (ES-SCLC): Interim analysis of Ideate-lung01. World Conference on Lung Cancer 2024;Abstract OA04.03.

Rudin CM et al. Pembrolizumab or placebo plus etoposide and platinum as first-line therapy for extensive-stage small-cell lung cancer: Randomized, double-blind, phase III KEYNOTE-604 study. J Clin Oncol 2020;38(21):2369-79. Abstract

Senan S et al. Durvalumab (D) as consolidation therapy in limited-stage SCLC (LS-SCLC): Outcomes by prior concurrent chemoradiotherapy (cCRT) regimen and prophylactic cranial irradiation (PCI) use in the ADRIATIC trial. ESMO 2024;Abstract LBA81.

Skoulidis F et al. CTLA4 blockade abrogates KEAP1/STK11-related resistance to PD-(L)1 inhibitors.Nature 2024;635(8038):462-71. Abstract

Skoulidis F et al. TRITON: Phase 3b study of tremelimumab (T) + durvalumab (D) vs pembrolizumab (P), in combination with chemotherapy (CT), in non-squamous (NSQ) metastatic NSCLC (mNSCLC) with STK11 and/or KEAP1 and/or KRAS mutations. ASCO 2024;Abstract TPS8655.

Spigel DR et al. ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC). ASCO 2024;Abstract LBA5.

Xiong A et al. Ivonescimab versus pembrolizumab for PD-L1-positive NSCLC: A subgroup analysis of HARMONi-2 by tumor histology. World Conference on Lung Cancer 2025;Abstract P1.11.83.

Zhou C et al. Safety and efficacy of QLC5508 in previously treated patients with small cell lung cancer: Updated data from a phase 1 study. World Conference on Lung Cancer 2025;Abstract OA06.02.

Zhou C et al. Phase 3 study of ivonescimab (AK112) vs. pembrolizumab as first-line treatment for PD-L1-positive advanced NSCLC: Primary analysis of HARMONi-2. World Conference on Lung Cancer 2024;Abstract PL02.04.

Dr Shields

Besse B et al. Adjuvant pembrolizumab versus placebo for early-stage NSCLC after resection and optional chemotherapy: Updated results from PEARLS/KEYNOTE-091. ESMO Immuno-Oncology Congress 2023;Abstract 120MO.

Cascone T et al. Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: Updated survival and biomarker analyses from CheckMate 77T. ASCO 2025;Abstract LBA8010.

Felip E et al. Five-year survival outcomes with atezolizumab after chemotherapy in resected stage IB-IIIA non-small cell lung cancer (IMpower010): An open-label, randomized, phase III trial. J Clin Oncol 2025;43(21):2343-9. Abstract

Forde PM et al. Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816. ASCO 2025;Abstract LBA8000.

Heymach JV et al. Perioperative durvalumab for resectable NSCLC (R-NSCLC): Updated outcomes from the phase 3 AEGEAN trial. World Conference on Lung Cancer 2024;Abstract OA13.03.

Wakelee HA et al. Perioperative pembrolizumab in early-stage non-small-cell lung cancer (NSCLC): 5-year follow-up from KEYNOTE-671. ESMO 2025;Abstract LBA67.

Wakelee HA et al. IMpower010: Final disease-free survival (DFS) and second overall survival (OS) interim results after ≥5 years of follow up of a phase III study of adjuvant atezolizumab vs best supportive care in resected stage IB-IIIA non-small cell lung cancer (NSCLC). ASCO 2024;Abstract LBA8035. 

Chronic Lymphocytic Leukemia

Dr Rogers 

Al-Sawaf O et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized phase 3 CLL14 study. Blood 2024;144(18):1924-35. Abstract

Brown JR et al. Fixed-duration acalabrutinib combinations in untreated chronic lymphocytic leukemia.N Engl J Med 2025;392(8):748-62. Abstract 

Brown JR et al. Fixed-duration acalabrutinib plus venetoclax with or without obinutuzumab versus chemoimmunotherapy for first-line treatment of chronic lymphocytic leukemia: Interim analysis of the multicenter, open-label, randomized, phase 3 AMPLIFY trial. ASH 2024;Abstract 1009. 

Burger JR et al. Final analysis of the RESONATE-2 study: Up to 10 years of follow-up of first-line ibrutinib treatment in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. EHA 2024;Abstract P670. 

Fürstenau M et al. First-line venetoclax combinations versus chemoimmunotherapy in fit patients with chronic lymphocytic leukaemia (GAIA/CLL13): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 2024;25(6):744-59. Abstract

Ghia P et al. First-line ibrutinib treatment in patients with chronic lymphocytic leukemia is associated with overall survival rates similar to those of an age-matched general population: A pooled post hoc analysis. Hemasphere 2024;8(5):e74. Abstract

Patten PEM et al. CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naive CLL.ASH 2024;Abstract 3257.1. 

