Faculty

TARGET AUDIENCE
This program is intended for gynecologic oncologists, medical oncologists, gynecologists and other healthcare providers involved in the treatment of ovarian cancer.

LEARNING OBJECTIVES

• Understand available clinical research findings with PARP inhibitors as maintenance therapy after first-line platinum-based chemotherapy for advanced OC, and appropriately counsel patients regarding personalized treatment recommendations.
• Appraise biological and patient- and treatment-related factors to individualize the selection and sequencing of therapy for platinum-sensitive and platinum-resistant recurrent OC.
• Recognize the rationale for targeting FRα in OC, and understand the mechanism of action of and available research findings with FRα-directed antibody-drug conjugates.
• Appreciate available clinical research findings with anti-PD-1/PD-L1 antibodies in combination with chemotherapy for patients with platinum-resistant OC, and consider the current role of this novel therapeutic strategy.
• Understand the biological justification for the evaluation of selective glucocorticoid receptor modulators in combination with chemotherapy for patients with platinum-resistant OC, and recall available and emerging Phase III findings with this novel approach.
• Recognize adverse events associated with therapeutic approaches commonly employed for OC, and implement strategies to educate patients and manage complications.
• Describe the scientific justification for, published research data with and current research studies of novel agents and strategies for OC, and effectively prioritize clinical trial opportunities for eligible patients.

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
Research To Practice designates this enduring material for a maximum of 1.75 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 this CME activity, which includes participation in the evaluation component and post-test, enables the participant to earn up to 1.75 (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, this program has been specifically designed for the following ABIM specialty: medical oncology. 

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and post-test, 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, this program has 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/SGO26Ovarian/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:

Nicoletta Colombo, MD
Director, Gynecologic Oncology Program
European Institute of Oncology IRCCS
Milan, Italy

Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, BioNTech SE, Corcept Therapeutics Inc, Eisai Inc, Gilead Sciences Inc, GSK, ImmunoGen Inc, Lilly, MSD, Novocure Inc, Regeneron Pharmaceuticals Inc, Seagen Inc; Data and Safety Monitoring Boards/Committees: Incyte Corporation; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Eisai Inc, GSK, MSD.

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.

Alexander B Olawaiye, MD 
Professor
Department of Obstetrics, Gynecology and Reproductive Sciences
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania

Advisory Committees: AstraZeneca Pharmaceuticals LP, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Eisai Inc, GSK, Lilly, Merck; Consulting Agreements: Corcept Therapeutics Inc; Speakers Bureaus: Foundation Medicine.

CONSULTING CLINICAL INVESTIGATORS
Professor Jonathan A Ledermann — Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Flindr, GSK, ImmunoGen Inc, MSD, Novocure Inc; Consulting Agreements: AbbVie Inc, GSK; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Sutro Biopharma, Zentalis Pharmaceuticals; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, GSK, Medison Pharmaceuticals, MSD. Ursula Matulonis, MD — Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Day One Biopharmaceuticals, GSK, NextCure, Novartis, Tango Therapeutics; Consulting Agreements: Whitehawk Therapeutics; Data and Safety Monitoring Boards/Committees: Daiichi Sankyo Inc, MacroGenics Inc, Mural Oncology Inc, Symphogen A/S. Angeles Alvarez Secord, MD, MHSc — Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Foundation Medicine, Genmab US Inc, Gilead Sciences Inc, GSK, HistoSonics, Medtronic Inc, Merck; Clinical Trial Steering Committees: Genmab US Inc, OncoQuest Inc; Consulting Agreements: GSK, Merck; Contracted Research: AbbVie Inc, Aravive Inc, AstraZeneca Pharmaceuticals LP, Canaria Bio Inc, Daiichi Sankyo Inc, Ellipses Pharma, Genentech, a member of the Roche Group, Genmab US Inc, GSK, ImmunoGen Inc, Karyopharm Therapeutics, Merck, Mersana Therapeutics Inc, Myriad Genetic Laboratories Inc, OncoQuest Inc, TORL BioTherapeutics, Zentalis Pharmaceuticals; Stock Options/Stock — Public Companies: Stock in Amgen Inc and Johnson & Johnson, divested in June 2024.

MODERATOR
Shannon N Westin, MD, MPH, FASCO, FACOG
Professor
Medical Director, Gynecologic Oncology Center
Director, Early Drug Development
Department of Gynecologic Oncology and Reproductive Medicine
The University of Texas MD Anderson Cancer Center
Houston, Texas

Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Caris Life Sciences, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Eisai Inc, Genentech, a member of the Roche Group, Genmab US Inc, Gilead Sciences Inc, GSK, Immunocore, ImmunoGen Inc, Incyte Corporation, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Mereo BioPharma, NGM Biopharmaceuticals, Nuvectis Pharma Inc, Ottimo Pharma, Pfizer Inc, pharmaand GmbH, PMV Pharma, Seagen Inc, Verastem Inc, Zentalis Pharmaceuticals, ZielBio; Contracted Research: AstraZeneca Pharmaceuticals LP, Avenge Bio, Bayer HealthCare Pharmaceuticals, Bio-Path Holdings Inc, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, GSK, Jazz Pharmaceuticals, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Mereo BioPharma, Novartis, Nuvectis Pharma Inc, pharmaand GmbH, Pfizer Inc, Verastem Inc, Zentalis Pharmaceuticals.

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.

This educational activity contains 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.

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Corcept Therapeutics Inc, and Merck.

Release date: May 2026
Expiration date: May 2027

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

Prof Colombo

Bradley W et al. Maintenance olaparib for patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation: 5-year follow-up from SOLO1. SGO 2021;Abstract 10520.

DiSilvestro P et al. Overall survival with maintenance olaparib at a 7-year follow-up in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation: The SOLO1/GOG 3004 trial. J Clin Oncol 2023;41(3):609-17. Abstract

González-Martín A et al. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med 2019;381(25):2391-402. Abstract

Harter P et al. Efficacy of maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed, advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial. Gynecol Oncol 2022;164(2):254-64. Abstract

Hettle R et al. Population-adjusted indirect treatment comparison of maintenance PARP inhibitor with or without bevacizumab versus bevacizumab alone in women with newly diagnosed advanced ovarian cancer. Ther Adv Med Oncol 2021:13:17588359211049639. Abstract

Konstantinopoulos PA et al. Homologous recombination deficiency: Exploiting the fundamental vulnerability of ovarian cancer. Cancer Discov 2015;5(11):1137-54. Abstract

Monk BJ et al. Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: Final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Ann Oncol 2024;35(11):981-92. Abstract

Monk BJ et al. A randomized, phase III trial to evaluate rucaparib monotherapy as maintenance treatment in patients with newly diagnosed ovarian cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45). J Clin Oncol 2022;40(34):3952-64. Abstract

O’Connor MJ. Targeting the DNA damage response in cancer. Mol Cell 2015;60(4):547-60. Abstract

Ray-Coquard I et al. Olaparib plus bevacizumab first-line maintenance in ovarian cancer: Final overall survival results from the PAOLA-1/ENGOT-ov25 trial. Ann Oncol 2023;34(8):681-92. Abstract

Ray-Coquard I et al. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med 2019;381(25):2416-28. Abstract

Saevets V et al. MONO-OLA1: A randomized, phase III study of olaparib maintenance monotherapy in patients with BRCA wild-type advanced ovarian cancer following response to first-line platinum-based chemotherapy. SGO 2022;Abstract 334.

Vergote I et al. Population-adjusted indirect treatment comparison of the SOLO1 and PAOLA-1/ENGOT-ov25 trials evaluating maintenance olaparib or bevacizumab or the combination of both in newly diagnosed, advanced BRCA-mutated ovarian cancer. Eur J Cancer 2021;157:415-23. Abstract

Dr Westin

Alvarez Secord A et al. The efficacy and safety of mirvetuximab soravtansine in FRα-positive, third-line and later, recurrent platinum-sensitive ovarian cancer: The single-arm phase II PICCOLO trial. Ann Oncol 2025;36(3):321-30. Abstract

Lee EK et al. A phase I/II study of rinatabart sesutecan (Rina-S) in patients with advanced ovarian or endometrial cancer. ESMO 2024;Abstract 719MO.

Matulonis UA et al. Efficacy and safety of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer with high folate receptor alpha expression: Results from the SORAYA study.J Clin Oncol 2023;41(13):2436-45. Abstract

Moore KN et al. Mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer. N Engl J Med 2023;389(23):2162-74. Abstract

Moore KN et al. Phase III MIRASOL (GOG 3045/ENGOT-ov55) study: Initial report of mirvetuximab soravtansine vs. investigator’s choice of chemotherapy in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. ASCO 2023;Abstract LBA5507. 

Oaknin A et al. Luveltamab tazevibulin (STRO-002), an anti-folate receptor alpha (FolRα) antibody drug conjugate (ADC), safety and efficacy in a broad distribution of FolRα expression in patients with recurrent epithelial ovarian cancer (OC): Update of STRO-002-GM1 phase 1 dose expansion cohort. ASCO 2023;Abstract 5508. 

O’Malley DM et al. Maintenance with mirvetuximab soravtansine plus bevacizumab vs bevacizumab in FRα-high platinum-sensitive ovarian cancer. Future Oncol 2024;20(32):2423-36. Abstract

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.

Shapira-Frommer R et al. Initial results from a first-in-human study of AZD5335, a folate receptor α (FRα)-targeted antibody-drug conjugate, in patients (pts) with platinum-resistant recurrent ovarian cancer (PRROC). ESMO 2024;Abstract 754P.

Dr Olawaiye

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. 

