Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows and other healthcare providers involved in the treatment of chronic lymphocytic leukemia.

LEARNING OBJECTIVES

• Individualize the selection of systemic therapy for newly diagnosed chronic lymphocytic leukemia (CLL), considering new research findings, clinical presentation, biomarker profile, coexisting medical conditions and patient preferences for time-limited or continuous treatment.
• Appreciate the scientific rationale for the investigation of combined Bruton tyrosine kinase (BTK) and Bcl-2 inhibition, and review recently presented data documenting the safety and efficacy of this strategy for patients with CLL.
• Analyze how age, performance status, prior therapeutic exposure and other biological and disease-related factors affect the selection and sequencing of therapy for patients with relapsed/refractory (R/R) CLL.
• Discuss available clinical research findings demonstrating the efficacy and safety of noncovalent BTK inhibitors in CLL, and use this information to effectively incorporate these agents into the care of patients with R/R disease.
• Evaluate the biological rationale for the investigation of CD19-directed chimeric antigen receptor T-cell therapy for CLL, and identify patients for whom this novel therapeutic strategy would be appropriate.
• Implement a plan of care to recognize and manage side effects and toxicities associated with available systemic therapies commonly employed in the treatment of CLL.
• Recall available and emerging data with novel agents and combination strategies currently under investigation for CLL, and as applicable, refer eligible patients for clinical 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
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology 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 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/ASCO2025/CLL/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:

Catherine C Coombs, MD
Associate Clinical Professor
Division of Hematology/Oncology
Department of Medicine
UCI Health
Orange County, California

Advisory Committees: AbbVie Inc, Allogene Therapeutics, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, Genentech, a member of the Roche Group, Janssen Biotech Inc, Lilly, MingSight Pharmaceuticals, Pharmacyclics LLC, an AbbVie Company; Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Lilly, Octapharma; Contracted Research: AbbVie Inc, BeiGene Ltd, Carna Biosciences, Lilly; Speakers Bureaus: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Genentech, a member of the Roche Group, Lilly; Stock Options/Stock — Public Companies: Geron Corporation, Pfizer Inc.

William G Wierda, MD, PhD
Jane and John Justin Distinguished Chair in Leukemia Research in Honor of Dr Elihu Estey
Section Chief, Chronic Lymphocytic Leukemia
Center Medical Director
Department of Leukemia, Division of Cancer Medicine
Executive Medical Director, Inpatient Medical Services
The University of Texas MD Anderson Cancer Center
Houston, Texas

Consulting Agreements: BeiGene Ltd, Numab Therapeutics AG; Contracted Research: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Bristol Myers Squibb, Cyclacel Pharmaceuticals Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, GSK, Janssen Biotech Inc, Juno Therapeutics, a Celgene Company, Kite, A Gilead Company, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Novartis, Nurix Therapeutics Inc, Oncternal Therapeutics, Pharmacyclics LLC, an AbbVie Company; Nonrelevant Financial Relationships: National Comprehensive Cancer Network (Chair, CLL), Support by the NIH/NCI under award number P30 CA016672 and use of MD Anderson Cancer Center Support Grant (CCSG) shared resources.

SURVEY PARTICIPANTS
John N Allan, MD — Advisory Committees: NeoGenomics; Consulting Agreements: AbbVie Inc, Adaptive Biotechnologies Corporation, ADC Therapeutics, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Genentech, a member of the Roche Group, Janssen Biotech Inc, Lilly, Pharmacyclics LLC, an AbbVie Company; Contracted Research: BeiGene Ltd, Bristol Myers Squibb, Genentech, a member of the Roche Group; Data and Safety Monitoring Boards/Committees: Merck; Speakers Bureaus: AbbVie Inc, BeiGene Ltd. Matthew S Davids, MD, MMSc — Consulting Agreements: AbbVie Inc, Adaptive Biotechnologies Corporation, Ascentage Pharma, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, Galapagos NV, Genentech, a member of the Roche Group, Genmab US Inc, Janssen Biotech Inc, Lilly, MEI Pharma Inc, Merck, Nuvalent, Schrödinger, Secura Bio, Takeda Pharmaceuticals USA Inc, TG Therapeutics Inc; Contracted Research: Ascentage Pharma, MEI Pharma Inc, Novartis; Nonrelevant Financial Relationships: UpToDate. Jeff Sharman, MD — Consulting Agreements and Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, Genentech, a member of the Roche Group, Lilly, Merck. Tanya Siddiqi, MD — Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, Celgene Corporation, Gilead Sciences Inc; Contracted Research: Bristol Myers Squibb; Data and Safety Monitoring Boards/Committees: BeiGene Ltd; Speakers Bureaus: AstraZeneca Pharmaceuticals LP.

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, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic 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, 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, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

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

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

These activities are supported by an educational grant from Lilly.

Release date: July 2025
Expiration date: July 2026

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

Dr Wierda

Module 1: Selection and Sequencing of Therapy for Relapsed/Refractory (RR) Chronic Lymphocytic Leukemia (CLL)

Escalón MP et al. BRUIN CLL-314: A phase 3, open-label, randomized study of pirtobrutinib versus ibrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (trial in progress). iwCLL 2023;Abstract 1548596.

Eyre TA et al. BRUIN CLL-322: A phase 3 open-label, randomized study of fixed duration pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma. ASCO 2023;Abstract TPS7583.

Jurczak W et al. BRUIN CLL-313: A phase 3 open-label, randomized study of pirtobrutinib versus bendamustine plus rituximab in untreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (trial in progress). ASH 2021;Abstract 3732.

Mato AR et al. Efficacy of pirtobrutinib in covalent BTK-inhibitor pre-treated relapsed / refractory CLL/SLL: Additional patients and extended follow-up from the phase 1/2 BRUIN study. ASH 2022;Abstract 961.

Ng J et al. Cardiovascular adverse effects of novel Bruton tyrosine kinase inhibitors: What all cardiologists should know. American College of Cardiology, August 16, 2023. https://www.acc.org/Latest-in-Cardiology/Articles/2023/08/15/16/45/CV-Adverse-Effects-of-Novel-Bruton-Tyrosine-Kinase-Inhibitors

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

Wierda WG et al. Lisocabtagene maraleucel (liso-cel) combined with ibrutinib (ibr) for patients (pts) with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary results from the open-label, phase 1/2 Transcend CLL 004 study. ASH 2024;Abstract 887.

Module 3: Novel Agents and Strategies for RR CLL

Danilov A et al. Epcoritamab monotherapy in patients (Pts) with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL): Results from CLL expansion and optimization cohorts of Epcore CLL-1. ASH 2024;Abstract 883.

Shah NN et al. Efficacy and safety of the Bruton’s tyrosine kinase (BTK) degrader NX-5948 in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): Updated results from an ongoing phase 1a/b study. ASH 2024;Abstract 884.

Thompson MC et al. Preliminary efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: Results from the phase 1 cadance-101 study. ASH 2024​;Abstract 885.

 

Dr Coombs

Module 2: First-Line Therapy for CLL

Al-Sawaf O et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized CLL14 study. EHA 2023;Abstract S145.

Barr PM et al. Up to 8-year follow-up from RESONATE-2: First-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Blood Adv 2022;6(11):3440-50. Abstract

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

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

Brown JR et al. Extended follow-up of ALPINE randomized phase 3 study confirms sustained superior progression-free survival of zanubrutinib versus ibrutinib for treatment of relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma (R/R CLL/SLL). ASH 2023;Abstract 202.

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

Byrd JC et al. Acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia: Results of the first randomized phase III trial. J Clin Oncol 2021;39(31):3441-52. Abstract

Davids MS et al. Phase II study of acalabrutinib, venetoclax, and obinutuzumab in a treatment-naïve chronic lymphocytic leukemia population enriched for high-risk disease. J Clin Oncol 2025;43(7):788-99. Abstract

Eichhorst B et al. Time-limited venetoclax-obinutuzumab +/- ibrutinib is superior to chemoimmunotherapy in frontline chronic lymphocytic leukemia (CLL): PFS co-primary endpoint of the randomized phase 3 GAIA/CLL13 trial. EHA 2022;Abstract LB2365.

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

O’Brien SM et al. Monitoring and managing BTK inhibitor treatment-related adverse events in clinical practice. Front Oncol 2021;11. Abstract

Ryan CE et al. MAJIC: A phase III trial of acalabrutinib + venetoclax versus venetoclax + obinutuzumab in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Future Oncol 2022;18(33):3689-99. Abstract

Shadman M et al. Zanubrutinib versus bendamustine and rituximab in patients with treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma: Median 5-year follow-up of SEQUOIA. J Clin Oncol 2025;43(7):780-7. Abstract

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

Sharman JP et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): A randomised, controlled, phase 3 trial. Lancet 2020;395(10232):1278-91. Abstract

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

Faculty

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

LEARNING OBJECTIVES

• Appreciate the incidence of KMT2A translocations or NPM1 mutations in patients with acute leukemias, and understand the significance of these abnormalities for prognosis, biomarker assessment and current management.
• Describe the mechanism of action of menin inhibitors and review the rationale for their activity in patients with KMT2A-rearranged and NPM1-mutant acute leukemias.
• Evaluate available efficacy and safety data with the use of menin inhibitors in patients with previously treated KMT2A-rearranged acute leukemias, and optimally integrate the single FDA-approved agent into current management algorithms.
• Assess published and emerging clinical trial findings with available and investigational menin inhibitors for the treatment of NPM1-mutant acute myeloid leukemia (AML), and consider the implications for current and future management.
• Understand the spectrum, incidence and severity of side effects, including differentiation syndrome and cardiac toxicity, associated with menin inhibitors, and develop appropriate monitoring and management protocols.
• Appreciate the rationale for combining menin inhibitors with other standard regimens in AML and recall ongoing trials evaluating these novel strategies.