Scarfo L et al. Updated efficacy and safety of the Bruton tyrosine kinase (BTK) degrader BGB-16673 in patients (PTS) with relapsed or refractory (R/R) CLL/SLL: Results from the ongoing phase (PH) 1 CADANCE-101 study. EHA 2025;Abstract S158. 

Shadman M et al. Combination of zanubrutinib (zanu) + venetoclax (ven) for treatment-naive (TN) CLL/SLL: Results in SEQUOIA arm D. ASCO 2025;Abstract 7009. 

Sharman JP et al. Phase III trial of pirtobrutinib versus idelalisib/rituximab or bendamustine/rituximab in covalent Bruton tyrosine kinase inhibitor-pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (BRUIN CLL-321). J Clin Oncol 2025;43(22):2538-49. Abstract

Sharman JP et al. BRUIN CLL-321: Randomized phase III trial of pirtobrutinib versus idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in BTK inhibitor pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma. ASH 2024;Abstract 886. 

Sharman JP et al. Acalabrutinib ± obinutuzumab vs obinutuzumab + chlorambucil in treatment-naive chronic lymphocytic leukemia: 6-year follow-up of Elevate-TN. ASH 2023;Abstract 636. 

Soumerai JD et al. Multicenter phase II trial of zanubrutinib, obinutuzumab, and venetoclax (BOVen) in treatment-naïve chronic lymphocytic leukemia: 5-year follow up, retreatment outcomes, and impact of MRD kinetics (ΔMRD400). ASH 2024;Abstract 1867. 

Soumerai JD et al. Sonrotoclax and zanubrutinib as frontline treatment for CLL demonstrates high MRD clearance rates with good tolerability: Data from an ongoing phase 1/1b study BGB-11417-101. ASH 2024;Abstract 1012. 

Tam CSL et al. SEQUOIA 5-year follow-up in arm C: Frontline zanubrutinib monotherapy in patients with del(17p) and treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). ASCO 2025;Abstract 7011. 

Woyach J et al. Pirtobrutinib vs ibrutinib in treatment-naïve and relapsed/refractory CLL/SLL: Results from the first randomized phase III study comparing a non-covalent and covalent BTK inhibitor. ASH 2025;Abstract abs25-2587. 

Ovarian Cancer

Dr Konecny 

Alvarez Secord A et al. Final analysis of the single-arm phase II PICCOLO trial of mirvetuximab soravtansine-gynx (MIRV) in folate receptor alpha (FRα)-positive, third-line and later (3L+), recurrent platinum-sensitive ovarian cancer (PSOC). ESMO Gynaecological Cancers 2025;Abstract 76MO. 

Colombo N et al. Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind phase III ENGOT-ov65/KEYNOTE-B96 study. ESMO 2025;Abstract LBA3. 

González-Martin A et al. Final overall survival (OS) in patients (pts) with newly diagnosed advanced ovarian cancer (aOC) treated with niraparib (nir) first-line (1L) maintenance: Results from PRIMA/ENGOT-OV26/GOG-3012. ESMO 2024;Abstract LBA29. 

Makker V et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) part 1 final analysis. ESMO 2025;Abstract 957P. 

Meric-Bernstam F et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: Primary analysis from the DESTINY-PanTumor02 (DP-02) study. ESMO 2023;Abstract LBA34. 

Moore KN et al. Second progression-free survival (PFS2) and subsequent treatment in patients (pts) with folate receptor alpha (FR⍺)-positive platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs investigator’s choice chemotherapy (ICC): Phase III MIRASOL trial. ESMO 2025;Abstract 1068P. 

Olawaiye A et al. ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). ASCO 2025;Abstract LBA5507. 

Ray-Coquard IL et al. Raludotatug deruxtecan (R-DXd) in patients (pts) with platinum-resistant ovarian cancer (PROC): Primary analysis of the phase II dose-optimization part of REJOICE-Ovarian01. ESMO 2025;Abstract LBA42. 

Van Gorp T et al. Final overall survival analysis among patients with folate receptor alpha-positive, platinum-resistant ovarian cancer treated with mirvetuximab soravtansine versus investigator’s choice chemotherapy in phase II MIRASOL (GOG-3045/ENGOT-ov55) study. SGO 2025;Abstract 939696. 