Olawaiye A et al. Final overall survival (OS) results from the phase 3 ROSELLA trial: Relacorilant plus nab-paclitaxel vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (PROC) (GOG-3073, ENGOT-ov72, APGOT-Ov10, and LACOG-0223). SGO 2026;Abstract S451. 

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. 

Olawaiye AB et al. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): An open-label, randomised, controlled, phase 3 trial. Lancet 2025;405(10496):P2205-16. Abstract

Dr Konecny

Tsao L-C et al. Effective extracellular payload release and immunomodulatory interactions govern the therapeutic effect of trastuzumab deruxtecan (T-DXd). Nat Commun 2025;16(1):3167. Abstract

Wei Q et al. Perivascular niche-resident alveolar macrophages promote interstitial pneumonitis related to trastuzumab deruxtecan treatment. Cancer Res 2025; 85(11):2081-99. Abstract

Faculty

TARGET AUDIENCE
This program is intended for gynecologic oncologists, medical oncologists, gynecologists and other healthcare providers involved in the treatment of endometrial cancer.

LEARNING OBJECTIVES

• Assess the clinical and biological characteristics of the various histologic subtypes and molecular subgroups of endometrial cancer, and consider the implications for prognosis and therapeutic decision-making.
• Evaluate the importance of microsatellite instability (MSI) and mismatch repair (MMR) deficiency assessment in the management of endometrial cancer, and adapt current testing practices to optimally identify patients with corresponding genetic abnormalities.
• Appreciate available clinical research findings with anti-PD-1/PD-L1 antibodies in combination with chemotherapy as first-line treatment for advanced or recurrent endometrial cancer, and educate patients with MSI-high/MMR-deficient or microsatellite-stable/MMR-proficient disease about this novel strategy.
• Understand the biological rationale for and available data with PARP inhibitors in combination with immune checkpoint inhibitor therapy for advanced or metastatic endometrial cancer.
• Recognize available data with anti-PD-1/PD-L1 antibodies in combination with agents targeting the VEGF pathway, and select patients with metastatic endometrial cancer for this novel approach.
• Recognize adverse events associated with immune checkpoint inhibitor-based approaches used in the treatment of endometrial cancer, in order to educate patients and manage complications.

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
Research To Practice designates this enduring material for a maximum of 1.75 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 this CME activity, which includes participation in the evaluation component and post-test, enables the participant to earn up to 1.75 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 this 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, this program has been specifically designed for the following ABIM specialty: medical oncology. 

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and post-test, 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, this program has 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/SGO26Endometrial/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:

Floor J Backes, MD
Professor
Larry J Copeland Professorship in Gynecologic Oncology
Director of Clinical Research
Associate Fellowship Director
Division of Gynecologic Oncology
Department of Obstetrics and Gynecology
The Ohio State University College of Medicine
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio

Advisory Committees and Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Eisai Inc, Genmab US Inc, GSK, ImmunoGen Inc, Merck, Tubulis; Contracted Research: ImmunoGen Inc, Merck, Natera Inc; Data and Safety Monitoring Boards/Committees: MacroGenics Inc.

Matthew A Powell, MD
Ira C and Judith Gall Professor
Division of Gynecologic Oncology
Chair, Uterine Corpus Committee
National Cancer Institute-Sponsored NRG Oncology
Washington University School of Medicine
St Louis, Missouri

Consulting Agreements: Eisai Inc, GSK, Merck; Contracted Research: GSK.

CONSULTING CLINICAL INVESTIGATORS — Professor Jonathan A Ledermann, MD — Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Flindr, GSK, ImmunoGen Inc, MSD, Novocure Inc; Consulting Agreements: AbbVie Inc, GSK; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Sutro Biopharma, Zentalis Pharmaceuticals; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, GSK, Medison Pharmaceuticals, MSD.  Ursula Matulonis, MD — Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Day One Biopharmaceuticals, GSK, NextCure, Novartis, Tango Therapeutics; Consulting Agreements: Whitehawk Therapeutics; Data and Safety Monitoring Boards/Committees: Daiichi Sankyo Inc, MacroGenics Inc, Mural Oncology Inc, Symphogen A/S.  Angeles Alvarez Secord, MD, MHSc — Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Foundation Medicine, Genmab US Inc, Gilead Sciences Inc, GSK, HistoSonics, Medtronic Inc, Merck; Clinical Trial Steering Committees: Genmab US Inc, OncoQuest Inc; Consulting Agreements: GSK, Merck; Contracted Research: AbbVie Inc, Aravive Inc, AstraZeneca Pharmaceuticals LP, Canaria Bio Inc, Daiichi Sankyo Inc, Ellipses Pharma, Genentech, a member of the Roche Group, Genmab US Inc, GSK, ImmunoGen Inc, Karyopharm Therapeutics, Merck, Mersana Therapeutics Inc, Myriad Genetic Laboratories Inc, OncoQuest Inc, TORL BioTherapeutics, Zentalis Pharmaceuticals; Stock Options/Stock — Public Companies: Stock in Amgen Inc and Johnson & Johnson, divested in June 2024.

MODERATOR
Ritu Salani, MD, MBA
Director, Division of Gynecologic Oncology
Professor, Department of Obstetrics and Gynecology
David Geffen School of Medicine at UCLA
Los Angeles, California

Advisory Committees: AbbVie Inc, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Eisai Inc, Genmab US Inc, GSK, Merck, Pfizer Inc, Whitehawk Therapeutics; Nonrelevant Financial Relationships: UpToDate.

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.

This educational activity contains 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 GSK.

Release date: May 2026
Expiration date: May 2027

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

Dr Backes

Erickson BK et al. Human epidermal growth factor 2 (HER2) in early stage uterine serous carcinoma: A multi-institutional cohort study. Gynecol Oncol 2020;159(1):17-22. Abstract

Erickson BK et al. Targeting human epidermal growth factor receptor 2 (HER2) in gynecologic malignancies. Curr Opin Obstet Gynecol 2020;32(1):57-64. Abstract

Eskander RN et al. Pembrolizumab plus chemotherapy in advanced or recurrent endometrial cancer: Overall survival and exploratory analyses of the NRG GY018 phase 3 randomized trial. Nat Med 2025;31(5):1539-46. Abstract

Halaska MJ et al. Pembrolizumab or placebo plus adjuvant chemotherapy with or without radiotherapy in patients with newly diagnosed, high-risk endometrial cancer: Exploratory analysis of disease-specific survival from the phase 3 ENGOT-En11/GOG-3053/KEYNOTE-B21 study. ESGO 2025;Abstract.

Howitt BE et al. Association of polymerase e-mutated and microsatellite-instable endometrial cancers with neoantigen load, number of tumor-infiltrating lymphocytes, and expression of PD-1 and PD-L1. JAMA Oncol 2015;1(9):1319-23. Abstract

Levine DA, on behalf of The Cancer Genome Atlas Research Network. Integrated genomic characterization of endometrial carcinoma. Nature 2013;497(7447):67-73. Abstract

Mirza MR et al. Dostarlimab+chemotherapy for the treatment of primary advanced or recurrent (A/R) endometrial cancer (EC): A placebo (PBO)-controlled randomised phase III trial (ENGOT-EN6-NSGO/GOG-3031/RUBY). ESMO 2023;Abstract VP2-2023.

Pignata S et al. MITO END-3: Efficacy of avelumab immunotherapy according to molecular profiling in first-line endometrial cancer therapy. Ann Oncol 2024;35(7):667-76. Abstract

Van Gorp T et al. ENGOT-en11/GOG-3053/KEYNOTE-B21: A randomised, double-blind, phase III study of pembrolizumab or placebo plus adjuvant chemotherapy with or without radiotherapy in patients with newly diagnosed, high-risk endometrial cancer. Ann Oncol 2024;35(11):968-80. Abstract

Westin SN et al. Biomarker heterogeneity and efficacy of durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib in patients with mismatch repair proficient endometrial cancer: Exploratory analyses of the DUO-E/GOG-3041/ENGOT-EN10 trial. Gynecol Oncol 2026;206:54-64. Abstract

Westin SN et al. Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer: Longitudinal changes in circulating tumor DNA. ASCO 2025;Abstract 5512.

Yen T-T et al. Molecular classification and emerging targeted therapy in endometrial cancer. Int J Gynecol Pathol 2020;39(1):26-35. Abstract

Dr Powell

Eskander RN et al. Pembrolizumab plus chemotherapy in advanced or recurrent endometrial cancer: Overall survival and exploratory analyses of the NRG GY018 phase 3 randomized trial. Nat Med 2025;31(5):1539-46. Abstract

Eskander RN et al. Pembrolizumab plus chemotherapy in advanced endometrial cancer. N Engl J Med 2023;388(23):2159-70. Abstract

Miller DS et al. Carboplatin and paclitaxel for advanced endometrial cancer: Final overall survival and adverse event analysis of a phase III trial (NRG Oncology/GOG0209). J Clin Oncol 2020;38(33):3841-50. Abstract

Mirza M et al. Dostarlimab in combination with chemotherapy for the treatment of primary advanced or recurrent endometrial cancer: A placebo-controlled randomized phase 3 trial (ENGOT-EN6-NSGO/GOG-3031/RUBY). SGO 2023;Abstract LBA 11.

Moore K et al. Durvalumab plus carboplatin/paclitaxel followed by durvalumab with/without olaparib in endometrial cancer: Biomarkers, histological heterogeneity, baseline circulating tumor DNA and efficacy in the DUO-E mismatch repair proficient subpopulation. SGO 2025;Abstract.

Powell M et al. Overall survival among patients with primary advanced or recurrent endometrial cancer treated with dostarlimab plus chemotherapy in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial. SGO 2024;Abstract.