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 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1.25 (video) and 0.75 (lecture) 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 CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/OncologyTodayMeninAML24/Video and evaluation ResearchToPractice.com/OncologyTodayMeninAML24/Video/CME.

Video Lecture: ResearchToPractice.com/OncologyTodayMeninAML24/Presentation and evaluation ResearchToPractice.com/OncologyTodayMeninAML24/Presentation/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:

Ghayas Issa, MD
Associate Professor
Department of Leukemia
The University of Texas MD Anderson Cancer Center
Houston, Texas

Consultancy or Advisory Boards: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Biostate, Crossbow Therapeutics, Kura Oncology, Novartis, Sanofi, Syndax Pharmaceuticals; Research Funding: Astex Pharmaceuticals, Celgene Corporation, Crossbow Therapeutics, Cullinan Therapeutics, Daiichi Sankyo Inc, Kura Oncology, Merck, Novartis, Pupil Bio, Sumitomo Dainippon Pharma Oncology Inc, Syndax Pharmaceuticals; Scientific Advisory Boards: Biostate, Pupil Bio.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic 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, 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, 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 Johnson & Johnson, Kura Oncology, and Syndax Pharmaceuticals.

Release date: July 2025
Expiration date: July 2026

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

Arellano ML et al. Menin inhibition with revumenib for NPM1-mutated relapsed or refractory acute myeloid leukemia: The AUGMENT-101 study. Blood 2025;[Online ahead of print]. Abstract

Issa GC et al. Menin inhibition with revumenib for KMT2A-rearranged relapsed or refractory acute leukemia (AUGMENT-101). J Clin Oncol 2025;43(1):75-84. Abstract

Issa GC et al. Clinical outcomes associated with NPM1 mutations in patients with relapsed or refractory AML. Blood Adv 2023;7(6):933-42. Abstract

Issa GC et al. The menin inhibitor revumenib in KMT2A-rearranged or NPM1-mutant leukaemia. Nature 2023;615(7954):920-4. Abstract

Mahdavi L et al. Clonal evolution mediates menin-inhibitor resistance in KMT2A-rearranged leukemias. bioRxiv 2023. Abstract

Perner F et al. MEN1 mutations mediate clinical resistance to menin inhibition. Nature 2023;615:913-9. Abstract

Soto-Feliciano YM et al. A molecular switch between mammalian MLL complexes dictates response to menin-MLL inhibition. Cancer Discov 2023;13(1):146-69. Abstract

Wang ES et al. Ziftomenib in relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML): Phase 1b/2 clinical activity and safety results from the pivotal KOMET-001 study. ASCO 2025;Abstract 6506

Wang ES et al. Ziftomenib in relapsed or refractory acute myeloid leukaemia (KOMET-001): A multicentre, open-label, multi-cohort, phase 1 trial. Lancet Oncol 2024;25:1310-24. Abstract

Faculty

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

LEARNING OBJECTIVES

• Consider emerging research information and available guideline recommendations to individualize first- and later-line therapy for patients with non-small cell lung cancer (NSCLC) harboring various targetable genomic abnormalities beyond EGFR.
• Communicate the efficacy and safety of approved and investigational ALK inhibitors to patients with localized and metastatic NSCLC for whom treatment with these agents would be appropriate.
• Convey the clinical relevance of a positive ROS1 mutation testing result to applicable patients with NSCLC, and appreciate available research findings with approved and investigational agents demonstrating efficacy in this disease subtype.
• Assess available research evidence with approved RET inhibitors, and use this information to guide clinical care for patients with newly diagnosed or progressive NSCLC.
• Consider available research information and guideline recommendations to individualize first- and later-line therapy for patients with HER2-mutant or overexpressing NSCLC.
• Understand the biology of KRAS G12C mutations, and evaluate available research findings to optimally incorporate available agents into the care of patients with these abnormalities.
• Reflect on investigational agents and strategies currently in testing for NSCLC with targetable genomic abnormalities beyond EGFR, and refer eligible patients for clinical trial participation.

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

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

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

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

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation 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/YiR2024/TargetedLung/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:

Jessica J Lin, MD
Attending Physician
Massachusetts General Hospital
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Advisory Committees: Bristol Myers Squibb, Genentech, a member of the Roche Group, Nuvalent; Consulting Agreements: AnHeart Therapeutics, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Blueprint Medicines, Bristol Myers Squibb, C4 Therapeutics, CLaiM Therapeutics, Daiichi Sankyo Inc, Elevation Oncology, Ellipses Pharma, Genentech, a member of the Roche Group, Gilead Sciences Inc, Janssen Biotech Inc, Lilly, Merus, Mirati Therapeutics Inc, Novartis, Nuvalent, Nuvation Bio, Pfizer Inc, Regeneron Pharmaceuticals Inc, Roche Laboratories Inc, Takeda Pharmaceuticals USA Inc, Turning Point Therapeutics Inc, Yuhan USA; Contracted Research (Received Institutional Research Funds): Bayer HealthCare Pharmaceuticals, BioNTech SE, Elevation Oncology, Hengrui Therapeutics Inc, Linnaeus Therapeutics, Novartis, Nuvalent, Relay Therapeutics, Roche Laboratories Inc, Turning Point Therapeutics Inc; Travel Support: Bristol Myers Squibb, Merus, Pfizer Inc, Takeda Pharmaceuticals USA Inc.

Joel W Neal, MD, PhD
Professor of Medicine, Division of Oncology
Stanford University School of Medicine
Medical Director, Cancer Clinical Trials Office
Stanford Cancer Institute
Medical Director, Informatics Technology
Stanford Medicine Cancer Center
Stanford, California

Advisory Committees (Consulting or Advisory Roles): AbbVie Inc, Amgen Inc, AnHeart Therapeutics, AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Bristol Myers Squibb, D2G Oncology Inc, Daiichi Sankyo Inc, Exelixis Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Iovance Biotherapeutics, Janssen Biotech Inc, Lilly, Mirati Therapeutics Inc, Natera Inc, Novartis, Novocure Inc, Nuvation Bio, Regeneron Pharmaceuticals Inc, Sanofi, Summit Therapeutics, Surface Oncology, Takeda Pharmaceuticals USA Inc, Turning Point Therapeutics Inc; Contracted Research: Adaptimmune, Boehringer Ingelheim Pharmaceuticals Inc, Exelixis Inc, Genentech, a member of the Roche Group, GSK, Janssen Biotech Inc, Merck, Nektar Therapeutics, Novartis, Nuvalent, Revolution Medicines, Takeda Pharmaceuticals USA 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, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic 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, 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, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

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

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

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

Release date: June 2025
Expiration date: June 2026

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

Bauer T et al. Kinetics and management of adverse events associated with lorlatinib after 5 years of follow-up in the CROWN study. WCLC 2024;Abstract MA06.08.

Besse B et al. Phase I/II ARROS-1 study of zidesamtinib (NVL-520) in ROS1 fusion-positive solid tumours. ESMO 2024;Abstract 1256MO.

Camidge DR et al. Telisotuzumab vedotin monotherapy in patients with previously treated c-Met protein-overexpressing advanced nonsquamous EGFR-wildtype non-small cell lung cancer in the phase II LUMINOSITY trial. J Clin Oncol 2024;42(25):3000-11. Abstract

Cho BC et al. Updated efficacy and safety of entrectinib in NTRK fusion-positive non-small cell lung cancer. Lung Cancer 2024;188:107442. Abstract

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

Drilon AE et al. Repotrectinib in tyrosine kinase inhibitor (TKI)-naïve patients (pts) with advanced ROS1 fusion-positive (ROS1+) NSCLC in the phase 1/2 TRIDENT-1 trial: Clinical update, treatment beyond progression and subsequent therapies. ASCO 2024;Abstract 8522.

Fujiwara Y et al. Efficacy and safety of olomorasib with pembrolizumab + chemotherapy as first-line treatment in patients with KRAS G12C-mutant advanced NSCLC. WCLC 2024;Abstract OA14.04.

Heymach JV et al. Zongertinib in previously treated HER2-mutant non–small-cell lung cancer. N Engl J Med 2025;[Online ahead of print]. Abstract

Hill L et al. Predictors of long-term ensartinib response from the eXalt3 trial. WCLC 2024;Abstract MA06.09.

Horinouchi H et al. ALINA safety results; adjuvant alectinib vs chemotherapy in patients with resected ALK+ non-small cell lung cancer (NSCLC). WCLC 2024;Abstract OA13.04.

Janne PA et al. Trastuzumab deruxtecan (T-DXd) in patients with HER2-mutant metastatic non-small cell lung cancer (mNSCLC): Final analysis results of DESTINY-Lung02. ASCO 2024;Abstract 8543.

Le X et al. Safety and efficacy of BAY 2927088 in patients with HER2-mutant NSCLC: Expansion cohort from the phase I/II SOHO-01 study. WCLC 2024;Abstract PL04.03.