Gastroesophageal Cancers

Dr Shah

Baek JH et al. Clinical implications of Claudin18.2 expression in patients with gastric cancer.Anticancer Res 2019;39(12):6973-9. Abstract

Elimova E et al. Long-term outcomes and overall survival (OS) for zanidatamab + chemotherapy in HER2-positive (HER2+) advanced or metastatic gastroesophageal adenocarcinoma (mGEA): 4-year follow-up of a phase 2 trial. ASCO 2025;Abstract 4013. 

Janjigian YY et al. Final overall survival for the phase III, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. ESMO 2024;Abstract 1400O. 

Janjigian YY et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): A randomised, open-label, phase 3 trial. Lancet 2021;398(10294):27-40. Abstract

Kuwata T. Molecular classification and intratumoral heterogeneity of gastric adenocarcinoma. Pathol Int 2024;74(6):301-16. Abstract

Martins F et al. Adverse effects of immune-checkpoint inhibitors: epidemiology, management and surveillance. Nat Rev Clin Oncol 2019;16(9):563-80. Abstract

Moehler MH et al. Rationale 305: Phase 3 study of tislelizumab plus chemotherapy vs placebo plus chemotherapy as first-line treatment (1L) of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). Gastrointestinal Cancers Symposium 2023;Abstract 286. 

Rha SY et al. Bemarituzumab (BEMA) plus chemotherapy for advanced or metastatic FGFR2b-overexpressing gastric or gastroesophageal junction cancer (G/GEJC): FORTITUDE-101 phase III study results. ESMO 2025;Abstract LBA10. 

Rha SY et al. Prevalence of FGFR2b protein overexpression in advanced gastric cancers during prescreening for the phase III FORTITUDE-101 trial. JCO Precis Oncol 2025;9. Abstract

Rha SY et al. Pembrolizumab (pembro) plus chemotherapy (chemo) as first-line therapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer: Phase III KEYNOTE-859 study.ESMO Virtual Plenary 2023;Abstract VP1-2023. 

Sato S et al. Clinical characterization of FGFR2b expression in patients with advanced gastric or gastroesophageal junction adenocarcinoma. ESMO Open 2025;10(7). Abstract

Shitara K et al. Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) + paclitaxel (PTX) in second-line treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA): Primary analysis of the randomized, phase 3 DESTINY-Gastric04 study. ASCO 2025;Abstract LBA4002. 

Shitara K et al. Zolbetuximab in gastric or gastroesophageal junction adenocarcinoma. N Engl J Med2024;391(12):1159-62. Abstract

Wainberg ZA et al. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): A randomised, double-blind, placebo-controlled, phase 2 study.Lancet Oncol 2022;23(11):1430-40. Abstract

Wainberg ZA et al. Randomized double-blind placebo-controlled phase 2 study of bemarituzumab combined with modified FOLFOX6 (mFOLFOX6) in first-line (1L) treatment of advanced gastric/gastroesophageal junction adenocarcinoma (FIGHT). Gastrointestinal Cancers Symposium 2021;Abstract 160. 

Yashiro M et al. Clinical difference between fibroblast growth factor receptor 2 subclass, type IIIb and type IIIc, in gastric cancer. Sci Rep 2021;11(1):4698. Abstract

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, surgeons, radiation oncologists, pharmacists, nurse practitioners, clinical nurse specialists and other healthcare professionals involved in the treatment of cancer.

LEARNING OBJECTIVES

• Appraise the clinical relevance of recent pivotal cancer research published in peer-reviewed journals or presented at major oncology conferences.
• Recall ongoing clinical trials in select hematologic cancers and solid tumors, and as appropriate, refer patients for participation.
• Incorporate individual preferences, tumor biomarkers and other treatment-related factors in personalizing therapy for patients with cancer.
• Educate patients with hematologic cancers or solid tumors about the benefits and risks of novel therapeutic agents and strategies.
• Apply an awareness of new datasets and the perspectives of tumor-specific clinical investigators to refine or validate treatment algorithms.
• Evaluate the mechanisms of action, tolerability and efficacy of promising investigational agents, and consider the implications for clinical practice. 

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 4.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 4.5 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology and hematology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology. 