Van Gorp T et al. ENGOT-en11/GOG-3053/KEYNOTE-B21: A randomised, double-blind, phase III study of pembrolizumab or placebo plus adjuvant chemotherapy with or without radiotherapy in patients with newly diagnosed, high-risk endometrial cancer. ESMO 2024;Abstract LBA28.

Westin SN et al. Durvalumab plus carboplatin/paclitaxel followed by maintenance durvalumab with or without olaparib as first-line treatment for advanced endometrial cancer: The phase III DUO-E trial. J Clin Oncol 2024;42(3):283-99. Abstract

Westin SN et al. Durvalumab (durva) plus carboplatin/paclitaxel (CP) followed by maintenance (mtx) durva ± olaparib (ola) as a first-line (1L) treatment for newly diagnosed advanced or recurrent endometrial cancer (EC): Results from the phase III DUO-E/GOG-3041/ENGOT-EN10 trial. ESMO 2023;Abstract LBA41.

Dr Salani

Baurain J-F et al. Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as a firstline treatment for endometrial cancer: Overall survival and additional secondary efficacy endpoints by mismatch repair status in the DUO-E/GOG-3041/ENGOT-EN10 trial. SGO 2024;Abstract.

Konstantinopoulos PA. Evaluation of treatment with talazoparib and avelumab in patients with recurrent mismatch repair proficient endometrial cancer. JAMA Oncol 2022;8(9):1317-22. Abstract

Leslie KK et al. Mutated p53 portends improvement in outcomes when bevacizumab is combined with chemotherapy in advanced/recurrent endometrial cancer: An NRG Oncology study. Gynecol Oncol 2021;161(1):113-21. Abstract

Makker V et al. Lenvatinib plus pembrolizumab in previously treated advanced endometrial cancer: Updated efficacy and safety from the randomized phase III study 309/KEYNOTE-775. J Clin Oncol 2023;41(16):2904-10. Abstract

Mirza MR et al. Dostarlimab for primary advanced or recurrent endometrial cancer. N Engl J Med 2023;388(23):2145-58. Abstract

Post CCB et al. Efficacy and safety of durvalumab with olaparib in metastatic or recurrent endometrial cancer (phase II DOMEC trial). Gynecol Oncol 2022;165(2):223-9. Abstract

Powell M et al. Chemotherapy with or without pembrolizumab followed by maintenance with olaparib or placebo for first-line treatment of advanced BRCA nonmutated epithelial ovarian cancer: Results from the randomized phase III ENGOT-OV43/GOG-3036/KEYLYNK-001 study. SGO 2025;Abstract.

Thiel KW et al. TP53 sequencing and p53 immunohistochemistry predict outcomes when bevacizumab is added to frontline chemotherapy in endometrial cancer: An NRG oncology/gynecologic oncology group study. J Clin Oncol 2022;40(28):3289-300. Abstract

Faculty

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

LEARNING OBJECTIVES

• Understand the incidence and prognostic and clinical relevance of microsatellite instability (MSI)/mismatch repair (MMR) deficiency in patients with localized colorectal cancer (CRC), and consider the implications for molecular testing and care.
• Evaluate the biological rationale for the use of immune checkpoint inhibitors in the care of patients with localized MSI-high (MSI-H)/MMR-deficient (dMMR) CRC, and provide counsel regarding available clinical evidence and guideline-endorsed treatment recommendations.
• Optimize the current and future use of neoadjuvant therapy for patients with localized and locally advanced CRC, considering the influence of various clinical and biological factors, including MSI/MMR status.
• Appreciate published research documenting the efficacy and safety of anti-PD-1/PD-L1 antibody therapy added to standard adjuvant chemotherapy for Stage III MSI-H/dMMR colon cancer, and counsel patients regarding the potential role of this novel therapeutic approach.
• Recognize the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in CRC, and comprehend the rationale for its use in detecting molecular residual disease in patients.
• Appreciate published datasets documenting the clinical utility of ctDNA testing in risk stratification, surveillance and treatment decision-making for patients with CRC, and consider the current and future role of this strategy in personalizing treatment.
• Recall ongoing trials evaluating novel agents and strategies for patients with nonmetastatic CRC, and use this information to refer candidates 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 Proceedings: Research To Practice designates this enduring material for a maximum of 1.75 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 1.75 (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
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/ASCOGI26/LocalizedCRC/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 these activities. 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:

Stacey A Cohen, MD
Professor
Fred Hutchinson Cancer Center
University of Washington
Seattle, Washington

Advisory Committees: AbbVie Inc, Agenus Inc, Caris Life Sciences, DoMore Diagnostics, Exact Sciences Corporation, Guardant Health, Incyte Corporation, Janssen Biotech Inc, Merck, Pfizer Inc, Roche Laboratories Inc; Data and Safety Monitoring Boards/Committees: GSK.

Jenny Seligmann, MBChB, PhD
Professor of Gastrointestinal Cancer
University of Leeds
Leeds, United Kingdom

No relevant financial relationships to disclose.

MODERATOR
Christopher Lieu, MD
Professor of Medicine
Associate Director for Clinical Research
Director, GI Medical Oncology
University of Colorado Cancer Center
Aurora, Colorado

Consulting Agreements (to Institution): Pfizer Inc; Contracted Research (All to Institution): Genentech, a member of the Roche Group, Janssen Biotech Inc, Sanofi.

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 Genentech, a member of the Roche Group, GSK, and Natera Inc.

Release date: February 2026
Expiration date: February 2027

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

Dr Seligmann

André T et al. Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): A randomised, open-label, phase 3 trial. Lancet 2025;405(10476):383-95. Abstract

Cercek A et al. A phase two, single-arm, open-label study with dostarlimab monotherapy in participants with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (AZUR-1). Clin Colorectal Cancer 2025;24(2):325-30. Abstract

Cercek A et al. Nonoperative management of mismatch repair-deficient tumors. N Engl J Med 2025;392(23):2297-308. Abstract

Chalabi M et al. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med 2020;26(4):566-76. Abstract

Kasi PM et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study. Gastrointestinal Cancers Symposium 2024;Abstract 9.

Morton D et al. Preoperative chemotherapy for operable colon cancer: Mature results of an international randomized controlled trial. J Clin Oncol 2023;41(8):1541-52. Abstract

Ochiai K et al. Total neoadjuvant therapy for rectal cancer: Which regimens to use? Cancers (Basel) 2024;16(11):2093. Abstract

Sassun R et al. Oncological outcomes of neoadjuvant chemotherapy versus upfront surgery in locally advanced colon cancer: A systematic review, meta-analysis, and sequential analysis. Ann Surg Oncol 2025;32(9):6720-7. Abstract

Seligmann J et al. Comparison of outcomes in clinical trials of locally advanced dMMR colon cancer: FOxTROT and NICHE-2. ESMO 2025;Abstract 724O.

Dr Lieu

André T et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol 2009;27(19):3109-16. Abstract

Courneya KS et al. Structured exercise after adjuvant chemotherapy for colon cancer. N Engl J Med 2025;393(1):13-25. Abstract

Martling A et al. Low-dose aspirin for PI3K-altered localized colorectal cancer. N Engl J Med 2025;393(11):1051-64. Abstract

Rasschaert G et al. AZUR-4, a phase 2, open label, randomized study of neoadjuvant dostarlimab plus capecitabine plus oxaliplatin (CAPEOX) versus CAPEOX alone in previously untreated T4N0 or stage III mismatch repair proficient/microsatellite stable resectable colon cancer. ASCO 2025;Abstract TPS3649.

Sargent DJ et al. Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer. J Clin Oncol 2010;28(20):3219-26. Abstract

Sinicrope FA et al. Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502; ATOMIC). ASCO 2025;Abstract LBA1.

Dr Cohen

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.

Cohen SA et al. Practical recommendations for using ctDNA in clinical decision making. Nature 2023;619(7969):259-68. Abstract

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

Dasari A et al. Subgroup analyses of safety and efficacy by number and types of prior lines of treatment in FRESCO-2, a global phase III study of fruquintinib in patients with refractory metastatic colorectal cancer. ASCO 2023;Abstract 3604.

Dasari A et al. ctDNA applications and integration in colorectal cancer: An NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol 2020;17(12):757-70. Abstract

Gianni C et al. Cell-free DNA fragmentomics: A promising biomarker for diagnosis, prognosis and prediction of response in breast cancer. Int J Mol Sci 2022;23(22):14197. Abstract

Kasi PM et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study. Gastrointestinal Cancers Symposium 2024;Abstract 9.

Kotaka M et al. Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patients with colorectal cancer from an observational GALAXY study in CIRCULATE-Japan. Gastrointestinal Cancers Symposium 2022;Abstract 9.

Maddalena G et al. INTERCEPT Program of circulating tumor DNA (ctDNA) testing for minimal residual disease (MRD) in colorectal cancer (CRC): Results from a prospective clinical cohort. Gastrointestinal Cancers Symposium 2024;Abstract 27.

Morris VK et al. Phase II results of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA) phase II/III study. Gastrointestinal Cancers Symposium 2024;Abstract 5.

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

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

Parikh AR et al. Minimal residual disease detection using a plasma-only circulating tumor DNA assay in patients with colorectal cancer. Clin Cancer Res 2021;27(20):5586-94. Abstract

Rolfo C, Russo A. Liquid biopsy for early stage lung cancer moves ever closer. Nat Rev Clin Oncol 2020;17(9):523-4. Abstract

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: 5-year outcomes of the randomized DYNAMIC trial. Nat Med 2025;31(5):1509-18. Abstract

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;31(12):4291-300. Abstract

Tie J et al. ctDNA-guided adjuvant chemotherapy escalation in stage III colon cancer: Primary analysis of the ctDNA-positive cohort from the randomized AGITG dynamic-III trial (intergroup study of AGITG and CCTG). ASCO 2025;Abstract 3503.

