Faculty

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

LEARNING OBJECTIVES

• Evaluate recently presented clinical research findings to determine their effect on the current management of metastatic breast cancer (mBC).
• Review the correlation between various biomarkers (eg, PIK3CA/AKT1/PTEN alterations, ESR1 mutations, low and ultralow HER2 levels) and response to specific therapies, and develop optimal testing algorithms for patients with hormone receptor (HR)-positive mBC.
• Appraise published efficacy and safety data from randomized clinical trials evaluating CDK4/6 inhibitors for HR-positive mBC, and appropriately counsel patients regarding the optimal use of these agents.
• Recall the frequency of phosphoinositide-3 kinase pathway mutations in patients with HR-positive mBC, and recognize the evidence-based approaches available to target these aberrations in individuals with PIK3CA-mutated disease.
• Understand the mechanism of action of, published and emerging research findings with and the current and future clinical role of oral selective estrogen receptor degraders for patients with HR-positive mBC harboring ESR1 mutations.
• Interrogate published Phase III research documenting the efficacy of AKT inhibitors for patients with progressive HR-positive mBC to determine the current clinical applicability of this approach.
• Appreciate the incidence, characteristics and clinical relevance of HER2-low or ultralow mBC, and understand available research findings with HER2-directed antibody-drug conjugates for this disease subset.
• Assess published and emerging Phase III research documenting the efficacy of TROP2-directed antibody-drug conjugates for mBC in order to determine the current and potential clinical applicability of these approaches.
• Evaluate published and emerging research findings and biological and clinical factors to effectively select and sequence available therapeutic agents and regimens for patients with HER2-positive mBC.
• Review published research supporting the use of chemotherapy in combination with anti-PD-1/PD-L1 antibodies for patients with triple-negative mBC, and use this information to make appropriate treatment recommendations.
• Discuss available research establishing the efficacy of PARP inhibitors for patients with mBC harboring BRCA or other homologous recombination repair pathway mutations, and identify individuals appropriate for treatment with these agents.
• Recall the mechanisms of action of, early data with and ongoing clinical trials evaluating other novel agents and treatment strategies under development for mBC.

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

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

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

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

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

Harold J Burstein, MD, PhD
Director of Academic Partnerships
Institute Physician
Dana-Farber Cancer Institute
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

No relevant financial relationships to disclose

Javier Cortés, MD, PhD
Head, IBCC International Breast Cancer Center
Barcelona, Spain

Consulting and Advisor: AbbVie Inc, AstraZeneca Pharmaceuticals LP, AvenCell Europe GmbH, Bioasis Technologies Inc, Biocon, BioInvent, BioNTech SE, Bliss Biopharmaceutical (Hangzhou) Co Ltd, Boehringer Ingelheim Pharmaceuticals Inc, Circle Pharma, Daiichi Sankyo Inc, Delcath Systems Inc, Ellipses Pharma, ExpreS2ion Biotechnologies, Gilead Sciences Inc, Hexagon Bio, HiberCell, Jazz Pharmaceuticals Inc, Leuko Labs Inc, Lilly, Menarini Group, MSD, pharmaand GmbH, QED Therapeutics, Reveal Genomics, Roche Laboratories Inc, Seagen Inc, Zymeworks Inc; Contracted Research Funding to Institution: AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Eisai Inc, F Hoffmann-La Roche Ltd, Guardant Health, IQVIA, MSD, Pfizer Inc, PIQUR Therapeutics, Queen Mary University of London, Roche Laboratories Inc, Servier Affaires Medicales, Takeda Pharmaceuticals USA Inc; Honoraria: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Eisai Inc, Gilead Sciences Inc, Lilly, MSD, Novartis, Pfizer Inc, Roche Laboratories Inc, Stemline Therapeutics Inc, Zuellig Pharma; Patents: WO 2014/199294 A, US 2019/0338368 A1; Stock Options/Stock — Public Companies: Leuko Labs Inc; Travel, Accommodation, Expenses: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Eisai Inc, Gilead Sciences Inc, MSD, Novartis, Pfizer Inc, Roche Laboratories Inc, Stemline Therapeutics Inc; Nonrelevant Financial Relationships: MAJ3 Capital.