Lin JJ et al. Updated efficacy, safety, and biomarker analysis in patients with TRK fusion lung cancer treated with larotrectinib. WCLC 2024;Abstract MA06.12.

Liu G et al. Efficacy and safety of taletrectinib in patients with ROS1+ non-small cell lung cancer: The global TRUST-II study. WCLC 2024;Abstract MA06.03.

Mok TSK et al. KRYSTAL-12: Phase 3 study of adagrasib versus docetaxel in patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. ASCO 2024;Abstract LBA8509.

Nützinger J et al. Management of HER2 alterations in non-small cell lung cancer – The past, present, and future. Lung Cancer 2023;186:107385. Abstract

Pérol M et al. CNS protective effect of selpercatinib in first-line RET fusion-positive advanced non-small cell lung cancer. J Clin Oncol 2024;42(21):2500-5. Abstract

Planchard D et al. Trastuzumab deruxtecan monotherapy in pretreated HER2-overexpressing nonsquamous non-small cell lung cancer: DESTINY-Lung03 part 1. WCLC 2024;Abstract OA16.05.

Riely GJ et al. Updated efficacy and safety from the phase II PHAROS study of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic NSCLC (mNSCLC). ESMO 2024;Abstract LBA56.

Ruiter G et al. Primary phase Ib analysis of Beamion LUNG-1: Zongertinib (BI 1810631) in patients with HER2 mutation-positive NSCLC. WCLC 2024;Abstract PL04.04.

Sacher A et al. Divarasib single-agent long-term follow-up and atezolizumab combination treatment in patients with KRAS G12C-positive NSCLC. WCLC 2024;Abstract OA14.06.

Sands J et al. Datopotamab deruxtecan in advanced or metastatic non-small cell lung cancer with actionable genomic alterations: Results from the phase II TROPION-Lung05 study. J Clin Oncol 2025;43(10):1254-65. Abstract

Schram AM et al. Efficacy of zenocutuzumab in NRG1 fusion-positive cancer. N Engl J Med 2025;392(6):566-76. Abstract

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

Solomon BJ et al. Lorlatinib versus crizotinib in patients with advanced ALK-positive non-small cell lung cancer: 5-year outcomes from the phase III CROWN study. J Clin Oncol 2024;42(29):3400-9. Abstract

Waterhouse DM et al. Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation. Lung Cancer 2024;196:107921. Abstract

Wolf J et al. Capmatinib in MET exon 14-Mutated non-small-cell lung cancer: Final results from the open-label, phase 2 GEOMETRY mono-1 trial. Lancet Oncol 2024;25(10):1357-70. Abstract

Wu Y-L et al. Alectinib in resected ALK-positive non-small-cell lung cancer. N Engl J Med 2024;390(14):1265-76. Abstract

Faculty

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

LEARNING OBJECTIVES

• Consider emerging research information and available guideline recommendations to individualize first- and later-line therapy for patients with non-small cell lung cancer (NSCLC) harboring various targetable genomic abnormalities beyond EGFR.
• Communicate the efficacy and safety of approved and investigational ALK inhibitors to patients with localized and metastatic NSCLC for whom treatment with these agents would be appropriate.
• Convey the clinical relevance of a positive ROS1 mutation testing result to applicable patients with NSCLC, and appreciate available research findings with approved and investigational agents demonstrating efficacy in this disease subtype.
• Assess available research evidence with approved RET inhibitors, and use this information to guide clinical care for patients with newly diagnosed or progressive NSCLC.
• Consider available research information and guideline recommendations to individualize first- and later-line therapy for patients with HER2-mutant or overexpressing NSCLC.
• Understand the biology of KRAS G12C mutations, and evaluate available research findings to optimally incorporate available agents into the care of patients with these abnormalities.
• Reflect on investigational agents and strategies currently in testing for NSCLC with targetable genomic abnormalities beyond EGFR, and refer eligible patients for clinical 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
Research To Practice designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.5 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 the 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 this CME activity, 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
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/YiR2024/TargetedLung/Presentations/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:

Jessica J Lin, MD
Attending Physician
Massachusetts General Hospital
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Advisory Committees: Bristol Myers Squibb, Genentech, a member of the Roche Group, Nuvalent; Consulting Agreements: AnHeart Therapeutics, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Blueprint Medicines, Bristol Myers Squibb, C4 Therapeutics, CLaiM Therapeutics, Daiichi Sankyo Inc, Elevation Oncology, Ellipses Pharma, Genentech, a member of the Roche Group, Gilead Sciences Inc, Janssen Biotech Inc, Lilly, Merus, Mirati Therapeutics Inc, Novartis, Nuvalent, Nuvation Bio, Pfizer Inc, Regeneron Pharmaceuticals Inc, Roche Laboratories Inc, Takeda Pharmaceuticals USA Inc, Turning Point Therapeutics Inc, Yuhan USA; Contracted Research (Received Institutional Research Funds): Bayer HealthCare Pharmaceuticals, BioNTech SE, Elevation Oncology, Hengrui Therapeutics Inc, Linnaeus Therapeutics, Novartis, Nuvalent, Relay Therapeutics, Roche Laboratories Inc, Turning Point Therapeutics Inc; Travel Support: Bristol Myers Squibb, Merus, Pfizer Inc, Takeda Pharmaceuticals USA Inc.

Joel W Neal, MD, PhD
Professor of Medicine, Division of Oncology
Stanford University School of Medicine
Medical Director, Cancer Clinical Trials Office
Stanford Cancer Institute
Medical Director, Informatics Technology
Stanford Medicine Cancer Center
Stanford, California

Advisory Committees (Consulting or Advisory Roles): AbbVie Inc, Amgen Inc, AnHeart Therapeutics, AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Bristol Myers Squibb, D2G Oncology Inc, Daiichi Sankyo Inc, Exelixis Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Iovance Biotherapeutics, Janssen Biotech Inc, Lilly, Mirati Therapeutics Inc, Natera Inc, Novartis, Novocure Inc, Nuvation Bio, Regeneron Pharmaceuticals Inc, Sanofi, Summit Therapeutics, Surface Oncology, Takeda Pharmaceuticals USA Inc, Turning Point Therapeutics Inc; Contracted Research: Adaptimmune, Boehringer Ingelheim Pharmaceuticals Inc, Exelixis Inc, Genentech, a member of the Roche Group, GSK, Janssen Biotech Inc, Merck, Nektar Therapeutics, Novartis, Nuvalent, Revolution Medicines, Takeda Pharmaceuticals USA 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, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic 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, 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, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

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

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

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

Release date: June 2025
Expiration date: June 2026

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

Bauer T et al. Kinetics and management of adverse events associated with lorlatinib after 5 years of follow-up in the CROWN study. WCLC 2024;Abstract MA06.08.

Besse B et al. Phase I/II ARROS-1 study of zidesamtinib (NVL-520) in ROS1 fusion-positive solid tumours. ESMO 2024;Abstract 1256MO.

Camidge DR et al. Telisotuzumab vedotin monotherapy in patients with previously treated c-Met protein-overexpressing advanced nonsquamous EGFR-wildtype non-small cell lung cancer in the phase II LUMINOSITY trial. J Clin Oncol 2024;42(25):3000-11. Abstract

Cho BC et al. Updated efficacy and safety of entrectinib in NTRK fusion-positive non-small cell lung cancer. Lung Cancer 2024;188:107442. Abstract

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

Drilon AE et al. Repotrectinib in tyrosine kinase inhibitor (TKI)-naïve patients (pts) with advanced ROS1 fusion-positive (ROS1+) NSCLC in the phase 1/2 TRIDENT-1 trial: Clinical update, treatment beyond progression and subsequent therapies. ASCO 2024;Abstract 8522.

Fujiwara Y et al. Efficacy and safety of olomorasib with pembrolizumab + chemotherapy as first-line treatment in patients with KRAS G12C-mutant advanced NSCLC. WCLC 2024;Abstract OA14.04.

Heymach JV et al. Zongertinib in previously treated HER2-mutant non–small-cell lung cancer. N Engl J Med 2025;[Online ahead of print]. Abstract

Hill L et al. Predictors of long-term ensartinib response from the eXalt3 trial. WCLC 2024;Abstract MA06.09.

Horinouchi H et al. ALINA safety results; adjuvant alectinib vs chemotherapy in patients with resected ALK+ non-small cell lung cancer (NSCLC). WCLC 2024;Abstract OA13.04.

Janne PA et al. Trastuzumab deruxtecan (T-DXd) in patients with HER2-mutant metastatic non-small cell lung cancer (mNSCLC): Final analysis results of DESTINY-Lung02. ASCO 2024;Abstract 8543.

Le X et al. Safety and efficacy of BAY 2927088 in patients with HER2-mutant NSCLC: Expansion cohort from the phase I/II SOHO-01 study. WCLC 2024;Abstract PL04.03.

Lin JJ et al. Updated efficacy, safety, and biomarker analysis in patients with TRK fusion lung cancer treated with larotrectinib. WCLC 2024;Abstract MA06.12.

Liu G et al. Efficacy and safety of taletrectinib in patients with ROS1+ non-small cell lung cancer: The global TRUST-II study. WCLC 2024;Abstract MA06.03.