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.

Zhang GQ et al. Predictive role of circulating tumor DNA in stage III colon cancer treated with celecoxib: A post hoc analysis of the CALGB (Alliance)/SWOG 80702 phase 3 randomized clinical trial. JAMA Oncol 2025:e255144. Abstract

Faculty

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

LEARNING OBJECTIVES

• Describe published research data with immune checkpoint inhibitors alone or in combination with other systemic therapies in the management of metastatic gastric, gastroesophageal junction (GEJ) and esophageal cancers, and optimally integrate these strategies into nonresearch treatment algorithms.
• Assess available data with monoclonal antibody therapy directed at claudin 18.2 (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 and emerging research findings with HER2-targeted therapies for patients with HER2-positive gastroesophageal cancers, and assess the current and future role of various agents and regimens.
• Evaluate the scientific justification for the dual targeting of PD-1 and TIGIT for patients with gastroesophageal cancers, and appreciate available data with this novel approach.
• Appreciate the rationale for, available data with and ongoing research studies evaluating novel targeted and immunotherapeutic strategies for gastroesophageal cancers to enhance clinical trial participation for appropriately identified patients.

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 Proceedings: 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) — 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/ASCOGI26/ImmunoTargetedGE/Video/CME. The corresponding audio program is available as an alternative at ResearchToPractice.com/ASCOGI26/ImmunoTargetedGE.

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 these activities. 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:

Jaffer A Ajani, MD
Professor of Medicine
Department of Gastrointestinal Medical Oncology
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, Texas

Advisory Committees and Consulting Agreements: AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Daiichi Sankyo Inc, Gilead Sciences Inc, Henlius, Jazz Pharmaceuticals Inc, Merck, Taiho Oncology Inc, Zymeworks Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Henlius, I-Mab Biopharma, Jazz Pharmaceuticals Inc, Merck, Servier Pharmaceuticals LLC.

Rutika Mehta, MD, MPH
Associate Professor, Division of Hematology/Oncology
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York

Advisory Committees: Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Daiichi Sankyo Inc, Eisai Inc, Gilead Sciences Inc, GSK, Jazz Pharmaceuticals Inc, Legend Biotech; Consulting Agreements: Jazz Pharmaceuticals Inc, Lilly, Replimune; Data and Safety Monitoring Boards/Committees: Arcus Biosciences, Gilead Sciences Inc; Nonrelevant Financial Relationships: Robert A Winn Career Development Award.

John Strickler, MD
Professor of Medicine
Associate Director, Clinical Research – GI
Co-Leader, Molecular Tumor Board
Duke University
Durham, North Carolina

Advisory Committees: AbbVie Inc, Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeOne, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Cytovation ASA, Daiichi Sankyo Inc, GE Healthcare, Genentech, a member of the Roche Group, GSK, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Leap Therapeutics Inc, Lilly, Merck, Natera Inc, Pfizer Inc, Pheon Therapeutics, Quanta Therapeutics, Regeneron Pharmaceuticals Inc, Sanofi, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, Triumvira Immunologics, Xilio Therapeutics; Contracted Research: AbbVie Inc, Amgen Inc, Apollo Therapeutics, Bayer HealthCare Pharmaceuticals, BeOne, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, GSK, Leap Therapeutics Inc, Lilly, Novartis, Pfizer Inc, Quanta Therapeutics, Revolution Medicines; Data and Safety Monitoring Boards/Committees: AbbVie Inc, Johnson & Johnson; Stock Options — Private Companies: Triumvira Immunologics.

MODERATOR
Samuel J Klempner, MD
Program Director, Gastroesophageal Cancers
Tobins Family Endowed Chair in Esophagogastric Cancer
Massachusetts General Hospital
Associate Professor, Harvard Medical School
Boston, Massachusetts

Advisory Committees: Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology, Gilead Sciences Inc, I-Mab Biopharma, Merck, Mersana Therapeutics Inc, Natera Inc, Novartis, Pfizer Inc, Taiho Oncology Inc; Consulting Agreements: Astellas, Novartis (ended 2023); Stock Options — Private Companies: MBrace Therapeutics; Nonrelevant Financial Relationships: Debbie’s Dream Foundation, Degregorio Family Foundation, Gastric Cancer Foundation, Gateway for Cancer Research, National Cancer Institute/National Institutes of Health, NCCN (member of Gastric and Esophageal Guidelines Committees), Stand Up 2 Cancer/AACR, Torrey Coast Foundation.

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 Astellas, BeOne, Gilead Sciences Inc, and Jazz Pharmaceuticals 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 Ajani

Elimova E et al. Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. Gastrointestinal Cancers Symposium 2026;Abstract LBA285.

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

Meric-Bernstam F et al. Zanidatamab monotherapy or combined with chemotherapy in HER2-expressing gastroesophageal adenocarcinoma: A phase 1 trial. Nat Commun 2025;16(1):4293. Abstract

Shitara K et al. Trastuzumab deruxtecan or ramucirumab plus paclitaxel in gastric cancer. N Engl J Med 2025;393(4):336-48. Abstract

Dr Strickler

Ajani JA et al. Gastric cancer, version 2.2025, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw 2025;23(5):169-91. Abstract

Bray F et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2024;74(3):229-63. Abstract

Kubota Y et al. Comprehensive clinical and molecular characterization of claudin 18.2 expression in advanced gastric or gastroesophageal junction cancer. ESMO Open 2023;8(1):100762. Abstract

Shah MA et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: The randomized, phase 3 GLOW trial. Nat Med 2023;29(8):2133-41. Abstract

Shitara K et al. Phase 2 ILUSTRO trial of 1L zolbetuximab plus mFOLFOX6 and nivolumab in patients with CLDN18.2+ locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. Gastrointestinal Cancers Symposium 2026;Abstract LBA284.

Shitara K et al. Zolbetuximab in gastric or gastroesophageal junction adenocarcinoma. N Engl J Med 2024;391(12):1159-62. Abstract

Shitara K et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): A multicentre, randomised, double-blind, phase 3 trial. Lancet 2023;401(10389):1655-68. Abstract

Dr Mehta

Janjigian YY et al. First-line nivolumab plus chemotherapy for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: 3-year follow-up of the phase III CheckMate 649 trial. J Clin Oncol 2024;42(17):2012-20. Abstract

Janjigian YY et al. Pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma: Interim analyses from the phase 3 KEYNOTE-811 randomised placebo-controlled trial. Lancet 2023;402(10418):2197-208. Abstract

Janjigian YY et al. Pembrolizumab plus trastuzumab and chemotherapy for HER2+ metastatic gastric or gastroesophageal junction (G/GEJ) cancer: Initial findings of the global phase 3 KEYNOTE-811 study. ASCO 2021;Abstract 4013.

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.

Qi C et al. Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician’s choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01). ASCO 2025;Abstract 4003.

Qiu M et al. Tislelizumab (TIS) + chemotherapy (chemo) vs placebo (PBO) + chemo as first-line (1L) treatment in gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) patients with/without peritoneal or liver metastases: A post hoc analysis of RATIONALE-305 study. Gastrointestinal Cancers Symposium 2025;Abstract 414.

Qiu MZ et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ 2024;385:e078876. Abstract

Rha SY et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): A multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol 2023;24(11):1181-95. Abstract

Shah MA et al. Phase II study of telomelysin (OBP-301) in combination with pembrolizumab in gastroesophageal (GEA) adenocarcinoma. ASCO 2023;Abstract 4052.

Dr Klempner

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. Domvanalimab and zimberelimab in advanced gastric, gastroesophageal junction or esophageal cancer: A phase 2 trial. Nat Med 2025;31(12):4274-80. Abstract

Liu JJ et al. Anti-claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients (pts) with solid tumors and gastric/gastro-esophageal junction adenocarcinoma (G/GEJ AC): A phase I study. ESMO GI 2024;Abstract 396MO.

Rivera Herrero F et al. First-line rilvegostomig (rilve) + chemotherapy (CTx) in patients (pts) with HER2-negative (HER2–) locally advanced unresectable or metastatic gastric cancers: First report of GEMINI-Gastric sub study 2. ESMO 2024;Abstract 1422P.

Shitara K et al. Global prevalence of claudin 18 isoform 2 in tumors of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Gastric Cancer 2024;27(5):1058-68. Abstract

Xu R-H et al. CLDN18.2 targeted antibody-drug conjugate (ADC), SHR-A1904, in patients (pts) with gastric/gastroesophageal junction cancer (GC/GEJC): A phase I study. ESMO 2024;Abstract 609O.

Faculty

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

LEARNING OBJECTIVES

• Appreciate the prevalence and clinical relevance of human epidermal growth factor receptor 2 (HER2) amplification or overexpression in various GI cancers, and consider the implications for biomarker assessment and clinical management.
• Evaluate published clinical trial findings with HER2-directed therapies for HER2-positive biliary tract cancers, and optimally incorporate available agents into the clinical care of appropriately selected patients.
• Review published and emerging research findings with HER2-targeted therapies for patients with HER2-positive gastroesophageal cancers, and assess the current and future role of various agents and regimens.
• Recall available data with HER2-targeted agents and strategies for patients with previously treated HER2-overexpressing colorectal cancer, and optimally identify candidates who may be appropriate for these approaches.
• Appraise the side effects associated with HER2-directed therapies with established efficacy in GI cancers, and use this information to develop supportive management plans for patients.
• Recall the design of ongoing clinical trials evaluating novel HER2-directed strategies for HER2-positive GI cancers, and counsel appropriately selected 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 Proceedings: Research To Practice designates this enduring material for a maximum of 1.75 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 1.75 (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 component and a post-test, 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/ASCOGI26/HER2PosGI/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 these activities. 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:

Haley Ellis, MD
Medical Oncologist
Massachusetts General Hospital
Instructor of Medicine
Harvard Medical School
Boston, Massachusetts

Advisory Committees: AstraZeneca Pharmaceuticals LP, Cogent Biosciences, Jazz Pharmaceuticals Inc; Honoraria: Incyte Corporation, Jazz Pharmaceuticals Inc; Nonrelevant Financial Relationships: Medscape, OncLive, The Jackson Laboratory.