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/AON25/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Justin F Gainor, MD
Director, Center for Thoracic Cancers Program
Director of Targeted Immunotherapy in the Henri and Belinda Termeer Center for Targeted Therapies
Massachusetts General Hospital
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Advisory Committees: Amgen Inc, ARS Pharmaceuticals, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Genentech, a member of the Roche Group, Gilead Sciences Inc, ITeos Therapeutics, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Mariana Oncology, Merck, Merus, Mirati Therapeutics Inc, Moderna, Novartis, Novocure Inc, Nuvalent, Pfizer Inc, Sanofi, Takeda Pharmaceuticals USA Inc; Consulting Agreements: Merck, Novartis, Pfizer Inc, Takeda Pharmaceuticals USA Inc; Contracted Research: Adaptimmune, ALX Oncology, AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Bristol Myers Squibb, Genentech, a member of the Roche Group, Jounce Therapeutics, Merck, Moderna, NextPoint Therapeutics, Novartis, Palleon Pharmaceuticals; Nonrelevant Financial Relationships: AI Proteins.

Gottfried E Konecny, MD
Professor of Medicine and Ob/Gyn
Director, Medical Gynecologic Oncology
Division of Hematology and Oncology
David Geffen School of Medicine
University of California, Los Angeles
Los Angeles, California

No relevant conflicts of interest to disclose.

Corey J Langer, MD
Director of Thoracic Oncology
Abramson Cancer Center
Professor of Medicine
Perelman School of Medicine
University of Pennsylvania
Philadelphia, Pennsylvania

Advisory Committees: Amgen Inc, Merck; Consulting Agreements: Aptitude Health, Boehringer Ingelheim Pharmaceuticals Inc, Catalyst Pharmaceuticals Inc, EMD Serono Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Merck, Pfizer Inc, Regeneron Pharmaceuticals Inc; Contracted Research (Institutional Support for Clinical Research): Amgen Inc, FUJIFILM Pharmaceuticals USA Inc, Novocure Inc; Data and Safety Monitoring Boards/Committees: Incyte Corporation, Summit Therapeutics; Nonrelevant Financial Relationships: Valor (VA).

Kerry A Rogers, MD
Associate Professor
Division of Hematology
The Ohio State University
Columbus, Ohio

Advisory Committees: Genentech, a member of the Roche Group, Janssen Biotech Inc; Consulting Agreements: AbbVie Inc, Alpine Immune Sciences, AstraZeneca Pharmaceuticals LP, BeOne, Genentech, a member of the Roche Group, Lilly; Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Lilly; Data and Safety Monitoring Boards/Committees:AstraZeneca Pharmaceuticals LP.

Manish A Shah, MD
Professor of Medicine
Bartlett Family Professor of Gastrointestinal Oncology
Chief, Solid Tumor Oncology
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York

No relevant conflicts of interest to disclose.

Misty Dawn Shields, MD, PhD
Assistant Professor of Clinical Medicine
Indiana University School of Medicine
Adjunct Assistant Professor of Medical and Molecular Genetics
Associate Member, Experimental and Developmental Therapeutics
Department of Medicine, Division of Hematology/Oncology, Thoracic Oncology
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana

Steering Committees: AstraZeneca Pharmaceuticals LP.

MODERATOR
Stephen “Fred” Divers, MD 
Chief Medical Officer
American Oncology Network
Hot Springs, Arkansas

Advisory Committees: Daiichi Sankyo Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AbbVie Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeOne, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Merck, and Nuvalent.

Release date: December 2025
Expiration date: December 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Lung Cancer

Dr Gainor

Ahn M-J et al. Efficacy and safety of datopotamab deruxtecan (Dato-DXd) in patients (pts) with previously-treated EGFR-mutated advanced non-small cell lung cancer (NSCLC): A pooled analysis of TROPION-Lung01 and TROPION-Lung05. ESMO Asia 2024;Abstract LBA7.

Camidge DR et al. Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer. N Engl J Med2018;379(21):2027-39. Abstract

Drilon AE et al. Pivotal ARROS-1 efficacy and safety data: Zidesamtinib in TKI pre-treated patients with advanced/metastatic ROS1+ NSCLC. World Conference on Lung Cancer 2025;Abstract PL02.15.

Drilon AE et al. Phase I/II ALKOVE-1 study of NVL-655 in ALK-positive (ALK+) solid tumours. ESMO 2024;Abstract 1253O.

Drilon AE et al. Repotrectinib in ROS1 fusion-positive non-small-cell lung cancer. N Engl J Med2024;390(2):118-31. Abstract

Drilon AE et al. Long-term efficacy and safety of entrectinib in ROS1 fusion-positive NSCLC. JTO Clin Res Rep 2022;3(6). Abstract

Goto K et al. Trastuzumab deruxtecan in patients with HER2-mutant metastatic non-small-cell lung cancer: Primary results from the randomized, phase II DESTINY-Lung02 trial. J Clin Oncol2023;41(31):4852-63. Abstract

Jänne PA et al. Survival with osimertinib plus chemotherapy in EGFR-mutated advanced NSCLC. N Engl J Med 2025;[Online ahead of print]. Abstract

Le X et al. Sevabertinib (BAY 2927088) in advanced HER2-mutant non-small cell lung cancer (NSCLC): Results from the SOHO-01 study. ESMO 2025;Abstract LBA75.