Mok TSK et al. KRYSTAL-12: Phase 3 study of adagrasib versus docetaxel in patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. ASCO 2024;Abstract LBA8509.

Nützinger J et al. Management of HER2 alterations in non-small cell lung cancer – The past, present, and future. Lung Cancer 2023;186:107385. Abstract

Pérol M et al. CNS protective effect of selpercatinib in first-line RET fusion-positive advanced non-small cell lung cancer. J Clin Oncol 2024;42(21):2500-5. Abstract

Planchard D et al. Trastuzumab deruxtecan monotherapy in pretreated HER2-overexpressing nonsquamous non-small cell lung cancer: DESTINY-Lung03 part 1. WCLC 2024;Abstract OA16.05.

Riely GJ et al. Updated efficacy and safety from the phase II PHAROS study of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic NSCLC (mNSCLC). ESMO 2024;Abstract LBA56.

Ruiter G et al. Primary phase Ib analysis of Beamion LUNG-1: Zongertinib (BI 1810631) in patients with HER2 mutation-positive NSCLC. WCLC 2024;Abstract PL04.04.

Sacher A et al. Divarasib single-agent long-term follow-up and atezolizumab combination treatment in patients with KRAS G12C-positive NSCLC. WCLC 2024;Abstract OA14.06.

Sands J et al. Datopotamab deruxtecan in advanced or metastatic non-small cell lung cancer with actionable genomic alterations: Results from the phase II TROPION-Lung05 study. J Clin Oncol 2025;43(10):1254-65. Abstract

Schram AM et al. Efficacy of zenocutuzumab in NRG1 fusion-positive cancer. N Engl J Med 2025;392(6):566-76. Abstract

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

Solomon BJ et al. Lorlatinib versus crizotinib in patients with advanced ALK-positive non-small cell lung cancer: 5-year outcomes from the phase III CROWN study. J Clin Oncol 2024;42(29):3400-9. Abstract

Waterhouse DM et al. Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation. Lung Cancer 2024;196:107921. Abstract

Wolf J et al. Capmatinib in MET exon 14-Mutated non-small-cell lung cancer: Final results from the open-label, phase 2 GEOMETRY mono-1 trial. Lancet Oncol 2024;25(10):1357-70. Abstract

Wu Y-L et al. Alectinib in resected ALK-positive non-small-cell lung cancer. N Engl J Med 2024;390(14):1265-76. Abstract

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of IDH-mutant low-grade glioma.

LEARNING OBJECTIVES

• Appreciate the incidence of IDH1/2 mutations in patients with low-grade glioma, and understand the biological rationale for the development of therapies designed to target these abnormalities in individuals with the disease.
• Recognize available efficacy and safety findings with the use of novel IDH inhibitors for low-grade glioma and assess the potential role these agents may play in the treatment of the disease.
• Understand the toxicities associated with novel IDH inhibitors under development for low-grade glioma in order to prepare for the potential clinical availability of these agents.
• Recall the design of ongoing clinical trials evaluating novel IDH inhibitors for glioma, and counsel appropriate 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
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1.25 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
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/OncologyTodayIDHMutantGlioma24/Video and evaluation ResearchToPractice.com/OncologyTodayIDHMutantGlioma24/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:

Patrick Y Wen, MD
Professor of Neurology
Harvard Medical School
Chief, Division of Neuro-Oncology
Dana-Farber Cancer Institute
Boston, Massachusetts

Advisory Committees: Alexion Pharmaceuticals, AstraZeneca Pharmaceuticals LP, Black Diamond Therapeutics Inc, Celularity, Chimerix, Day One Biopharmaceuticals, Fore Biotherapeutics, Genenta Science, GSK, Kintara Therapeutics, Merck, Nerviano Medical Sciences, Nuvation Bio; Contracted Research: AstraZeneca Pharmaceuticals LP, Black Diamond Therapeutics Inc, Bristol Myers Squibb, Chimerix, Erasca, Kazia Therapeutics Limited, Lilly, MediciNova, Merck, Novartis, Philogen; Data and Safety Monitoring Boards/Committees: Day One Biopharmaceuticals, Novocure; Speakers Bureaus: Peer Review; Nonrelevant Financial Relationships: Global Coalition for Adaptive Research, Med Learning Group, Medscape.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic 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, 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, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

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

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

These activities are supported by an educational grant from Servier Pharmaceuticals LLC.

Release date: June 2025
Expiration date: June 2026

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

Bhatia A et al. Tumor volume growth rates and doubling times during active surveillance of IDH-mutant low-grade glioma. Clin Cancer Res 2024;30(1):106-15. Abstract

Bunse L et al. Suppression of antitumor T cell immunity by the oncometabolite (R)-2-hydroxyglutarate. Nat Med 2018;24(8):1192-203. Abstract

de la Fuente MI et al. Olutasidenib (FT-2102) in patients with relapsed or refractory IDH1-mutant glioma: A multicenter, open-label, phase Ib/II trial. Neuro Oncol 2023;25(1):146-56. Abstract

Harvey-Jumper SL et al. Interactive effects of molecular, therapeutic, and patient factors on outcome of diffuse low-grade glioma. J Clin Oncol 2023;41(11):2029-42. Abstract

Lassman AB et al. Joint final report of EORTC 26951 and RTOG 9402: Phase III trials with procarbazine, lomustine, and vincristine chemotherapy for anaplastic oligodendroglial tumors. J Clin Oncol 2022;40(23):2539-45. Abstract

Mellinghoff IK et al. A global, randomized, double-blinded, phase 3 study of vorasidenib versus placebo in patients with adult-type diffuse glioma with an IDH1/2 mutation (INDIGO): Updated efficacy results. SNO 2024;Abstract CTNI-53.

Mellinghoff IK et al. Vorasidenib and ivosidenib in IDH1-mutant low-grade glioma: A randomized, perioperative phase 1 trial. Nat Med 2023;29(3):615-22. Abstract

Mellinghoff IK et al. Vorasidenib in IDH1- or IDH2-mutant low-grade glioma. N Engl J Med 2023;389(7):589-601. Abstract

Mellinghoff IK et al. Vorasidenib, a dual inhibitor of mutant IDH1/2, in recurrent or progressive glioma; Results of a first-in-human phase I trial. Clin Cancer Res 2021;27(16):4491-9. Abstract

Natsume A et al. The first-in-human phase I study of a brain-penetrant mutant IDH1 inhibitor DS-1001 in patients with recurrent or progressive IDH1-mutant gliomas. Neuro Oncol 2023;25(2):326-36. Abstract

Peters K et al. A randomized, double-blind, phase 3 study of vorasidenib versus placebo in patients with mutant IDH1/2 diffuse glioma (INDIGO): Analysis of health-related quality of life, neurocognition and seizures. AAN 2024;Abstract PL5.003.

Platten M et al. A vaccine targeting mutant IDH1 in newly diagnosed glioma. Nature 2021;592(7854):463-8. Abstract

Reuss DE et al. IDH mutant diffuse and anaplastic astrocytomas have similar age at presentation and little difference in survival: A grading problem for WHO. Acta Neuropathol 2015;129(6):867-73. Abstract

van den Bent MJ et al. The biological significance of tumor grade, age, enhancement, and extent of resection in IDH-mutant gliomas: How should they inform treatment decisions in the era of IDH inhibitors? Neuro Oncol 2024;26(10):1805-22. Abstract

Weller M et al. EANO guidelines on the diagnosis and treatment of diffuse gliomas of adulthood. Nat Rev Clin Oncol 2021;18(3):170-86. Abstract

Wen P et al. A phase 1, safety lead-in and randomized, open-label, perioperative study of vorasidenib combined with pembrolizumab in recurrent or progressive enhancing IDH-1 mutant glioma: Trial in progress. SNO 2023;Abstract CTIM-19.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, radiation oncologists, surgeons and other allied healthcare professionals involved in the treatment of multiple myeloma.

LEARNING OBJECTIVES

• Customize the selection of first-line therapy for newly diagnosed multiple myeloma (MM), considering new clinical research findings and patient- and disease-related factors, including cytogenetic profile and fitness for stem cell transplantation.
• Appreciate clinical trial data informing the front-line use of CD38-directed monoclonal antibody therapy for patients with MM eligible or ineligible for stem cell transplant, and effectively identify when and how this strategy should be integrated into disease management.
• Consider published research findings and other clinical factors in the best-practice sequencing of established and novel agents and regimens in the care of patients with relapsed/refractory MM.
• Evaluate published research information with chimeric antigen receptor T-cell therapy directed at B-cell maturation antigen (BCMA) as a targeted therapeutic strategy for MM, and identify patients for whom treatment with this novel approach should be considered or recommended.
• Assess available findings with available and investigational bispecific antibodies for MM, and recognize patients for whom treatment with one of these novel agents would be appropriate.
• Review recently presented research establishing the definitive efficacy of BCMA-directed antibody-drug conjugate therapy, and recognize the potential role of this form of treatment in clinical practice.
• Recall available research data with novel investigational agents and strategies for MM, and appropriately counsel patients about participation in relevant clinical trials.