Eric Van Cutsem, MD, PhD
Professor of Medicine
Digestive Oncology
University Hospitals Leuven
Leuven, Belgium

Consulting Agreements: AbbVie Inc, Agenus Inc, ALX Oncology, Amgen Inc, Arcus Biosciences, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeOne, BioNTech SE, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Cantargia, Daiichi Sankyo Inc, Debiopharm, Eisai Inc, ElmediX, Fosun Pharma, Galapagos NV, GSK, Incyte Corporation, Ipsen Biopharmaceuticals Inc, iTeos Therapeutics, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Merck KGaA, Microbial Machines, Mirati Therapeutics Inc, MSD, Nordic Pharma, Novartis, Novocure Inc, Pfizer Inc, Pierre Fabre, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, Simcere, Taiho Oncology Inc, Takeda Pharmaceutical Company Limited, Trishula Therapeutics, Zymeworks Inc.

Zev Wainberg, MD, MSc
Co-Director, GI Oncology Program
Director of Early Phase Clinical Research
Jonsson Comprehensive Cancer Center
UCLA School of Medicine
Los Angeles, California

Consulting Agreements: AbbVie Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Daiichi Sankyo Inc, EMD Serono Inc, Gilead Sciences Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Lilly, Merck, Novartis, Novocure Inc, Pfizer Inc, Regeneron Pharmaceuticals Inc, Takeda Pharmaceuticals USA Inc; Contracted Research: Arcus Biosciences, Bristol Myers Squibb; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP, Pfizer Inc.

MODERATOR
Lionel A Kankeu Fonkoua, MD
Senior Associate Consultant
Assistant Professor of Oncology Division of Medical Oncology, GI Cancer Program
Mayo Clinic
Rochester, Minnesota

No relevant conflicts of interest to disclose.

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 AstraZeneca Pharmaceuticals LP and Daiichi Sankyo 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 Ellis

Ayasun R et al. The role of HER2 status in the biliary tract cancers. Cancers (Basel) 2023;15(9):2628. Abstract

Bartley AN et al. HER2 testing and clinical decision making in gastroesophageal adenocarcinoma: Guideline from the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. J Clin Oncol 2017;35(4):446-44. Abstract

Harding JJ et al. Landmark analysis of overall survival (OS) by objective response in patients (pts) with previously treated, advanced HER2-positive biliary tract cancer (BTC): Post hoc analysis of the HERIZON-BTC-01 trial. Gastrointestinal Cancers Symposium 2026;Abstract 545.

Harding JJ et al. HERIZON-BTC-302: A phase 3 study of zanidatamab with standard-of-care (SOC) therapy vs SOC alone for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced/metastatic biliary tract cancer (BTC). Gastrointestinal Cancers Symposium 2025;Abstract TPS648.

Ikeda M et al. Randomized, open-label, multicenter, phase III study of trastuzumab deruxtecan (T-DXd) with rilvegostomig vs standard of care (SOC) in first-line, human epidermal growth factor receptor 2 (HER2)-expressing, locally advanced or metastatic (LA/m) biliary tract cancer (BTC): DESTINY-BTC01. ESMO 2024;Abstract 261TiP.

Inoue K et al. Clinicomolecular profile and efficacy of human epidermal growth factor receptor 2 (HER2)-targeted therapy for HER2-amplified advanced biliary tract cancer. JCO Precis Oncol 2025:e2400718. Abstract

Kehmann L et al. Evolving therapeutic landscape of advanced biliary tract cancer: From chemotherapy to molecular targets. ESMO Open 2024;9(10):103706. Abstract

Lamarca A et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): A phase 3, open-label, randomised, controlled trial. Lancet Oncol 2021;22(5):690-701. Abstract

Lee C et al. Impact of HER2-positivity on prognosis and targeted therapeutic outcomes in advanced biliary tract cancer. Gastrointestinal Cancers Symposium 2025;Abstract 629.

Meric-Bernstam F et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial. J Clin Oncol 2024;42(1):47-58. Abstract

Oh D-Y et al. Durvalumab plus chemotherapy in advanced biliary tract cancer: 3-year overall survival update from the phase III TOPAZ-1 study. J Hepatol 2025;83(5):1092-101. Abstract

Ohba A et al. Trastuzumab deruxtecan in human epidermal growth factor receptor 2–expressing biliary tract cancer (HERB; NCCH1805): A multicenter, single-arm, phase II trial. J Clin Oncol 2024;42(27):3207-17. Abstract

Pant S et al. Zanidatamab in HER2-positive metastatic biliary tract cancer: Final results from HERIZON-BTC-01. JAMA Oncol 2025;12(1):106-9. Abstract

Søreide K et al. Biliary tract cancer. Eur J Surg Oncol 2025;51(6):108489. Abstract

Dr Wainberg

Cammarota A et al. Targeting HER2 in gastroesophageal cancer: A new appetite for an old plight. Drugs 2025;85(3):361-83. Abstract

Elimova E et al. Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. Gastrointestinal Cancer Symposium 2026;Abstract LBA285.

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

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. Trastuzumab deruxtecan (T-DXd) monotherapy and combinations in patients (pts) with advanced/metastatic HER2-positive (HER2+) esophageal, gastric or gastroesophageal junction adenocarcinoma (GEJA): DESTINY-Gastric03 (DG-03). ESMO 2024;Abstract 1401O.

Jubashi A et al. Prognostic and predictive factors for the efficacy and safety of trastuzumab deruxtecan in HER2-positive gastric or gastroesophageal junction cancer. Gastric Cancer 2025;28(1):63-73. Abstract

Klempner et al. ERBB2 copy number (CN) as a quantitative biomarker for real-world (RW) outcomes to anti-HER2 therapy in advanced gastroesophageal adenocarcinoma (adv GEA). ASCO 2021;Abstract 4045.

Shitara K et al. An open-label, randomized, multicenter, phase 3 study of trastuzumab deruxtecan (T-DXd) + chemotherapy (chemo) ± pembrolizumab (pembro) versus chemo + trastuzumab ± pembro in first-line metastatic HER2+ gastric or gastroesophageal junction (GEJ) cancer: DESTINY-Gastric05. ASCO 2025;Abstract TPS4207.

Shitara K et al. Trastuzumab deruxtecan or ramucirumab plus paclitaxel in gastric cancer. N Engl J Med 2025;393(4):336-48. Abstract

Shitara K et al. Trastuzumab deruxtecan in HER2-positive advanced gastric cancer: Exploratory biomarker analysis of the randomized, phase 2 DESTINY-Gastric01 trial. Nat Med 2024;30(7):1933-42. Abstract

Yamaguchi K et al. Trastuzumab deruxtecan in anti-human epidermal growth factor receptor 2 treatment-naive patients with human epidermal growth factor receptor 2-low gastric or gastroesophageal junction adenocarcinoma: Exploratory cohort results in a phase II trial. J Clin Oncol 2023;41(4):816-25. Abstract

Yang H et al. Oesophageal cancer. Lancet 2024;404(10466):1991-2005. Abstract

Prof Van Cutsem

Germani MM et al. Impact of human epidermal growth factor receptor 2 in patients with metastatic colorectal cancer treated with chemotherapy plus bevacizumab or anti-EGFRs: Exploratory analysis of eight randomized trials. J Clin Oncol 2025;43(29):3184-97. Abstract

Meric-Bernstam F et al. Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: A phase 1, dose-escalation and expansion study. Lancet Oncol 2022;23(12):1558-70. Abstract

Oh D-Y, Bang Y-J. HER2-targeted therapies – A role beyond breast cancer. Nat Rev Clin Oncol 2020;17(1):33-48. Abstract

Raghav K et al. Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): Primary results from a multicentre, randomised, phase 2 trial. Lancet Oncol 2024;25(9):1147-62. Abstract

Rha SY et al. Zanidatamab (Zani) + chemotherapy (CT) in first-line (1L) human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic colorectal cancer (mCRC). ESMO 2024;Abstract 516MO.

Sartore-Bianchi A et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): A proof-of-concept, multicentre, open-label, phase 2 trial. Lancet Oncol 2016;17(6):738-46. Abstract

Strickler JH et al. MOUNTAINEER-03 phase III study design: First-line mFOLFOX6 + tucatinib + trastuzumab for HER2+ metastatic colorectal cancer. Future Oncol 2025;21(3):303-11. Abstract

Strickler JH et al. Final results of a phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC (MOUNTAINEER). ASCO 2024;Abstract 3509.

Vaghi C et al. Targeting HER2 in metastatic colorectal cancer: Current therapies, biomarker refinement, and emerging strategies. Drugs 2026;86(1):37-57. Abstract

Yoshino T et al. Final results of DESTINY-CRC01 investigating trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer. Nat Commun 2023;14(1):3332. Abstract

Faculty

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

LEARNING OBJECTIVES

• Appreciate the incidence and clinical relevance of PTEN deficiency in prostate cancer, and develop an understanding of the optimal method to assess PTEN status in patients.
• Assess the clinical and biological factors in the selection of therapy for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in order to optimally personalize treatment recommendations.
• Evaluate available Phase III data with novel AKT inhibitors in combination with hormonal therapy for patients with mHSPC and PTEN deficiency, and consider the potential role of this form of treatment.
• Implement a plan of care to recognize and manage side effects and toxicities associated with AKT inhibitors in preparation for their potential availability for patients with prostate cancer.