Leighl NB et al. Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory epidermal growth factor receptor-mutated non-small cell lung cancer: Primary results from the phase III PALOMA-3 study. J Clin Oncol 2024;42(30):3593-605. Abstract

Mok TSK et al. Final overall survival (OS) and safety analysis of the phase III ALEX study of alectinib vs crizotinib in patients with previously untreated, advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC). ESMO 2025;Abstract LBA73. 

Pérol M et al. Taletrectinib in ROS1+ non-small cell lung cancer: TRUST. J Clin Oncol 2025;43(16):1920-9. Abstract

Peters S et al. Alectinib versus crizotinib in previously untreated ALK-positive advanced non-small cell lung cancer: Final overall survival analysis of the Phase III ALEX study. Ann Oncol 2025;[Online ahead of print]. Abstract

Peters S et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med 2017;377(9):829-38. Abstract

Piotrowska Z et al. Zipalertinib in NSCLC patients (pts) with EGFR exon 20 insertion (Ex20Ins) mutations who received prior amivantamab. World Conference on Lung Cancer 2025;Abstract MA08.02.

Popat S et al. Zongertinib as first-line treatment in patients with advanced HER2-mutant NSCLC: Beamion LUNG 1. ESMO 2025;Abstract LBA74.

Popat S et al. Amivantamab plus chemotherapy vs chemotherapy in EGFR-mutated, advanced non-small cell lung cancer after disease progression on osimertinib: Second interim overall survival from MARIPOSA-2. ESMO 2024;Abstract LBA54.

Ramalingam SS et al. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. N Engl J Med 2020;382(1):41-50. Abstract

Smit EF et al. Trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer (DESTINY-Lung01): Primary results of the HER2-overexpressing cohorts from a single-arm, phase 2 trial. Lancet Oncol 2024;25(4):439-54. Abstract

Solomon BJ et al. Lorlatinib vs crizotinib in treatment-naïve patients with advanced ALK+ non-small cell lung cancer: 5-year progression-free survival and safety from the CROWN study. ASCO 2024;Abstract LBA8503.

Waliany S, Lin JJ. Taletrectinib: TRUST in the continued evolution of treatments for ROS1 fusion-positive lung cancer. J Clin Oncol 2024;42(22):2622-7. Abstract

Wang M et al. A multinational phase 2 randomized pivotal study of sunvozertinib in pretreated NSCLC with EGFR exon 20 insertion mutations. World Conference on Lung Cancer 2025;Abstract MA08.01. 

Yang JC-H et al. Overall survival with amivantamab-lazertinib in EGFR-mutated advanced NSCLC. N Engl J Med 2025;393(17):1681-93. Abstract

Yang JC-H et al. Phase II dose-randomized study of sunvozertinib in platinum-pretreated non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations (WU-KONG1B). J Clin Oncol 2025;43(29):3198-208. Abstract

Yu HA et al. Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab. ASCO 2025;Abstract 8503.

Zhou C et al. Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions. N Engl J Med2023;389(22):2039-51. Abstract

Dr Langer

Ahn M-J et al. Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: Primary analysis of the phase 2 IDeate-Lung01 study. World Conference on Lung Cancer 2025;Abstract OA06.03.

Ahn M-J et al. Tarlatamab for patients with previously treated small-cell lung cancer. N Engl J Med2023;389(22):2063-75. Abstract

Boiarsky D et al. Molecular markers of metastatic disease in KRAS-mutant lung adenocarcinoma. Ann Oncol 2023;34(7):589-604. Abstract

Horn L et al. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N Engl J Med 2018;379(23):2220-9. Abstract

Hummel H-D et al. Tarlatamab in previously treated small cell lung cancer (SCLC): DeLLphi-300 phase I study long-term outcomes and intracranial activity. ELCC 2024;Abstract 195MO.

Lu S et al. Phase III study of ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (HARMONi-6). ESMO 2025;Abstract LBA4.

Liu SV et al. Five-year survival in patients with ES-SCLC treated with atezolizumab in IMpower133: Imbrella a extension study results. World Conference on Lung Cancer 2023;Abstract OA01.04.

Paz-Ares L et al. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): A randomised, multicentre, open-label, phase 3 trial. Lancet 2025;405(10495):2129-43. Abstract

Paz-Ares L et al. Tarlatamab for patients (pts) with previously treated small cell lung cancer (SCLC): Primary analysis of the phase II DeLLphi-301 study. ESMO 2023;Abstract LBA92.