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

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

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

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology 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 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/YiR2024/MM/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:

Meletios-Athanasios (Thanos) C Dimopoulos, MD
Professor and Chairman
Plasma Cell Dyscrasias Unit
Section of Hematology and Medical Oncology
Department of Clinical Therapeutics
School of Medicine
National and Kapodistrian University of Athens
Alexandra Hospital
Athens, Greece

Advisory Committees, Consulting Agreements and Speakers Bureaus: Amgen Inc, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, GSK, Janssen Biotech Inc, Menarini Group, Regeneron Pharmaceuticals Inc, Sanofi, Swixx Biopharma SA, Takeda Pharmaceutical Company Limited.

Robert Z Orlowski, MD, PhD
Florence Maude Thomas Cancer Research Professor
Department of Lymphoma and Myeloma
Professor, Department of Experimental Therapeutics
Vice Chair, Myeloma Translational Research
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, Texas

Advisory Committees and Consulting Agreements: AbbVie Inc, Adaptive Biotechnologies Corporation, Asylia Therapeutics Inc, Biotheryx, Bristol Myers Squibb, CellCentric, DEM BioPharma, IASO Bio, Karyopharm Therapeutics, Lytica Therapeutics, Meridian Therapeutics, Monte Rosa Therapeutics, MYELOMA360, Neoleukin Therapeutics Inc, Oncopeptides, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi, Takeda Pharmaceuticals USA Inc; Stock Options — Private Companies: Asylia 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, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic 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, 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, 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 GSK and Sanofi.

Release date: June 2025
Expiration date: June 2026

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

Ailawadhi S et al. Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: Updated KarMMa-3 analyses. Blood 2024;144(23):2389-401. Abstract

Badros A et al. Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: The AURIGA study. Blood 2025;145(3):300-10. Abstract

Bertamini L et al. Circulating tumor cells as a biomarker to identify high-risk transplant eligible myeloma patients treated with bortezomib, lenalidomide and dexamethasone with or without daratumumab during induction/consolidation, and lenalidomide with or without daratumumab during maintenance: Results from the Perseus study. ASH 2024;Abstract 487.

Cohen YC et al. Talquetamab plus teclistamab in relapsed or refractory multiple myeloma. N Engl J Med 2025;392(2):138-49. Abstract

Dimopoulos MA et al. Daratumumab or active monitoring for high-risk smoldering multiple myeloma. N Engl J Med 2025;392(18):1777-88. Abstract

Dimopoulos MA et al. Belantamab mafodotin, pomalidomide, and dexamethasone in multiple myeloma. N Engl J Med 2024;391(5):408-21. Abstract

Facon T et al. Isatuximab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med 2024;391(17):1597-609. Abstract

Freeman CL et al. Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Preliminary results from the IMMagine-1 trial. ASH 2024;Abstract 1031.

Garfall AL et al. Long-term follow-up from the phase 1/2 MajesTEC-1 trial of teclistamab in patients with relapsed/refractory multiple myeloma. ASCO 2024;Abstract 7540.

Hungria V et al. Belantamab mafodotin, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med 2024;391(5):393-407. Abstract

Hungria V et al. Belantamab mafodotin, bortezomib, and dexamethasone vs daratumumab, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma: Overall survival analysis and updated efficacy outcomes of the phase 3 Dreamm-7 trial. ASH 2024;Abstract 772.

Jurgens EM et al. Phase I trial of MCARH109, a G protein-coupled receptor class C group 5 member D (GPRC5D)-targeted chimeric antigen receptor T-cell therapy for multiple myeloma: An updated analysis. J Clin Oncol 2025;43(5):498-504. Abstract

Leleu X et al. Isatuximab, lenalidomide, dexamethasone and bortezomib in transplant-ineligible multiple myeloma: The randomized phase 3 BENEFIT trial. Nat Med 2024;30(8):2235-41. Abstract

Mai EK et al. Isatuximab, lenalidomide, bortezomib, and dexamethasone induction therapy for transplant-eligible newly diagnosed multiple myeloma: Final part 1 analysis of the GMMG-HD7 trial. J Clin Oncol 2025;43(11):1279-88. Abstract

Mateos M-V et al. Overall survival (OS) with ciltacabtagene autoleucel (cilta-cel) versus standard of care (SoC) in lenalidomide (len)-refractory multiple myeloma (MM): Phase 3 CARTITUDE-4 study update. IMS 2024;Abstract OA-65.

Pasquini MC et al. Minimal residual disease status in multiple myeloma 1 year after autologous hematopoietic cell transplantation and lenalidomide maintenance are associated with long-term overall survival. J Clin Oncol 2024;42(23):2757-68. Abstract

Prince HM et al. MagnetisMM-3: Long-term update and efficacy and safety of less frequent dosing of elranatamab in patients with relapsed or refractory multiple myeloma. ASH 2024;Abstract 4738.

Rasche L et al. Long-term efficacy and safety results from the Phase 1/2 MonumenTAL-1 study of talquetamab, a GPRC5D×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma. EHA 2024;Abstract P915.

Richardson PG et al. Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: Final overall survival analysis. Haematologica 2024;109(7):2239-49. Abstract

Sandhu I et al. Mezigdomide (MEZI) plus dexamethasone (DEX) and bortezomib (BORT) or carfilzomib (CFZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Updated results from the CC-92480-MM-002 trial. ASH 2024;Abstract 1025.

Shah MR et al. Linvoseltamab in patients with relapsed/refractory multiple myeloma: Longer follow-up and selected high-risk subgroup analyses of the Linker-MM1 study. ASH 2024;Abstract 3369.

Usmani SZ et al. Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: The randomized phase 3 CEPHEUS trial. Nat Med 2025;31(4):1195-202. Abstract

Usmani SZ et al. Phase I study of belantamab mafodotin in combination with standard of care in transplant-ineligible newly diagnosed multiple myeloma: Dreamm-9 updated interim analysis. ASH 2024;Abstract 497.

Yong K et al. Isatuximab plus carfilzomib-dexamethasone versus carfilzomib-dexamethasone in patients with relapsed multiple myeloma (IKEMA): Overall survival analysis of a phase 3, randomised, controlled trial. Lancet Haematol 2024;11(10):e741-50. Abstract

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, radiation oncologists, surgeons and other allied healthcare professionals involved in the treatment of multiple myeloma.

LEARNING OBJECTIVES

• Customize the selection of first-line therapy for newly diagnosed multiple myeloma (MM), considering new clinical research findings and patient- and disease-related factors, including cytogenetic profile and fitness for stem cell transplantation.
• Appreciate clinical trial data informing the front-line use of CD38-directed monoclonal antibody therapy for patients with MM eligible or ineligible for stem cell transplant, and effectively identify when and how this strategy should be integrated into disease management.
• Consider published research findings and other clinical factors in the best-practice sequencing of established and novel agents and regimens in the care of patients with relapsed/refractory MM.
• Develop an understanding of the mechanisms of action of and pivotal clinical trial findings with FDA-approved novel therapies to facilitate their integration into MM management algorithms.
• Evaluate the biological rationale for and published research information with chimeric antigen receptor T-cell therapy directed at B-cell maturation antigen (BCMA) as a targeted therapeutic strategy for MM, and identify patients for whom treatment with this novel approach should be considered or recommended.
• Assess available findings with BCMA- and non-BCMA-directed bispecific antibodies for MM, and recognize patients for whom treatment with one of these novel agents would be appropriate.
• Review recently presented research establishing the definitive efficacy of BCMA-directed antibody-drug conjugate therapy, and recognize the potential role of this form of treatment in clinical practice.
• Recall the mechanisms of action of and available research data with novel investigational agents and strategies for MM, and appropriately counsel patients about participation in relevant clinical trials.

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 1.25 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 this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.25 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 the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

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

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/YiR2024/MM/Presentations/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:

Meletios-Athanasios (Thanos) C Dimopoulos, MD
Professor and Chairman
Plasma Cell Dyscrasias Unit
Section of Hematology and Medical Oncology
Department of Clinical Therapeutics
School of Medicine
National and Kapodistrian University of Athens
Alexandra Hospital
Athens, Greece

Advisory Committees, Consulting Agreements and Speakers Bureaus: Amgen Inc, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, GSK, Janssen Biotech Inc, Menarini Group, Regeneron Pharmaceuticals Inc, Sanofi, Swixx Biopharma SA, Takeda Pharmaceutical Company Limited.

Robert Z Orlowski, MD, PhD
Florence Maude Thomas Cancer Research Professor
Department of Lymphoma and Myeloma
Professor, Department of Experimental Therapeutics
Vice Chair, Myeloma Translational Research
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, Texas

Advisory Committees and Consulting Agreements: AbbVie Inc, Adaptive Biotechnologies Corporation, Asylia Therapeutics Inc, Biotheryx, Bristol Myers Squibb, CellCentric, DEM BioPharma, IASO Bio, Karyopharm Therapeutics, Lytica Therapeutics, Meridian Therapeutics, Monte Rosa Therapeutics, MYELOMA360, Neoleukin Therapeutics Inc, Oncopeptides, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi, Takeda Pharmaceuticals USA Inc; Stock Options — Private Companies: Asylia 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, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic 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, 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, 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 GSK and Sanofi.

Release date: June 2025
Expiration date: June 2026

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

Ailawadhi S et al. Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: Updated KarMMa-3 analyses. Blood 2024;144(23):2389-401. Abstract

Badros A et al. Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: The AURIGA study. Blood 2025;145(3):300-10. Abstract

Bertamini L et al. Circulating tumor cells as a biomarker to identify high-risk transplant eligible myeloma patients treated with bortezomib, lenalidomide and dexamethasone with or without daratumumab during induction/consolidation, and lenalidomide with or without daratumumab during maintenance: Results from the Perseus study. ASH 2024;Abstract 487.