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 Proceedings: Research To Practice designates this enduring material for a maximum of 1.75 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 1.75 (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) — 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/ASCOGU2026/AKTiProstate/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:

Karim Fizazi, MD, PhD
GETUG President
University of Paris Saclay
Centre Oscar Lambret
Lille, France

Honoraria, Former Institution: Advanced Accelerator Applications, Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Janssen Biotech Inc, Merck, MSD, Novartis, Pfizer Inc.

Daniel George, MD
Eleanor Easley Distinguished Chair
Professor of Medicine, Surgery and Urology
Duke University School of Medicine
ACS Research Professor
Co-Lead, DCI Center for Prostate and Urologic Cancers
Duke Cancer Institute
Durham, North Carolina

Advisory Committees: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Candel Therapeutics, Convergent Therapeutics Inc, Dendreon Pharmaceuticals LLC, Johnson & Johnson, Merck, Novartis, Pfizer Inc; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Eisai Inc, Johnson & Johnson, Novartis, Pfizer Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Exelixis Inc, Johnson & Johnson, Merck, Novartis, Pfizer Inc, pharmaand GmbH; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP; Stock Options/Stock — Public Companies: Bristol Myers Squibb, Pfizer Inc; Nonrelevant Financial Relationships: IDEOlogy Health, MJH Life Sciences, Onclive, Targeted Oncology.

CONSULTING CLINICAL INVESTIGATORS — Neeraj Agarwal, MD, FASCO
has no relevant financial relationships to disclose. The following faculty reported relevant financial relationships with ineligible entities:

Rana R McKay, MD, FASCO — Advisory Committees and Consulting Agreements: Ambrx, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Blue Earth Diagnostics, Boundless Bio, Bristol Myers Squibb, Calithera Biosciences, Caris Life Sciences, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, Exelixis Inc, Janssen Biotech Inc, Lilly, Merck, Myovant Sciences, Neomorph, Nimbus Therapeutics, Novartis, Pfizer Inc, Sanofi, Seagen Inc, Sorrento Therapeutics, Telix Pharmaceuticals Limited, Tempus; Contracted Research: Artera, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Exelixis Inc, Incyte Corporation, Natera Inc, Oncternal Therapeutics.

MODERATOR
Elisabeth I Heath, MD
Chair, Department of Oncology
Mayo Clinic
Rochester, Minnesota

Advisory Committees: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, EMD Serono Inc, Gilead Sciences Inc, Novartis, Petauri Kinect, Pfizer Inc, Sanofi, Seagen Inc, Sumitomo Pharma America; Advisory Committees (to Institution): Janssen Biotech Inc; Consulting Agreements (to Institution): Novartis; Contracted Research (Research Support to Institution): Altor Bioscience Corporation, Amgen Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BioXcel Therapeutics Inc, Bristol Myers Squibb, Calithera Biosciences, Caris Life Sciences, Clarity Pharmaceuticals, Corcept Therapeutics Inc, Corvus Pharmaceuticals, Daiichi Sankyo Inc, Eisai Inc, Exelixis Inc, F Hoffmann-La Roche Ltd, Fortis Therapeutics, Gilead Sciences Inc, GSK, Harpoon Therapeutics, Infinity Pharmaceuticals Inc, iTeos Therapeutics, Janssen Biotech Inc, Janux Therapeutics, Johnson & Johnson, MacroGenics Inc, Merck, Mirati Therapeutics Inc, Modra Pharmaceuticals, MSD, Novartis, Oncolys BioPharma, Peloton Therapeutics Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, POINT Biopharma, Regeneron Pharmaceuticals Inc, Seagen Inc, Xencor; Nonrelevant Financial Relationships (to Institution): Calibr-Skaggs Institute for Innovative Medicines.

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 AstraZeneca Pharmaceuticals LP.

Release date: March 2026
Expiration date: March 2027

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

Dr George

Kisiel F et al. Prognostic significance of PTEN loss in prostate cancer: A meta-analysis of Gleason grade and clinical outcomes. Cancers (Basel) 2025;17(17):2862. Abstract

Lotan TL et al. Analytic validation of a clinical-grade PTEN immunohistochemistry assay in prostate cancer by comparison with PTEN FISH. Mod Pathol 2016;29(8):904-14. Abstract

Maylin ZR et al. Therapeutic exploitation of neuroendocrine transdifferentiation drivers in prostate cancer. Cells 2024;13(23):1999. Abstract

Tortorella E et al. AR and PI3K/AKT in prostate cancer: A tale of two interconnected pathways. Int J Mol Sci 2023;24(3):2046. Abstract

Prof Fizazi

de Bono JS et al. Final overall survival and molecular data associated with clinical outcomes in patients receiving ipatasertib and abiraterone in the phase 3 IPATential150 trial. Eur Urol 2025;87(6):672-82. Abstract

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.

Sweeney C et al. Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): A multicentre, randomised, double-blind, phase 3 trial. Lancet 2021;398(10295):131-42. Abstract

Dr Heath

George DJ et al. Patient reported outcomes (PRO) and tolerability of capivasertib (capi) plus abiraterone (abi) versus placebo (pbo) plus abi in patients (pts) with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. Genitourinary Cancers Symposium 2026;Abstract 14.

Iyengar NM et al. Optimizing clinical monitoring and management guidelines for capivasertib in HR-positive/HER2-negative advanced breast cancer: Expert opinion. NPJ Breast Cancer 2025;12(1):16. Abstract

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.

LEARNING OBJECTIVES

• Appreciate the biological rationale for combining anti-PD-1/PD-L1 antibodies with bacillus Calmette-Guérin (BCG) for patients with non-muscle-invasive bladder cancer (NMIBC), and discuss available data with and the potential role of this novel approach.
• Optimize the management of high-risk NMIBC that is unresponsive to BCG, considering the efficacy and tolerability of FDA-endorsed therapies.
• Review available clinical trial evidence with novel intravesical therapies for NMIBC, and optimally incorporate these approaches into the care of appropriately selected patients.
• Analyze the biological basis for the use of perioperative immune checkpoint inhibitor therapy or perioperative immune checkpoint inhibitor therapy in combination with antibody-drug conjugate therapy for patients with muscle-invasive bladder cancer (MIBC), and evaluate available and emerging data documenting the efficacy and safety of these strategies.
• Develop an understanding of the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in MIBC, and evaluate available data documenting the benefit of adjuvant anti-PD-1/PD-L1 antibody therapy for patients with positive ctDNA test results after cystectomy.
• Assess the biological rationale for, available research findings with and potential role of promising investigational agents for NMIBC and MIBC.

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 Interview: 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/ASCOGU2026/nmBladder/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:

Matthew D Galsky, MD
Lillian and Howard Stratton Professor of Medicine
Icahn School of Medicine at Mount Sinai
Co-Leader, Bladder Cancer Center of Excellence
Associate Director, Translational Research
The Tisch Cancer Institute
New York, New York

Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, EMD Serono Inc, Gilead Sciences Inc, Janssen Biotech Inc, Merck, Pfizer Inc, Seagen Inc.

Shilpa Gupta, MD
Professor of Medicine
Cleveland Clinic Lerner College of Medicine at Case Western Reserve University
Director, Genitourinary Oncology Program
Taussig Cancer Institute, Cleveland Clinic
Cleveland, Ohio

Advisory Committees: Bristol Myers Squibb, Merck, Novartis, Pfizer Inc, Tyra Biosciences Inc; Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Convergent Therapeutics Inc, Foundation Medicine, Johnson & Johnson, Merck, Pfizer Inc; Contracted Research: Amgen Inc, Bristol Myers Squibb, Convergent Therapeutics Inc, Flare Therapeutics, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc, Tyra Biosciences Inc; Data and Safety Monitoring Boards/Committees: Protara Therapeutics.

Andrea Necchi, MD
Associate Professor
Vita-Salute San Raffaele University
Head of Genitourinary Medical Oncology
IRCCS San Raffaele Hospital
Milan, Italy

Advisory Committees: Bristol Myers Squibb, CatalYm, Daiichi Sankyo Inc, Genenta Science, Johnson & Johnson, Merck; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Johnson & Johnson, Merck, Pfizer Inc, Samsung Bioepis; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Merck.

CONSULTING CLINICAL INVESTIGATORS — Elizabeth R Plimack, MD, MS — Advisory Committees: 23andMe, Adaptimmune, Astellas, Bristol Myers Squibb, Cyana Therapeutics, Daiichi Sankyo Inc, Domain Therapeutics, Eisai Inc, enGene, Flatiron Health, Johnson & Johnson, Merck, Natera Inc, Ottimo Pharma, Pfizer Inc, UroGen Pharma; Contracted Research: Bristol Myers Squibb, Merck. Thomas Powles, MBBS, MRCP, MD — Advisory Committees and Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Eisai Inc, Exelixis Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Johnson & Johnson, Merck Serono, MSD, Novartis, Pfizer Inc, Roche Laboratories inc, Seagen Inc; Nonrelevant Financial Relationships: Mashup Media LLC.

MODERATOR
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.

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 Genentech, a member of the Roche Group, Johnson & Johnson, and Natera Inc.

Release date: March 2026
Expiration date: March 2027

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

Dr Friedlander

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.

Li R et al. Bladder-sparing therapy for bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer: International Bladder Cancer Group recommendations for optimal sequencing and patient selection. Eur Urol 2024;86(6):516-27. Abstract

Powles T et al. Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study. ASCO 2025;Abstract 4517.