Rebecca A Dent, MD, MSc
Senior Consultant
National Cancer Centre Singapore
Singapore

No relevant financial relationships to disclose.

Kevin Kalinsky, MD, MS, FASCO
Professor of Medicine
Director, Division of Medical Oncology
Director, Glenn Family Breast Center
Winship Cancer Institute at Emory University
Atlanta, Georgia

Advisory Committees: AstraZeneca Pharmaceuticals LP, Biotheranostics Inc, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Silicon Biosystems, Merck, Mersana Therapeutics Inc, Myovant Sciences, Novartis, Pfizer Inc, ProteinQure, Puma Biotechnology Inc, Regor Therapeutics, Relay Therapeutics, Seagen Inc.

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

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

SURVEY PARTICIPANTS
Sara A Hurvitz, MD, FACP — Contracted Research: Ambrx, Amgen Inc, Arvinas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Celcuity, CytomX Therapeutics, Daiichi Sankyo Inc, Dantari, Dignitana AB, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Greenwich LifeSciences Inc, GSK, Lilly, MacroGenics Inc, Novartis, OBI Pharma Inc, Orinove Inc, Orum Therapeutics, Pfizer Inc, Phoenix Molecular Designs, Pieris Pharmaceuticals Inc, Puma Biotechnology Inc, Radius Health Inc, Samumed, Sanofi, Seagen Inc, Stemline Therapeutics Inc, Zymeworks Inc. Komal Jhaveri, MD, FACP — Consultant/Advisory Board Roles: AstraZeneca Pharmaceuticals LP, Bicycle Therapeutics, Blueprint Medicines, Daiichi Sankyo Inc, Eisai Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Menarini Group, Novartis, Olema Oncology, Pfizer Inc, RayzeBio Inc, Scorpion Therapeutics, Stemline Therapeutics Inc, Zymeworks Inc; Research Funding (Support to Institution): AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Eisai Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Novartis, Pfizer Inc, Puma Biotechnology Inc, RayzeBio Inc, Scorpion Therapeutics, Zymeworks Inc; Travel and Accommodations: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Pfizer Inc.

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

Advisory Committees: Bristol Myers Squibb, Chugai Pharmaceutical Co Ltd, Napo Pharmaceuticals Inc, Sanofi, Viatris; Contracted Research (Institutional Research Support): Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, OBI Pharma Inc, Pfizer Inc, Stemline Therapeutics 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 AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Puma Biotechnology Inc, and Stemline Therapeutics 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 Cortés

Altaha R et al. Increased risk of brain metastases in patients with HER-2/neu-positive breast carcinoma. Cancer 2005;103(3):442-3. Abstract

Baselga J et al. Case records of the Massachusetts General Hospital. Case 16-2012. A 32-year-old woman with HER2-positive breast cancer. N Engl J Med 2012;366(21):2018-26. Abstract

Bose R et al. Activating HER2 mutations in HER2 gene amplification negative breast cancer. Cancer Discov 2013;3(2):224-37. Abstract

Brufsky A et al. Phase II COLET study: Atezolizumab (A) + cobimetinib (C) + paclitaxel (P)/nab-paclitaxel (nP) as first-line (1L) treatment (tx) for patients (pts) with locally advanced or metastatic triple-negative breast cancer (mTNBC). ASCO 2019;Abstract 1013.

Cortés J et al. Pembrolizumab plus chemotherapy in advanced triple-negative breast cancer. N Engl J Med 2022;387(3):217-26. Abstract

Hyman DM et al. HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature 2018;554(7691):189-94. Abstract

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

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

Martin M et al. Brain metastases from non-small cell lung carcinoma: An overview of classical and novel treatment strategies. Rep Pract Oncol Radiother 2022;27(3):527-44. Abstract

Metzger O et al. PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs. anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor-positive (HR+)/HER2-positive metastatic breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract AFT-38.

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

Olson EM et al. Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era. Breast 2013;22(4):525-31. Abstract

Rugo HS et al. SOPHIA primary analysis: A phase 3 (P3) study of margetuximab (M) + chemotherapy (C) versus trastuzumab (T) + C in patients (pts) with HER2+ metastatic (met) breast cancer (MBC) after prior anti-HER2 therapies (Tx). ASCO 2019;Abstract 1000.