Cohen YC et al. Talquetamab plus teclistamab in relapsed or refractory multiple myeloma. N Engl J Med 2025;392(2):138-49. Abstract

Dimopoulos MA et al. Daratumumab or active monitoring for high-risk smoldering multiple myeloma. N Engl J Med 2025;392(18):1777-88. Abstract

Dimopoulos MA et al. Belantamab mafodotin, pomalidomide, and dexamethasone in multiple myeloma. N Engl J Med 2024;391(5):408-21. Abstract

Facon T et al. Isatuximab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med 2024;391(17):1597-609. Abstract

Freeman CL et al. Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Preliminary results from the IMMagine-1 trial. ASH 2024;Abstract 1031.

Garfall AL et al. Long-term follow-up from the phase 1/2 MajesTEC-1 trial of teclistamab in patients with relapsed/refractory multiple myeloma. ASCO 2024;Abstract 7540.

Hungria V et al. Belantamab mafodotin, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med 2024;391(5):393-407. Abstract

Hungria V et al. Belantamab mafodotin, bortezomib, and dexamethasone vs daratumumab, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma: Overall survival analysis and updated efficacy outcomes of the phase 3 Dreamm-7 trial. ASH 2024;Abstract 772.

Jurgens EM et al. Phase I trial of MCARH109, a G protein-coupled receptor class C group 5 member D (GPRC5D)-targeted chimeric antigen receptor T-cell therapy for multiple myeloma: An updated analysis. J Clin Oncol 2025;43(5):498-504. Abstract

Leleu X et al. Isatuximab, lenalidomide, dexamethasone and bortezomib in transplant-ineligible multiple myeloma: The randomized phase 3 BENEFIT trial. Nat Med 2024;30(8):2235-41. Abstract

Mai EK et al. Isatuximab, lenalidomide, bortezomib, and dexamethasone induction therapy for transplant-eligible newly diagnosed multiple myeloma: Final part 1 analysis of the GMMG-HD7 trial. J Clin Oncol 2025;43(11):1279-88. Abstract

Mateos M-V et al. Overall survival (OS) with ciltacabtagene autoleucel (cilta-cel) versus standard of care (SoC) in lenalidomide (len)-refractory multiple myeloma (MM): Phase 3 CARTITUDE-4 study update. IMS 2024;Abstract OA-65.

Pasquini MC et al. Minimal residual disease status in multiple myeloma 1 year after autologous hematopoietic cell transplantation and lenalidomide maintenance are associated with long-term overall survival. J Clin Oncol 2024;42(23):2757-68. Abstract

Prince HM et al. MagnetisMM-3: Long-term update and efficacy and safety of less frequent dosing of elranatamab in patients with relapsed or refractory multiple myeloma. ASH 2024;Abstract 4738.

Rasche L et al. Long-term efficacy and safety results from the Phase 1/2 MonumenTAL-1 study of talquetamab, a GPRC5D×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma. EHA 2024;Abstract P915.

Richardson PG et al. Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: Final overall survival analysis. Haematologica 2024;109(7):2239-49. Abstract

Sandhu I et al. Mezigdomide (MEZI) plus dexamethasone (DEX) and bortezomib (BORT) or carfilzomib (CFZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Updated results from the CC-92480-MM-002 trial. ASH 2024;Abstract 1025.

Shah MR et al. Linvoseltamab in patients with relapsed/refractory multiple myeloma: Longer follow-up and selected high-risk subgroup analyses of the Linker-MM1 study. ASH 2024;Abstract 3369.

Usmani SZ et al. Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: The randomized phase 3 CEPHEUS trial. Nat Med 2025;31(4):1195-202. Abstract

Usmani SZ et al. Phase I study of belantamab mafodotin in combination with standard of care in transplant-ineligible newly diagnosed multiple myeloma: Dreamm-9 updated interim analysis. ASH 2024;Abstract 497.

Yong K et al. Isatuximab plus carfilzomib-dexamethasone versus carfilzomib-dexamethasone in patients with relapsed multiple myeloma (IKEMA): Overall survival analysis of a phase 3, randomised, controlled trial. Lancet Haematol 2024;11(10):e741-50. 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

• Evaluate the efficacy of anti-PD-1/PD-L1 antibody therapy for muscle-invasive bladder cancer, and counsel patients about the current role of this treatment strategy.
• Consider the potential clinical role of circulating tumor DNA assessment to guide treatment decision-making and monitor for recurrence in nonmetastatic UBC.
• Review available clinical trial evidence with novel intravesical therapies under evaluation for nonmetastatic UBC, and determine the potential utility of these approaches for appropriately selected patients.
• Appreciate the biological rationale for combining anti-PD-1/PD-L1 antibodies with chemotherapy or other systemic agents with established efficacy in UBC, such as antibody-drug conjugates (ADCs), and discuss the current role of these regimens with patients about to begin first-line therapy.
• Recall pivotal clinical trial findings with novel compounds with unique mechanisms of action for previously treated locally advanced or metastatic UBC, such as ADCs and tyrosine kinase inhibitors, and identify patients for whom these approaches would be appropriate.

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

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

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

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

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation 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/ASCO2025/Bladder/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:

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.

Thomas Powles, MBBS, MRCP, MD
Director of Barts Cancer Institute
Queen Mary University of London
London, United Kingdom

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.

SURVEY PARTICIPANTS
Terence Friedlander, MD — 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, Pfizer Inc; Contracted Research: Bicycle Therapeutics, Genentech, a member of the Roche Group, Johnson & Johnson Pharmaceuticals, Pfizer Inc; Data and Safety Monitoring Boards/Committees: Bicycle Therapeutics. Petros Grivas, MD, PhD, FASCO — Consulting Agreements: AbbVie Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bicycle Therapeutics, Bristol Myers Squibb, Daiichi Sankyo Inc, EMD Serono Inc, Foundation Medicine, Fresenius Kabi AG, Gilead Sciences Inc, Janssen Biotech Inc, Lilly, Merck, Pfizer Inc, Replimune, Roche Laboratories Inc, Strata Oncology, UroGen Pharma; Contracted Research (Paid to Institution): Acrivon Therapeutics, ALX Oncology, Bristol Myers Squibb, EMD Serono Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Merck; Data and Safety Monitoring Boards/Committees: Bristol Myers Squibb, Strata Oncology. Jonathan E Rosenberg, MD — Advisory Committees: Astellas, Seagen Inc, Tyra Biosciences Inc; Consulting Agreements: Aadi Bioscience, Aktis Oncology, Alligator Bioscience, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, EMD Serono Inc, Genentech, a member of the Roche Group, Generate Biomedicines, Gilead Sciences Inc, Hengrui Therapeutics Inc, Imvax Inc, Janssen Biotech Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Pfizer Inc, Samsung Bioepis, Seagen Inc, Tyra Biosciences Inc; Contracted Research: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Seagen Inc.

MODERATOR
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.

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 Johnson & Johnson and Natera Inc.

Release date: June 2025
Expiration date: June 2026

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

Prof Powles

Galsky MD et al. Additional efficacy and safety outcomes and an exploratory analysis of the impact of pathological complete response (pCR) on long-term outcomes from NIAGARA. Genitourinary Cancers Symposium 2025;Abstract 659.

Milowsky M et al. Adjuvant nivolumab (NIVO) vs placebo (PBO) for high-risk muscle-invasive urothelial carcinoma (MIUC): Additional efficacy outcomes including overall survival (OS) in patients (pts) with muscle-invasive bladder cancer (MIBC) from CheckMate 274. Gastrointestinal Cancers Symposium 2025;Abstract 658.

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

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 TB et al. IMvigor011: A global, double-blind, randomised phase III study of atezolizumab (atezo; anti–PD-L1) vs placebo (pbo) as adjuvant therapy in patients (pts) with high-risk muscle-invasive bladder cancer (MIBC) who are circulating tumour (ct)DNA+ post cystectomy. ESMO 2021;Abstract 716TiP.

Powles TB et al. Clinical outcomes in post-operative ctDNA-positive muscle-invasive urothelial carcinoma (MIUC) patients after atezolizumab adjuvant therapy. ESMO 2020;Abstract 1O.

Sheng X et al. Neoadjuvant treatment with disitamab vedotin plus perioperative toripalimab in patients with muscle-invasive bladder cancer (MIBC) with HER2 expression: Updated efficacy and safety results from the phase II RC48-C017 trial. Genitourinary Cancers Symposium 2025;Abstract 665.

 

Prof Necchi

Bilen MA et al. Real-world (RW) treatment (Tx) patterns and clinical outcomes in patients (pts) with metastatic urothelial carcinoma (mUC) receiving first-line (1L) Tx: Results from IMPACT UC. ESMO 2021;Abstract 701P.

Catto JWF et al. Erdafitinib in BCG-treated high-risk non-muscle-invasive bladder cancer. Ann Oncol 2024;35(1):98-106. Abstract

Choi H et al. Health-related quality of life after radical cystectomy. Transl Androl Urol 2020;9(6):2997-3006. Abstract

Jeong S-H et al. Clinical determinants of recurrence in pTa bladder cancer following transurethral resection of bladder tumor. BMC Cancer 2022;22(1):631. 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(1):25-41. Abstract

Li R et al. Oncolytic immunotherapy with nivolumab in muscle-invasive bladder cancer: A phase 1b trial. Nat Med 2025;31(1):176-88. Abstract

Morgans AK et al. Treatment patterns among patients with advanced urothelial carcinoma (aUC) in the USA. ESMO 2021;Abstract 704P.