Roupret M et al. ALBAN: A phase III, randomized, open-label, international study of intravenous (iv) atezolizumab and intravesical bacillus Calmette-Guérin (BCG) vs BCG alone in BCG-naïve high-risk, non-muscle-invasive bladder cancer (NMIBC). ESMO 2025;Abstract LBA107.

Shore ND et al. Sasanlimab in combination with bacillus Calmette-Guérin improves event-free survival versus bacillus Calmette-Guérin as standard of care in high-risk non-muscle-invasive bladder cancer: Phase 3 CREST study results. J Urol 2025;213(5S2):e1. Abstract

Steinberg GD et al. CREST: Phase III study of sasanlimab and bacillus Calmette-Guérin for patients with bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer. Future Oncol 2024;20(14):891-901. Abstract

Wiesen B et al. Updated review on novel therapies and ongoing clinical trials for high-risk non-muscle invasive bladder cancer. Front Oncol 2025:15:1519428. Abstract

Dr Gupta

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.

Powles TB et al. A randomized 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.

Powles T et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med 2024;390(10):875-88. Abstract

Vulsteke C et al. Perioperative enfortumab vedotin and pembrolizumab in bladder cancer. N Engl J Med 2026;[Online ahead of print]. Abstract

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.

Prof Necchi

Daneshmand S et al. Erdafitinib in patients with high- and intermediate-risk non–muscle-invasive bladder cancer: Final analysis of THOR-2 study. Eur Urol 2026;89(2):165-73. Abstract

Guerrero-Ramos F et al. Association of molecular markers with clinical response to TAR-200 in the phase IIb SunRISe-1 trial in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. ESMO 2025;Abstract 3088P.

Guerrero-Ramos F et al. TAR-200 monotherapy in patients with bacillus Calmette-Guérin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: First results from cohort 4 of SunRISe-1. J Urol 2025;213(5S2):e2. Abstract

Jacob JM et al. TAR-200 monotherapy in patients with bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. 2025;213(5S2):e2. Abstract

Kamat AM et al. Definitions, end points, and clinical trial designs for non-muscle-invasive bladder cancer: Recommendations from the International Bladder Cancer Group. J Clin Oncol 2016;34(16):1935-44. Abstract

Knowles MA, Hurst CD. Molecular biology of bladder cancer: New insights into pathogenesis and clinical diversity. Nat Rev Cancer 2015;15:25-41. Abstract

Necchi A et al. Gemcitabine intravesical system (Gem-iDRS) in combination with cetrelimab (CET) versus chemoradiotherapy (CRT) in muscle-invasive bladder cancer (MIBC): SunRISe-2 final results. Genitourinary Cancers Symposium 2026;Abstract 635.

Necchi A et al. Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in muscle-invasive bladder cancer: SunRISe-4 primary analysis and biomarker results. J Clin Oncol 2026;44(7):586-97. Abstract

Tyson MD et al. Pivotal results from BOND-003: A phase 3, single-arm study of intravesical cretostimogene grenadenorepvec for the treatment of high risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. J Urol 2024;211(5S2):e1. Abstract

Vilaseca A et al. First safety and efficacy results of the TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer with select FGFR alterations. J Urol 2024;211(5S):e987. Abstract

Dr Galsky

Galsky MD et al. Adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. Ann Oncol 2026;37(1):69-78. Abstract

Galsky MD et al. Adjuvant nivolumab in high-risk muscle-invasive urothelial carcinoma: Expanded efficacy from CheckMate 274. J Clin Oncol 2025;43(1):15-21. Abstract

Powles T et al. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. ASCO 2025;Abstract 4503.

Powles T et al. ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer. N Engl J Med 2025;393(24):2395-408. Abstract

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

Powles T et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature 2021;595(7867):432-7. Abstract

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 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:

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 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 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 program is intended for hematologists, medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of follicular lymphoma and diffuse large B-cell lymphoma.

LEARNING OBJECTIVES

• Identify patients with newly diagnosed and relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) for whom CD79b-targeted therapy would be appropriate.
• Develop an understanding of published clinical research findings with CD19-targeted monoclonal antibodies in combination with immunomodulatory agents for DLBCL and follicular lymphoma (FL), and use this information in patient-education discussions.
• Appraise available research findings with and the current clinical role of CD19-targeted antibody-drug conjugates for patients with R/R DLBCL and FL.
• Understand the biological rationale for, available research findings with and current clinical role of CD30-targeted antibody-drug conjugate-based therapy for patients with R/R DLBCL.
• Consider published and emerging research data with and the current clinical role of CD20 x CD3 bispecific antibodies for patients with R/R DLBCL and FL.
• Implement a plan of care to recognize and manage side effects and toxicities associated with novel therapies commonly used in the care of patients with DLBCL and FL.
• Recall new data with agents and strategies currently under investigation for DLBCL and FL, and discuss ongoing trial opportunities with eligible patients.

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 specialties: medical oncology and hematology.

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 CE 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/ASHFLDLBCL25/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:

Nancy L Bartlett, MD
Professor of Medicine
Koman Chair in Medical Oncology
Washington University School of Medicine
St Louis, Missouri

Advisory Committees: AbbVie Inc, Genentech, a member of the Roche Group, Genmab US Inc, Kite, A Gilead Company, Pfizer Inc, Seagen Inc; Contracted Research: AbbVie Inc, ADC Therapeutics, Autolus, Bristol Myers Squibb, Celgene Corporation, Forty Seven Inc, Genentech, a member of the Roche Group, Genmab US Inc, Gilead Sciences Inc, Kite, A Gilead Company, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Seagen Inc, Takeda Pharmaceuticals USA Inc.

John P Leonard, MD
Laura and Isaac Perlmutter Professor of Hematology and Medical Oncology
Director, Division of Hematology and Medical Oncology
Director, Center for Blood Cancers
Senior Advisor to the Dean/CEO and Chief Clinical Officer for Enterprise Cancer Strategy and Operations
Interim Director, Laura and Isaac Perlmutter Cancer Center
NYU Grossman School of Medicine
NYU Langone Health
New York, New York

Consulting Agreements: AstraZeneca Pharmaceuticals LP, BeOne, Caribou Biosciences Inc, Foresight Diagnostics, Genentech, a member of the Roche Group, Ipsen Biopharmaceuticals Inc, Kyowa Kirin Co Ltd, Novartis, Ono Pharmaceutical Co Ltd, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sail Biomedicines, Treeline Biosciences.

Matthew Matasar, MD
Chief, Division of Blood Disorders
Rutgers Cancer Institute
Hematologist/Oncologist
Professor
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey

Advisory Committees: Allogene Therapeutics, Arvinas, Bristol Myers Squibb, Genentech, a member of the Roche Group, Genmab US Inc, Merck; Consulting Agreements: AbbVie Inc, Genentech, a member of the Roche Group, Novartis, Pfizer Inc, Roche Laboratories Inc; Contracted Research: Genentech, a member of the Roche Group, Janssen Biotech Inc, Pfizer Inc, Roche Laboratories Inc; Honoraria and Stipends: ADC Therapeutics, AstraZeneca Pharmaceuticals LP, Ipsen Biopharmaceuticals Inc, Kite, A Gilead Company, Regeneron Pharmaceuticals Inc; Stock Ownership — Public Companies: Merck.

Loretta J Nastoupil, MD
Oncologist
Southwest Oncology
CommonSpirit Mercy Hospital
Durango, Colorado

Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Genmab US Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, Kite, A Gilead Company, Merck, Novartis, Regeneron Pharmaceuticals Inc, Takeda Pharmaceuticals USA Inc; Consulting Agreements: Genentech, a member of the Roche Group; Contracted Research: BeOne, Bristol Myers Squibb, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Janssen Biotech Inc, Kite, A Gilead Company, Merck, Novartis, Takeda Pharmaceuticals USA Inc; Data and Safety Monitoring Boards/Committees: Genentech, a member of the Roche Group.

Professor Pier Luigi Zinzani
Professor of Hematology
Alma Mater Studiorum — University of Bologna
Head, “Seràgnoli” Institute of Hematology
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Department of Medical and Surgical Sciences
Bologna University School of Medicine
Bologna, Italy

Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Gilead Sciences Inc, Incyte Corporation, Janssen Biotech Inc, Kyowa Kirin Co Ltd, Novartis, Recordati, Roche Laboratories Inc, Sobi, Takeda; Speakers Bureaus: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Gilead Sciences Inc, Incyte Corporation, Janssen Biotech Inc, Kyowa Kirin Co Ltd, Merck, Novartis, Recordati, Roche Laboratories Inc, Sobi, Takeda.

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 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 ADC Therapeutics, Genentech, a member of the Roche Group, Incyte Corporation, and Pfizer 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 Matasar

Davies JR et al. Comparison of MHG and DZsig reveals shared biology and a core overlap group with inferior prognosis in DLBCL. Blood Adv 2023;7(20):6156-62. Research Letter

Jerkeman M et al. Initial safety data from the phase 3 POLAR BEAR trial in elderly or frail patients with diffuse large cell lymphoma, comparing R-pola-mini-CHP and R-mini-CHOP. European Hematology Association (EHA) 2023;Abstract S227.

Morschhauser F et al. Deciphering the clinical benefit of Pola-R-CHP versus R-CHOP in different genetic subtypes beyond cell of origin in the POLARIX study. ASH 2023;Abstract 3000.