Tolaney S et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. ASCO 2025;Abstract LBA1008.

Verma S et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012;367(19):1783-91. Abstract

 

Dr Kalinsky

Allouchery V et al. Circulating ESR1 mutations at the end of aromatase inhibitor adjuvant treatment and after relapse in breast cancer patients. Breast Cancer Res 2018;20(1):40. Abstract

Bardia A et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Primary results from the randomised phase III TROPION-Breast01 trial. ESMO 2023;Abstract LBA11.

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

Brufsky AM. Long-term management of patients with hormone receptor-positive metastatic breast cancer: Concepts for sequential and combination endocrine-based therapies. Cancer Treat Rev 2017;59:22-32. Abstract

Cabel L et al. Dynamics and type of ESR1 mutations under aromatase inhibitor or fulvestrant combined with palbociclib after randomization in the PADA-1 trial. ASCO 2023;Abstract 1002.

Carlson RW et al. Phase II trial of anastrozole plus goserelin in the treatment of hormone receptor-positive, metastatic carcinoma of the breast in premenopausal women. J Clin Oncol 2010;28(25):3917-21. Abstract

Croxtall JD et al. Fulvestrant: A review of its use in the management of hormone receptor-positive metastatic breast cancer in postmenopausal women. Drugs 2011;71(3):363-80. Abstract

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

Jeselsohn R et al. Allele-specific chromatin recruitment and therapeutic vulnerabilities of ESR1 activating mutations. Cancer Cell 2018;33(2):173-86.e5. Abstract

Jeselsohn R et al. Emergence of constitutively active estrogen receptor-α mutations in pretreated advanced estrogen receptor-positive breast cancer. Clin Cancer Res 2014;20(7):1757-67. Abstract

Lim E et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park) 2012;26(8):688-94, 696. Abstract

Rugo HS et al. Capivasertib (C) and fulvestrant (F) for patients (pts) with aromatase inhibitor (AI)-resistant HR+/HER2– advanced breast cancer (ABC): Characterization and management of common adverse events (AEs) from the phase 3 CAPItello-291 trial. ASCO 2023;Abstract 1067.

Rugo HS et al. Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer. Ann Oncol 2020;31(8):1001-10. Abstract

Schiavon G et al. Analysis of ESR1 mutation in circulating tumor DNA demonstrates evolution during therapy for metastatic breast cancer. Sci Transl Med 2015;7(313):313ra182. Abstract

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

Vasan N et al. At a crossroads: how to translate the roles of PI3K in oncogenic and metabolic signalling into improvements in cancer therapy. Nat Rev Clin Oncol 2022;19(7):471-85. Abstract

 

Dr Burstein

Bardia A et al. Elacestrant in ER+, HER2- metastatic breast cancer with ESR1-mutated tumors: Subgroup analyses from the phase III EMERALD trial by prior duration of endocrine therapy plus CDK4/6 inhibitor and in clinical subgroups. Clin Cancer Res 2024;30(19):4299-309. Abstract

Bardia A et al. Elacestrant vs standard-of-care in ER+/HER2- advanced or metastatic breast cancer (mBC) with ESR1 mutation: Key biomarkers and clinical subgroup analyses from the phase 3 EMERALD trial. San Antonio Breast Cancer Symposium 2023;Abstract PS17-02.

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

Hamilton EP et al. Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer: Results of the global, randomized, phase 3 VERITAC-2 study. ASCO 2025;Abstract LBA1000.

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

Jhaveri K et al. Imlunestrant, an oral selective estrogen receptor degrader (SERD), as monotherapy & combined with abemaciclib, for patients with ER+, HER2- advanced breast cancer (ABC), pretreated with endocrine therapy (ET): Results of the phase 3 EMBER-3 trial. San Antonio Breast Cancer Symposium 2024;Abstract GS1-01.

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

 

Dr O’Shaughnessy

Banerji U et al. Trastuzumab duocarmazine in locally advanced and metastatic solid tumours and HER2-expressing breast cancer: A phase 1 dose-escalation and dose-expansion study. Lancet Oncol 2019;20(8):1124-35. Abstract

Bardia A et al. Efficacy and safety of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) by pace of disease progression on prior endocrine-based therapy: Additional analysis from DESTINY-Breast06. San Antonio Breast Cancer Symposium 2024;Abstract LB1-04.