Necchi A et al. TAR-200 plus cetrelimab (CET) or CET alone as neoadjuvant therapy in patients (pts) with muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant cisplatin-based chemotherapy (NAC): Interim analysis of SunRISe-4 (SR-4). ESMO 2024;Abstract LBA84.

Rouprêt M et al. European Association of Urology guidelines on upper urinary tract urothelial carcinoma: 2020 update. Eur Urol 2021;79(1):62-79. Abstract

Shore ND et al. Non-muscle-invasive bladder cancer: An overview of potential new treatment options. Urol Oncol 2021;39(10):642-63. Abstract

Tyson M et al. Assessment of treatment patterns of nonmuscle invasive bladder cancer patients in privately insured patients. ASCO 2019;Abstract e16012.

Vilaseca A et al. First safety and efficacy results of the TAR-210 erdafitinib (erda) intravesical delivery system in patients (pts) with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations (alt). ESMO 2023;Abstract LBA104.

Westergren D-O et al. A nationwide, population based analysis of patients with organ confined, muscle invasive bladder cancer not receiving curative intent therapy in Sweden from 1997 to 2014. J Urol 2019;202(5):905-12. Abstract

 

Dr Galsky

Galsky MD et al. Preliminary efficacy and safety of disitamab vedotin (DV) with pembrolizumab (P) in treatment (Tx)-naive HER2-expressing, locally advanced or metastatic urothelial carcinoma (la/mUC): RC48G001 cohort C. ESMO 2024;Abstract 1967MO.

Loriot Y et al. Erdafitinib or chemotherapy in advanced or metastatic urothelial carcinoma. N Engl J Med 2023;389(21):1961-71. Abstract

Loriot Y et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma. N Engl J Med 2019;381(4):338-48. Abstract

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

Powles T et al. EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). Genitourinary Cancers Symposium 2025;Abstract 664.

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

Siefker-Radtke AO et al. Erdafitinib versus pembrolizumab in pretreated patients with advanced or metastatic urothelial cancer with select FGFR alterations: Cohort 2 of the randomized phase III THOR trial. Ann Oncol 2024;35(1):107-17. Abstract

Siefker-Radtke AO et al. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: Long-term follow-up of a phase 2 study. Lancet Oncol 2022;23(2):248-58. Abstract

van der Heijden MS et al. Nivolumab plus gemcitabine-cisplatin in advanced urothelial carcinoma. N Engl J Med 2023;389(19):1778-89. Abstract

Zhou L et al. Disitamab vedotin plus toripalimab in patients with locally advanced or metastatic urothelial carcinoma (RC48-C014): A phase Ib/II dose-escalation and dose-expansion study. Ann Oncol 2025;36(3):331-9. Abstract

Faculty

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

LEARNING OBJECTIVES

• Analyze the biological basis for the investigation of immune checkpoint inhibitors for localized non-small cell lung cancer (NSCLC), and evaluate available data documenting the efficacy and safety of anti-PD-1/PD-L1 antibodies as neoadjuvant and/or adjuvant therapy. 
• Appraise available findings from clinical studies and real-world analyses documenting long-term outcomes with anti-PD-L1 antibody consolidation therapy for patients with unresectable Stage III NSCLC who have not experienced disease progression after standard platinum-based chemotherapy concurrent with radiation therapy, and optimally integrate this treatment approach into patient care. 
• Consider recent therapeutic advances related to the use of anti-PD-1/PD-L1 antibodies as monotherapy or in combination with other systemic therapies for metastatic NSCLC, and discern how these approaches can be applied in the management of this disease. 
• Appreciate the incidence of targetable cell surface proteins, such as HER2, in patients with progressive metastatic NSCLC, and recognize published clinical trial data with and the optimal implementation of novel antibody-drug conjugates (ADCs). 
• Evaluate the biological rationale for targeting TROP2 in patients with NSCLC, and consider available research evidence with and the potential clinical role of TROP2-directed ADCs.

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

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 1.75 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 component and a 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, 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/ASCO2025/LungImmunoADC/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:

Marina Chiara Garassino, MBBS
Section of Hematology/Oncology
Professor of Medicine
Director, Thoracic Oncology Program
Department of Medicine
The University of Chicago
Chicago, Illinois

Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Daiichi Sankyo Inc, Gilead Sciences Inc, IO Biotech, Janssen Biotech Inc, Lilly, Merck, Mirati Therapeutics Inc, Natera Inc, Novocure Inc, Nuvation Bio, Pfizer Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines, Roche Laboratories Inc, Takeda Pharmaceuticals USA Inc.

John V Heymach, MD, PhD
Professor and Chair
Thoracic/Head and Neck Medical Oncology
The University of Texas MD Anderson Cancer Center
Houston, Texas

Advisory Committees: AbbVie Inc, AnHeart Therapeutics, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BioAtla, BioNTech SE, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Dizal, Ellipses Pharma, EMD Serono Inc, Genentech, a member of the Roche Group, GSK, Hengrui Therapeutics Inc, Janssen Biotech Inc, Leads Biolabs, Lilly, ModeX Therapeutics Inc, Novartis, Pfizer Inc, Regeneron Pharmaceuticals Inc, Remunity, Sanofi, Spectrum Pharmaceuticals Inc, Takeda Pharmaceuticals USA Inc; Research Support: AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Spectrum Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc; Royalties and Licensing Fees: Spectrum Pharmaceuticals Inc.

Professor Solange Peters, MD, PhD
Medical Oncology Director
Lausanne University Hospital
Lausanne, Switzerland

Advisory Committees and Consulting Agreements (All Fees to Institution): AbbVie Inc, Amgen Inc, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, BerGenBio ASA, Biocartis, BioInvent, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Daiichi Sankyo Inc, Debiopharm, Foundation Medicine, F-star Therapeutics Inc, Genentech, a member of the Roche Group, Genzyme Corporation, Gilead Sciences Inc, GSK, HUTCHMED, Illumina, Incyte Corporation, Ipsen Biopharmaceuticals Inc, iTeos Therapeutics, Janssen Biotech Inc, Lilly, Merck Serono, Merrimack Pharmaceuticals Inc, Mirati Therapeutics Inc, MSD, Novartis, Novocure Inc, Nykode Therapeutics, Pfizer Inc, PharmaMar, Promontory Therapeutics, Regeneron Pharmaceuticals Inc, Sanofi, Seagen Inc, Takeda Pharmaceutical Company Limited; Contracted Research (Institutional Support): Principal investigator for trials sponsored by Amgen Inc, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, Genentech, a member of the Roche Group, GSK, iTeos Therapeutics, Mirati Therapeutics Inc, MSD, PharmaMar, Promontory Therapeutics, Seagen Inc; Data and Safety Monitoring Board/Committee: AstraZeneca Pharmaceuticals LP; Speakers Bureaus (All Fees to Institution): AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Foundation Medicine, Genentech, a member of the Roche Group, GSK, Illumina, Ipsen Biopharmaceuticals Inc, Lilly, Mirati Therapeutics Inc, MSD, Novartis, Pfizer Inc, Sanofi, Takeda Pharmaceutical Company Limited.

MODERATOR
Jacob Sands, MD
Associate Chief, Thoracic Oncology
Dana-Farber Cancer Institute
Assistant Professor
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: AbbVie Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Curadev, Daiichi Sankyo Inc, Fosun Pharma, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Lilly, Mariana Oncology, Medtronic Inc, Merck, Novartis, Pfizer Inc, Sanofi, Summit Therapeutics; Contracted Research: Harpoon Therapeutics, Novartis; Data and Safety Monitoring Boards/Committees: Johnson & Johnson.

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

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

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

Release date: June 2025
Expiration date: June 2026

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

Prof Peters

Brahmer JR et al. Five-year survival outcomes with nivolumab (NIVO) plus ipilimumab (IPI) versus chemotherapy (chemo) as first-line (1L) treatment for metastatic non–small cell lung cancer (NSCLC): Results from CheckMate 227. ASCO 2024;Abstract LBA9025.

Carlisle JW et al. Bispecific antibodies in non-small cell lung cancer: From targeted innovation to real-world integration. Am Soc Clin Oncol Educ Book 2025;45(3). Abstract

Garon EB et al. A brief report of durvalumab with or without tremelimumab in combination with chemotherapy as first-line therapy for metastatic non-small-cell lung cancer: Outcomes by tumor PD-L1 expression in the phase 3 POSEIDON study. Clin Lung Cancer 2024;25(3):266-73. Abstract

Kilickap S et al. Cemiplimab monotherapy for first line advanced NSCLC patients with PD-L1 expression ≥50%: 5-y outcomes of EMPOWER-Lung. WCLC 2024;Abstract OA11.06.

Peters S et al. Treatment-free survival over 6 years of follow-up in patients with metastatic non-small cell lung cancer treated with first-line nivolumab plus ipilimumab versus chemotherapy in CheckMate 227 part 1. J Thorac Oncol 2025;[Online ahead of print]. Abstract

Zhou C et al. Four-year outcomes from GEMSTONE-302 study: First-line sugemalimab plus platinum-based chemotherapy in metastatic non-small cell lung cancer (NSCLC). ESMO 2024;Abstract 1318P.