Palmer AC et al. Cell-of-origin subtypes and therapeutic benefit from polatuzumab vedotin. N Engl J Med 2023;389(8):764-6. Correspondence

Sehn LH et al. Polatuzumab vedotin in relapsed or refractory diffuse large B-cell lymphoma. J Clin Oncol 2020;38(2):155-65. Abstract

Tilly H et al. Polatuzumab vedotin in previously untreated diffuse large B-cell lymphoma. N Engl J Med 2022 ;386(4):351-63. Abstract

Trnĕný M et al. Analysis of peripheral neuropathy in the POLARIX study using clinician- and patient-reported outcomes. Blood Adv 2025;9(13):3263-7. Research Letter

Wright GW et al. A probabilistic classification tool for genetic subtypes of diffuse large B cell lymphoma with therapeutic implications. Cancer Cell 2020;37(4):551-68. Abstract

Dr Leonard

Cheson BD et al. Diffuse large B-cell lymphoma: New targets and novel therapies. Blood Cancer J 2021;11(4):68. Abstract

Duell J et al. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: Final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica 2024;109(2):553-66. Abstract

Meisel A et al. Tafasitamab and lenalidomide as second-line treatment in an elderly patient with a primary refractory double-hit diffuse large B-cell lymphoma. healthbook TIMES Onco Hema 2025;23(1):151-58. Abstract

Nowakowski GS et al. First-Mind: Final analysis from a phase Ib, open-label, randomized study to assess safety of tafasitamab or tafasitamab + lenalidomide in addition to R-CHOP in patients with newly diagnosed diffuse large B-cell lymphoma. ASH 2022;Abstract 1619.

Sehn LH et al. Outcomes from the phase 3 inMIND study of tafasitamab (TAFA) plus lenalidomide (LEN) and rituximab (R) for patients with relapsed/refractory follicular lymphoma (R/R FL). International Conference on Malignant Lymphoma (ICML) 2025;Abstract 28.

Sehn LH et al. Tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: Results from a phase 3 study (inMIND). ASH 2024;Abstract LBA-1.

Vitolo U et al. frontMIND: A phase III, randomized, double-blind study of tafasitamab + lenalidomide + R-CHOP versus R-CHOP alone for newly diagnosed high-intermediate and high-risk diffuse large B-cell lymphoma. ASCO 2022;Abstract TPS7590.

Volgina A et al. CD19 expression persists in diffuse large B-cell lymphoma patient biopsies after treatment with tafasitamab. EHA 2024;Abstract P1234.

Prof Zinzani

Alderuccio JP et al. Initial results from LOTIS-7: A phase 1b study of loncastuximab tesirine plus glofitamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). ICML 2025;Abstract 78.

Alderuccio JP et al. Loncastuximab tesirine with rituximab in patients with relapsed or refractory follicular lymphoma: A single-centre, single-arm, phase 2 trial. Lancet Haematol 2025;12(1):e23-34. Abstract

Bartlett NL et al. Brentuximab vedotin combination for relapsed diffuse large B-cell lymphoma. J Clin Oncol 2025;43(9):1061-72. Abstract

Hamadani M et al. Clinical outcomes of older and younger patients treated with loncastuximab tesirine in the LOTIS-2 clinical trial. Blood Adv 2024;8(1):93-8. Research Letter

Kim JA et al. Brentuximab vedotin in combination with lenalidomide and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma: Results from the phase 3 ECHELON-3 study. ASCO 2024;Abstract LBA7005.

Matasar M et al. Polatuzumab vedotin, rituximab, gemcitabine and oxaliplatin (POLA-R-GEMOX) for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Results from the randomized phase III POLARGO trial. EHA 2025;Abstract S101.

Dr Bartlett

Abramson JS et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): A global phase 3, randomised, open-label trial. Lancet 2024;404(10466):1940-54. Abstract

Bartlett NL et al. Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory diffuse large B-cell lymphoma. Blood Adv 2023;7(17):4926-35. Abstract

Brody JD et al. Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: Results from the EPCORE NHL-2 trial. Blood 2025;145(15):1621-31. Abstract

Budde LE et al. Mosunetuzumab plus polatuzumab vedotin in transplant-ineligible refractory/relapsed large B-cell lymphoma: Primary results of the phase III SUNMO trial. J Clin Oncol 2025;43(36):3799-811. Abstract

Dickinson MJ et al. Fixed-duration glofitamab monotherapy continues to demonstrate durable responses in patients with relapsed or refractory large B-cell lymphoma: 3-year follow-up from a pivotal phase II study. ASH 2024;Abstract 865.

Dickinson MJ et al. Glofitamab for relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med 2022;387(24):2220-31. Abstract

Falchi L et al. Fixed-duration epcoritamab + R-CHOP in patients with newly diagnosed DLBCL and high IPI scores (3–5) led to sustained remissions and disease-free survival beyond 3 years: Results from the EPCORE NHL-2 trial. ASH 2025;Abstract 1955.

Falchi L et al. Bispecific antibodies for the treatment of B-cell lymphoma: Promises, unknowns, and opportunities. Blood 2023;141(5):467-80. Abstract

Hutchings M et al. Efficacy and safety of glofitamab plus polatuzumab vedotin in relapsed/refractory large B-cell lymphoma including high-grade B-cell lymphoma: Results from a phase Ib/II trial. J Clin Oncol 2025;43(36):3788-98. Abstract

Kim WS et al. Odronextamab monotherapy in patients with relapsed/refractory diffuse large B cell lymphoma: Primary efficacy and safety analysis in phase 2 ELM-2 trial. Nat Cancer 2025;6(3):528-39. Abstract

Lavie D et al. Durable efficacy with fixed-duration epcoritamab + polatuzumab, vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (POLA-R-CHP) for 1L DLBCL (EPCORE NHL-5). ICML 2025;Abstract 282.

Li T et al. Optimal dosing regimen for epcoritamab, a subcutaneous bispecific antibody, in relapsed or refractory large B-cell lymphoma. Clin Pharmacol Ther 2025;117(5):1437-50. Abstract

Minson A et al. Glofitamab combined with Pola-R-CHP or R-CHOP as first therapy in younger patients with high-risk large B-cell lymphoma: Results from the COALITION study. J Clin Oncol 2025;43(23):2595-605. Abstract

Minson AG, Dickinson MJ. New bispecific antibodies in diffuse large B-cell lymphoma. Haematologica 2025 ;110(7):1483-99. Abstract

Thieblemont C et al. Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial. Leukemia 2024;38(12):2653-62. Abstract

Westin J et al. Mosunetuzumab plus Pola-CHP compared with Pola-R-CHP in previously untreated DLBCL: Final results from a phase 2 study. Blood Adv 2025;9(10):2461-72. Abstract

Dr Nastoupil

Blair HA. Odronextamab: First approval. Drugs 2024;84(12):1651-8. Abstract

Budde LE et al. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: A single-arm, multicentre, phase 2 study. Lancet Oncol 2022;23(8):1055-65. Abstract

Devata S et al. AZD0486, a novel CD19XCD3 T-cell engager, shows durable responses in patients with relapsed/refractory follicular lymphoma: Update on efficacy and safety. EHA 2024;Abstract P1131.

Flinn IW et al. Fixed duration subcutaneous (SC) mosunetuzumab (Mosun) in patients with previously untreated high-tumor burden follicular lymphoma (FL): Interim results from the phase II MorningSun study. ASCO 2025;Abstract 7014.

Karimi Y et al. Effect of follow-up time on the ability of subcutaneous epcoritamab to induce deep and durable complete remissions in patients with relapsed/refractory large B-cell lymphoma: Updated results from the pivotal EPCORE NHL-1 trial. ASCO 2023;Abstract 7525.

Kim TM et al. Efficacy and safety of odronextamab in relapsed/refractory marginal zone lymphoma (R/R MZL): Data from the R/R MZL cohort in the ELM-2 study. ASH 2024;Abstract 862.

Linton KM et al. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): A phase 2 cohort of a single-arm, multicentre study. Lancet Haematol 2024;11(8):e593-605. Abstract

Luminari S et al. Long-term efficacy and survival outcomes with odronextamab for patients (pts) with relapsed/refractory follicular lymphoma (R/R FL): 2-year follow-up from the phase 2 ELM-2 study. EHA 2025;Abstract S235.

Nastoupil LJ et al. CELESTIMO: A phase III trial evaluating the efficacy and safety of mosunetuzumab plus lenalidomide versus rituximab plus lenalidomide in patients with relapsed or refractory follicular lymphoma who have received ≥ 1 line of systemic therapy. ASCO 2022;Abstract TPS7588.

Phillips T et al. Glofitamab monotherapy in patients with heavily pretreated relapsed or refractory mantle cell lymphoma: Updated analysis from a phase I/II study. EHA 2024;Abstract S231.

Phillips TJ et al. GLOBRYTE: A phase III, open-label, multicenter, randomized trial evaluating glofitamab monotherapy in patients with relapsed or refractory mantle cell lymphoma. ASH 2023;Abstract 3052.

Sehn LH et al. Long-term 3-year follow-up of mosunetuzumab in relapsed or refractory follicular lymphoma after ≥2 prior therapies. Blood 2025;145(7):708-19. Abstract

Thieblemont C et al. Epcoritamab, a novel, subcutaneous CD3xCD20 bispecific T-cell-engaging antibody, in relapsed or refractory large B-cell lymphoma: Dose expansion in a phase I/II trial. J Clin Oncol 2023;41(12):2238-47. Abstract

Thiruvengadam S et al. Phase II investigator-initiated trial of epcoritamab-lenalidomide in treatment naïve follicular lymphoma. EHA 2025;Abstract PS1892.

Wang ML et al. Fixed duration mosunetuzumab plus polatuzumab vedotin has promising efficacy and a manageable safety profile in patients with BTKi relapsed/refractory mantle cell lymphoma: Initial results from a phase Ib/II study. ASH 2023;Abstract 734.