Paz-Ares L et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN.ESMO Open 2022;7(2). Abstract

Paz-Ares L et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): A randomised, controlled, open-label, phase 3 trial. Lancet 2019;394(10212):1929-39. Abstract

Peressini M et al. Spatially preserved multi-region transcriptomic subtyping and biomarkers of chemoimmunotherapy outcome in extensive-stage small cell lung cancer. Clin Cancer Res2024;30(14):3036-49. Abstract

Peters S et al. Long-term survival outcomes with first-line nivolumab plus ipilimumab-based treatment in patients with metastatic NSCLC and tumor programmed death-ligand 1 lower than 1%: A pooled analysis. J Thorac Oncol 2025;20(1):94-108. Abstract

Peters S et al. Association between KRAS/STK11/KEAP1 mutations and outcomes in POSEIDON: Durvalumab ± tremelimumab + chemotherapy in mNSCLC. World Conference on Lung Cancer 2022;Abstract OA15.04.

Ricciuti B et al. Diminished efficacy of programmed death-(ligand)1 inhibition in STK11- and KEAP1-mutant lung adenocarcinoma is affected by KRAS mutation status. J Thorac Oncol 2022;17(3):399-410. Abstract

Rudin CM et al. Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of ph3 DeLLphi-304. ASCO 2025;Abstract LBA8008.

Rudin CM et al. Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer (ES-SCLC): Interim analysis of Ideate-lung01. World Conference on Lung Cancer 2024;Abstract OA04.03.

Rudin CM et al. Pembrolizumab or placebo plus etoposide and platinum as first-line therapy for extensive-stage small-cell lung cancer: Randomized, double-blind, phase III KEYNOTE-604 study. J Clin Oncol 2020;38(21):2369-79. Abstract

Senan S et al. Durvalumab (D) as consolidation therapy in limited-stage SCLC (LS-SCLC): Outcomes by prior concurrent chemoradiotherapy (cCRT) regimen and prophylactic cranial irradiation (PCI) use in the ADRIATIC trial. ESMO 2024;Abstract LBA81.

Skoulidis F et al. CTLA4 blockade abrogates KEAP1/STK11-related resistance to PD-(L)1 inhibitors.Nature 2024;635(8038):462-71. Abstract

Skoulidis F et al. TRITON: Phase 3b study of tremelimumab (T) + durvalumab (D) vs pembrolizumab (P), in combination with chemotherapy (CT), in non-squamous (NSQ) metastatic NSCLC (mNSCLC) with STK11 and/or KEAP1 and/or KRAS mutations. ASCO 2024;Abstract TPS8655.

Spigel DR et al. ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC). ASCO 2024;Abstract LBA5.

Xiong A et al. Ivonescimab versus pembrolizumab for PD-L1-positive NSCLC: A subgroup analysis of HARMONi-2 by tumor histology. World Conference on Lung Cancer 2025;Abstract P1.11.83.

Zhou C et al. Safety and efficacy of QLC5508 in previously treated patients with small cell lung cancer: Updated data from a phase 1 study. World Conference on Lung Cancer 2025;Abstract OA06.02.

Zhou C et al. Phase 3 study of ivonescimab (AK112) vs. pembrolizumab as first-line treatment for PD-L1-positive advanced NSCLC: Primary analysis of HARMONi-2. World Conference on Lung Cancer 2024;Abstract PL02.04.

Dr Shields

Besse B et al. Adjuvant pembrolizumab versus placebo for early-stage NSCLC after resection and optional chemotherapy: Updated results from PEARLS/KEYNOTE-091. ESMO Immuno-Oncology Congress 2023;Abstract 120MO.

Cascone T et al. Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: Updated survival and biomarker analyses from CheckMate 77T. ASCO 2025;Abstract LBA8010.

Felip E et al. Five-year survival outcomes with atezolizumab after chemotherapy in resected stage IB-IIIA non-small cell lung cancer (IMpower010): An open-label, randomized, phase III trial. J Clin Oncol 2025;43(21):2343-9. Abstract

Forde PM et al. Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816. ASCO 2025;Abstract LBA8000.

Heymach JV et al. Perioperative durvalumab for resectable NSCLC (R-NSCLC): Updated outcomes from the phase 3 AEGEAN trial. World Conference on Lung Cancer 2024;Abstract OA13.03.

Wakelee HA et al. Perioperative pembrolizumab in early-stage non-small-cell lung cancer (NSCLC): 5-year follow-up from KEYNOTE-671. ESMO 2025;Abstract LBA67.