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

Geukens T et al. Intra-patient and inter-metastasis heterogeneity of HER2-low status in metastatic breast cancer. Eur J Cancer 2023;188:152-60. Abstract

Hurvitz SA et al. TRIO-US B-12 TALENT: Neoadjuvant trastuzumab deruxtecan with or without anastrozole for HER2-low, HR+ early-stage breast cancer. San Antonio Breast Cancer Symposium 2022;Abstract GS2-03.

Miglietta F et al. Evolution of HER2-low expression from primary to recurrent breast cancer. NPJ Breast Cancer 2021;7(1):137. Abstract

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

Modi S et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med 2022;387(1):9-20. Abstract

Modi S et al. Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Results of DESTINY-Breast04, a randomized, phase 3 study. ASCO 2022;Abstract LBA3.

O’Shaughnessy J et al. DYNASTY-Breast02: A phase III trial of BNT323/DB-1303 vs investigator’s choice chemotherapy in HER2-low, hormone receptor positive, metastatic breast cancer. ESMO 2024;Abstract 436TiP.

Tarantino P et al. Evolution of low HER2 expression between early and advanced-stage breast cancer. Eur J Cancer 2022;163:35-43. Abstract

Wang J et al. RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic breast cancer: A pooled analysis of two studies. ASCO 2021;Abstract 1022.

 

Dr Rugo

Bardia A et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer: Primary results from TROPION-Breast01. J Clin Oncol 2025;43(3):285-96. Abstract

Bardia A et al. Randomized phase 3 study of datopotamab deruxtecan vs chemotherapy for patients with previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer: Results from TROPION-Breast01. San Antonio Breast Cancer Symposium 2023;Abstract GS02-01.

Columbo R et al. The journey of antibody–drug conjugates: lessons learned from 40 years of development. Cancer Discov 2024;14(11):2089-108. Abstract

Hamilton E et al. Initial phase 1 dose escalation data for emiltatug ledadotin (Emi-Le), a novel B7-H4-directed dolasynthen antibody-drug conjugate. ASCO 2025;Abstract 3009.

Nelson RS et al. UGT1A1 guided cancer therapy: Review of the evidence and considerations for clinical implementation. Cancers (Basel) 2021;13(7):1566. Abstract

Pérez-García JM et al. Prevention of sacituzumab govitecan (SG)-related neutropenia and diarrhea in patients (pts) with triple-negative or HR+/HER2- advanced breast cancer (ABC; PRIMED): A phase 2 trial. ASCO 2024;Abstract 1101.

Pistilli B et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Final overall survival (OS) from the phase III TROPION-Breast01 trial. ESMO 2025;VP1-2025.

Rugo HS et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): A randomised, open-label, multicentre, phase 3 trial. Lancet 2023;402(10411):1423-33. Abstract

Rugo HS et al. Health-related quality of life (HRQoL) in the phase III TROPiCS-02 trial of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (MBC). ESMO 2022;Abstract 1553O. 

Rugo HS et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2022;40(29):3365-76. Abstract

Rugo HS et al. Sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC): Efficacy by Trop-2 expression in the TROPiCS-02 study of patients (pts) with HR+/HER2– metastatic breast cancer (mBC). San Antonio Breast Cancer Symposium 2022;Abstract GS1-11.

Rugo HS et al. Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer. NPJ Breast Cancer 2022;8(1):98. Abstract

Tolaney SM et al. Final overall survival (OS) analysis from the phase 3 TROPiCS-02 study of sacituzumab govitecan (SG) in patients (pts) with hormone receptor–positive/HER2-negative (HR+/HER2–) metastatic breast cancer (mBC). ASCO 2023;Abstract 1003. 

 

Prof Dent

Bardia A et al. Datopotamab deruxtecan in advanced or metastatic HR+/HER2- and triple-negative breast cancer: Results from the phase I TROPION-PanTumor01 study. J Clin Oncol 2024;42(19):2281-94. Abstract

Bardia A et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med 2021;384(16):1529-41. Abstract

Binghe Xu et al. Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. ASCO 2024;Abstract 104.