 

Prof Garassino

Camidge DR et al. Telisotuzumab vedotin monotherapy in patients with previously treated c-Met–overexpressing advanced non-small cell lung cancer. ASCO 2022;Abstract 9016.

Girard N et al. Preventing moderate to severe dermatologic adverse events in first-line EGFR-mutant advanced NSCLC treated with amivantamab plus lazertinib: Early success of the COCOON trial. ELCC 2025;Abstract 10MO.

Janne PA et al. Trastuzumab deruxtecan (T-DXd) in patients with HER2-mutant metastatic non–small cell lung cancer (mNSCLC): Final analysis results of DESTINY-Lung02. ASCO 2024;Abstract 8543.

Le X et al. METPRO: Evaluating prognostic value of c-Met protein overexpression and concurrent biomarker presence. ESMO 2024;Abstract 1303P.

Lu S et al. A phase 3 global study of telisotuzumab vedotin versus docetaxel in previously treated patients with c-Met 0verexpressing, EGFR wildtype, locally advanced/metastatic nonsquamous NSCLC (TeliMET NSCLC-01). ASCO 2024;Abstract TPS8656.

Planchard D et al. Trastuzumab deruxtecan monotherapy in pretreated HER2-overexpressing nonsquamous non-small cell lung cancer: DESTINY-Lung03 part 1. WCLC 2024;Abstract OA16.05.

 

Dr Sands

Ahn SG et al. A prognostic value of BCT gene score in ER+HER2- breast cancer patients with 21-gene recurrence score. ESMO Asia 2024;Abstract 10.

Garassino MC et al. Normalized membrane ratio of TROP2 by quantitative continuous scoring is predictive of clinical outcomes in TROPION-Lung 01. WCLC 2024;Abstract PL02.11.

Levy BP et al. TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC). ASCO 2025;Abstract 8501.

Paz-Ares LG et al. Sacituzumab govitecan versus docetaxel for previously treated advanced or metastatic non-small cell lung cancer: The randomized, open-label phase III EVOKE-01 study. J Clin Oncol 2024;42(24):2860-72. Abstract

Sands J et al. Datopotamab deruxtecan vs docetaxel in patients with non-small cell lung cancer: Final overall survival from TROPION-Lung01. WCLC 2024;Abstract OA08.03.

Zhao S et al. Sacituzumab tirumotecan in advanced non-small-cell lung cancer with or without EGFR mutations: Phase 1/2 and phase 2 trials. Nat Med 2025;[Online ahead of print]. Abstract

 

Dr Heymach

Cascone T et al. Neocoast-2: Efficacy and safety of neoadjuvant durvalumab (D) + novel anticancer agents + CT and adjuvant D ± novel agents in resectable NSCLC. IASLC 2024;Abstract PL02.07.

Cascone T et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med 2024;390(19):1756-69. Abstract

Forde PM et al. Perioperative vs neoadjuvant nivolumab for resectable NSCLC: Patient-level data analysis of CheckMate 77T vs CheckMate 816. WCLC 2024;Abstract PL02.08.

Faculty

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

LEARNING OBJECTIVES

• Appreciate the prevalence and relevance of HER2 amplification and overexpression in various GI cancers, and consider the implications for biomarker assessment and clinical management.
• Evaluate available clinical trial findings with HER2-directed therapies for HER2-positive biliary tract cancers, and optimally incorporate recently approved agents into the care of appropriately selected patients.
• Review published research findings with established HER2-targeted therapies for patients with HER2-positive gastroesophageal cancers, and assess the current role of various agents and regimens outside of a research setting.
• Recall available data with HER2-targeted agents and strategies for previously treated HER2-overexpressing colorectal cancer, and optimally identify patients for whom these approaches may be appropriate.
• Understand the biological rationale for and available clinical trial findings with novel HER2-directed bispecific antibodies for patients with HER2-positive GI cancers, and contemplate the current and potential utility of these agents in the management of various diseases.
• Appraise the side effects associated with available HER2-directed therapies with established efficacy for GI cancers, and use this information to develop supportive care plans for patients undergoing treatment with these agents or regimens.
• Recall the design of ongoing clinical trials evaluating HER2-directed agents and strategies for advanced HER2-positive GI cancers, and appropriately counsel patients about availability and participation.

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

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 1.75 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 component and a 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, 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/ASCO2025/HER2GI/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:

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.

Sara Lonardi, MD
Director of the Oncology 1 Unit
Veneto Institute of Oncology IOV-IRCCS
Padua, Italy

No relevant financial relationships to disclose.

Kanwal Raghav, MD, MBBS
Associate Professor, Gastrointestinal Medical Oncology
Associate Vice President (AVP), Ambulatory Medical Operations
Executive Medical Director (EMD), Ambulatory Treatment Centers
The University of Texas MD Anderson Cancer Center
Houston, Texas

Advisory Committees and Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Eisai Inc, Guardant Health, Janssen Biotech Inc, Merck, Pfizer Inc; Data and Safety Monitoring Boards/Committees: AbbVie Inc, Pfizer Inc.

MODERATOR
Christopher Lieu, MD
Professor of Medicine
Associate Director for Clinical Research
Co-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 AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, and Jazz Pharmaceuticals Inc.

Release date: June 2025
Expiration date: June 2026

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

Dr Lonardi

Cancer Genome Atlas Network. Integrated genomic characterization of oesophageal carcinoma. Nature 2017;541(7636):169-75. Abstract

Elimova E et al. Zanidatamab + chemotherapy for first-line (1L) treatment of HER2+ advanced or metastatic gastro-oesophageal adenocarcinoma (mGEA): New and updated data from a phase II trial. ESMO 2024;Abstract 1423P.

Fassan M et al. Current prognostic and predictive biomarkers for gastrointestinal tumors in clinical practice. Pathologica 2020;112(3):248-59. 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.

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

Shitara K et al. Negative hyperselection of patients with RAS wild-type metastatic colorectal cancer for panitumumab: A biomarker study of the phase III PARADIGM trial. Gastrointestinal Cancers Symposium 2022;Abstract 11.

Shitara K et al. Trastuzumab deruxtecan in previously treated HER2-positive gastric cancer. N Engl J Med 2020;382(25):2419-30. Abstract

Van Cutsem E et al. Trastuzumab deruxtecan in patients in the USA and Europe with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after a trastuzumab-containing regimen (DESTINY-Gastric02): Primary and updated analyses from a single-arm, phase 2 study. Lancet Oncol 2023;24(7):744-56. Abstract

Wilke H et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): A double-blind, randomised phase 3 trial. Lancet Oncol 2014;15(11):1224-35. Abstract

Yamaguchi K et al. Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2–positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: Final overall survival (OS) results from a randomized, multicenter, open-label, phase 2 study (DESTINY-Gastric01). Gastrointestinal Cancers Symposium 2022;Abstract 242.

Zhao D et al. Progress and challenges in HER2-positive gastroesophageal adenocarcinoma. J Hematol Oncol 2019;12(1):50. Abstract

 

Dr Ellis

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.

Harding JJ et al. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): A multicentre, single-arm, phase 2b study. Lancet Oncol 2023;24(7):772-82. Abstract

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.

Jacobi O et al. ERBB2 pathway in biliary tract carcinoma: Clinical implications of a targetable pathway. Oncol Res Treat 2021;44(1-2):20-7. Abstract

Kehmann L et al. Evolving therapeutic landscape of advanced biliary tract cancer: From chemotherapy to molecular targets. ESMO Open 2024;9(10). 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-K 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;[Online ahead of print]. Abstract

Oh D-Y et al. Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-expressing biliary tract cancer (BTC) and pancreatic cancer (PC): Outcomes from DESTINY-PanTumor02 (DP-02). ASCO 2024;Abstract 4090.

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 previously-treated HER2-positive (HER2+) biliary tract cancer (BTC): Overall survival (OS) and longer follow-up from the phase 2b HERIZON-BTC-01 study. ASCO 2024;Abstract 4091.

Søreide K et al. Pancreatic cancer. Eur J Surg Oncol 2023;49(2):521-5. Abstract

 

Dr Raghav

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

Raghav KPS et al. Trastuzumab plus pertuzumab versus cetuximab plus irinotecan in patients with RAS/BRAF wild-type, HER2-positive, metastatic colorectal cancer (S1613): A randomized phase II trial. J Clin Oncol 2025;43(11):1348-57. Abstract

Raghav KPS 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

Raghav KPS, Moasser MM. Molecular pathways and mechanisms of HER2 in cancer therapy. Clin Cancer Res 2023;29(13):2351-61. Abstract

Rha SY et al. EDGE-Gastric arm A1: Phase II study of domvanalimab (D), zimberelimab (Z), and FOLFOX in first-line (1L) advanced gastroesophageal (GE) cancer. ESMO 2024;Abstract 130MO.

Siena S et al. Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): A multicentre, open-label, phase 2 trial. Lancet Oncol 2021;22(6):779-89. 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.

Strickler JH et al. Tucatinib plus trastuzumab for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer (MOUNTAINEER): A multicentre, open-label, phase 2 study. Lancet Oncol 2023;24(5):496-508. Abstract