Wakelee HA et al. IMpower010: Final disease-free survival (DFS) and second overall survival (OS) interim results after ≥5 years of follow up of a phase III study of adjuvant atezolizumab vs best supportive care in resected stage IB-IIIA non-small cell lung cancer (NSCLC). ASCO 2024;Abstract LBA8035. 

Chronic Lymphocytic Leukemia

Dr Rogers 

Al-Sawaf O et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized phase 3 CLL14 study. Blood 2024;144(18):1924-35. Abstract

Brown JR et al. Fixed-duration acalabrutinib combinations in untreated chronic lymphocytic leukemia.N Engl J Med 2025;392(8):748-62. Abstract 

Brown JR et al. Fixed-duration acalabrutinib plus venetoclax with or without obinutuzumab versus chemoimmunotherapy for first-line treatment of chronic lymphocytic leukemia: Interim analysis of the multicenter, open-label, randomized, phase 3 AMPLIFY trial. ASH 2024;Abstract 1009. 

Burger JR et al. Final analysis of the RESONATE-2 study: Up to 10 years of follow-up of first-line ibrutinib treatment in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. EHA 2024;Abstract P670. 

Fürstenau M et al. First-line venetoclax combinations versus chemoimmunotherapy in fit patients with chronic lymphocytic leukaemia (GAIA/CLL13): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 2024;25(6):744-59. Abstract

Ghia P et al. First-line ibrutinib treatment in patients with chronic lymphocytic leukemia is associated with overall survival rates similar to those of an age-matched general population: A pooled post hoc analysis. Hemasphere 2024;8(5):e74. Abstract

Patten PEM et al. CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naive CLL.ASH 2024;Abstract 3257.1. 

Scarfo L et al. Updated efficacy and safety of the Bruton tyrosine kinase (BTK) degrader BGB-16673 in patients (PTS) with relapsed or refractory (R/R) CLL/SLL: Results from the ongoing phase (PH) 1 CADANCE-101 study. EHA 2025;Abstract S158. 

Shadman M et al. Combination of zanubrutinib (zanu) + venetoclax (ven) for treatment-naive (TN) CLL/SLL: Results in SEQUOIA arm D. ASCO 2025;Abstract 7009. 

Sharman JP et al. Phase III trial of pirtobrutinib versus idelalisib/rituximab or bendamustine/rituximab in covalent Bruton tyrosine kinase inhibitor-pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (BRUIN CLL-321). J Clin Oncol 2025;43(22):2538-49. Abstract

Sharman JP et al. BRUIN CLL-321: Randomized phase III trial of pirtobrutinib versus idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in BTK inhibitor pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma. ASH 2024;Abstract 886. 

Sharman JP et al. Acalabrutinib ± obinutuzumab vs obinutuzumab + chlorambucil in treatment-naive chronic lymphocytic leukemia: 6-year follow-up of Elevate-TN. ASH 2023;Abstract 636. 

Soumerai JD et al. Multicenter phase II trial of zanubrutinib, obinutuzumab, and venetoclax (BOVen) in treatment-naïve chronic lymphocytic leukemia: 5-year follow up, retreatment outcomes, and impact of MRD kinetics (ΔMRD400). ASH 2024;Abstract 1867. 

Soumerai JD et al. Sonrotoclax and zanubrutinib as frontline treatment for CLL demonstrates high MRD clearance rates with good tolerability: Data from an ongoing phase 1/1b study BGB-11417-101. ASH 2024;Abstract 1012. 

Tam CSL et al. SEQUOIA 5-year follow-up in arm C: Frontline zanubrutinib monotherapy in patients with del(17p) and treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). ASCO 2025;Abstract 7011. 

Woyach J et al. Pirtobrutinib vs ibrutinib in treatment-naïve and relapsed/refractory CLL/SLL: Results from the first randomized phase III study comparing a non-covalent and covalent BTK inhibitor. ASH 2025;Abstract abs25-2587. 

Ovarian Cancer

Dr Konecny 

Alvarez Secord A et al. Final analysis of the single-arm phase II PICCOLO trial of mirvetuximab soravtansine-gynx (MIRV) in folate receptor alpha (FRα)-positive, third-line and later (3L+), recurrent platinum-sensitive ovarian cancer (PSOC). ESMO Gynaecological Cancers 2025;Abstract 76MO. 

Colombo N et al. Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind phase III ENGOT-ov65/KEYNOTE-B96 study. ESMO 2025;Abstract LBA3. 

González-Martin A et al. Final overall survival (OS) in patients (pts) with newly diagnosed advanced ovarian cancer (aOC) treated with niraparib (nir) first-line (1L) maintenance: Results from PRIMA/ENGOT-OV26/GOG-3012. ESMO 2024;Abstract LBA29. 

Makker V et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) part 1 final analysis. ESMO 2025;Abstract 957P. 

Meric-Bernstam F et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: Primary analysis from the DESTINY-PanTumor02 (DP-02) study. ESMO 2023;Abstract LBA34. 

Moore KN et al. Second progression-free survival (PFS2) and subsequent treatment in patients (pts) with folate receptor alpha (FR⍺)-positive platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs investigator’s choice chemotherapy (ICC): Phase III MIRASOL trial. ESMO 2025;Abstract 1068P. 

Olawaiye A et al. ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). ASCO 2025;Abstract LBA5507. 

Ray-Coquard IL et al. Raludotatug deruxtecan (R-DXd) in patients (pts) with platinum-resistant ovarian cancer (PROC): Primary analysis of the phase II dose-optimization part of REJOICE-Ovarian01. ESMO 2025;Abstract LBA42. 

Van Gorp T et al. Final overall survival analysis among patients with folate receptor alpha-positive, platinum-resistant ovarian cancer treated with mirvetuximab soravtansine versus investigator’s choice chemotherapy in phase II MIRASOL (GOG-3045/ENGOT-ov55) study. SGO 2025;Abstract 939696. 

Gastroesophageal Cancers

Dr Shah

Baek JH et al. Clinical implications of Claudin18.2 expression in patients with gastric cancer.Anticancer Res 2019;39(12):6973-9. Abstract

Elimova E et al. Long-term outcomes and overall survival (OS) for zanidatamab + chemotherapy in HER2-positive (HER2+) advanced or metastatic gastroesophageal adenocarcinoma (mGEA): 4-year follow-up of a phase 2 trial. ASCO 2025;Abstract 4013. 

Janjigian YY et al. Final overall survival for the phase III, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. ESMO 2024;Abstract 1400O. 

Janjigian YY et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): A randomised, open-label, phase 3 trial. Lancet 2021;398(10294):27-40. Abstract

Kuwata T. Molecular classification and intratumoral heterogeneity of gastric adenocarcinoma. Pathol Int 2024;74(6):301-16. Abstract

Martins F et al. Adverse effects of immune-checkpoint inhibitors: epidemiology, management and surveillance. Nat Rev Clin Oncol 2019;16(9):563-80. Abstract

Moehler MH et al. Rationale 305: Phase 3 study of tislelizumab plus chemotherapy vs placebo plus chemotherapy as first-line treatment (1L) of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). Gastrointestinal Cancers Symposium 2023;Abstract 286. 

Rha SY et al. Bemarituzumab (BEMA) plus chemotherapy for advanced or metastatic FGFR2b-overexpressing gastric or gastroesophageal junction cancer (G/GEJC): FORTITUDE-101 phase III study results. ESMO 2025;Abstract LBA10. 

Rha SY et al. Prevalence of FGFR2b protein overexpression in advanced gastric cancers during prescreening for the phase III FORTITUDE-101 trial. JCO Precis Oncol 2025;9. Abstract

Rha SY et al. Pembrolizumab (pembro) plus chemotherapy (chemo) as first-line therapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer: Phase III KEYNOTE-859 study.ESMO Virtual Plenary 2023;Abstract VP1-2023. 

Sato S et al. Clinical characterization of FGFR2b expression in patients with advanced gastric or gastroesophageal junction adenocarcinoma. ESMO Open 2025;10(7). Abstract

Shitara K et al. Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) + paclitaxel (PTX) in second-line treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA): Primary analysis of the randomized, phase 3 DESTINY-Gastric04 study. ASCO 2025;Abstract LBA4002. 

Shitara K et al. Zolbetuximab in gastric or gastroesophageal junction adenocarcinoma. N Engl J Med2024;391(12):1159-62. Abstract

Wainberg ZA et al. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): A randomised, double-blind, placebo-controlled, phase 2 study.Lancet Oncol 2022;23(11):1430-40. Abstract

Wainberg ZA et al. Randomized double-blind placebo-controlled phase 2 study of bemarituzumab combined with modified FOLFOX6 (mFOLFOX6) in first-line (1L) treatment of advanced gastric/gastroesophageal junction adenocarcinoma (FIGHT). Gastrointestinal Cancers Symposium 2021;Abstract 160. 

Yashiro M et al. Clinical difference between fibroblast growth factor receptor 2 subclass, type IIIb and type IIIc, in gastric cancer. Sci Rep 2021;11(1):4698. Abstract