Cortes J et al. Pembrolizumab plus chemotherapy in advanced triple-negative breast cancer. N Engl J Med 2022;387(3):217-26. Abstract

Dent R et al. IMpassion132 double-blind randomised phase III trial of chemotherapy with or without atezolizumab for early relapsing unresectable locally advanced or metastatic triple-negative breast cancer. Ann Oncol 2024;35(7):630-42. Abstract

Giordano A et al. Enfortumab vedotin (EV) in triple-negative breast cancer (TNBC) and HR+/HER2- breast cancer (BC) cohorts of EV-202. ASCO 2024;Abstract 1005.

Krop IE et al. Results from the phase 1/2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC). ASCO 2022;Abstract 1002.

Litton JK et al. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: Final overall survival results from the EMBRACA trial. Ann Oncol 2020;31(11):1526-35. Abstract

Litton JK et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med 2018;379(8):753-63. Abstract

Robson ME et al. OlympiAD extended follow-up for overall survival and safety: Olaparib versus chemotherapy treatment of physician’s choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Eur J Cancer 2023;184:39-47. Abstract

Robson M et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med 2017;377(6):523-33. Abstract

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

Tung N et al. TBCRC 031: Randomized phase II study of neoadjuvant cisplatin versus doxorubicin-cyclophosphamide in germline BRCA carriers with HER2-negative breast cancer (the INFORM trial). J Clin Oncol 2020;38(14):1539-48. Abstract

Yin Y et al. Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: a randomized phase 3 trial. Nat Med 2025;[Online ahead of print]. Abstract

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

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 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 activity has been designed to meet the educational needs of oncology nurses, nurse practitioners and clinical nurse specialists involved in the treatment of prostate cancer.

PURPOSE STATEMENT
By providing information on the latest research developments in the context of expert perspectives, this NCPD activity will assist oncology nurses, nurse practitioners and clinical nurse specialists with the formulation of state-of-the-art clinical management strategies to facilitate optimal care of patients with prostate cancer.

LEARNING OBJECTIVES

• Understand how age, comorbidities, prior therapeutic exposure and other clinical and biological factors affect the selection and sequencing of available hormonal agents for patients with prostate cancer.
• Assess the available research supporting the use of PARP inhibitors as monotherapy or in combination with androgen receptor pathway inhibitors for patients with metastatic castration-resistant prostate cancer (mCRPC) harboring a homologous recombination repair gene alteration.
• Understand the biological rationale and mechanism of action for approved radiopharmaceuticals used for mCRPC.
• Review relevant counseling points for patients receiving radiopharmaceuticals for the treatment of prostate cancer.
• Implement a plan of care to recognize and manage side effects and toxicities associated with approved therapies for prostate cancer.

ACCREDITATION STATEMENT
Research To Practice (RTP) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.

CREDIT DESIGNATION STATEMENT
This educational activity for 1 contact hour is provided by RTP during the period of June 2025 to June 2026.

This activity is awarded 1 ANCC pharmacotherapeutic contact hour.

ONCC/ILNA CERTIFICATION INFORMATION
The program content has been reviewed by the ONCC and is acceptable for recertification points. Learners must apply for NCPD credit to utilize this program for ONCC certification or renewal. To review certification qualifications please visit https://www.researchtopractice.com/Meetings/ONS2025/Review/Prostate/ILNA.

ONCC review is only for designating content to be used for ILNA points and is not for NCPD accreditation. NCPD programs must be formally approved for contact hours by an acceptable accreditor/approver of nursing CE to be used for recertification by ONCC. If the NCPD provider fails to obtain formal approval to award contact hours by an acceptable accrediting/approval body, no information related to ONCC recertification or ILNA categories may be used in relation to the program.

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.

FOR SUCCESSFUL COMPLETION
Video Program: This NCPD activity consists of a video component. To receive credit, the participant should review the NCPD information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/ONS2025/Review/Prostate/Video/NCPD.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess financial relationships with faculty, planners and managers of NCPD activities. Financial relationships are identified and resolved through a financial relationship resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent nurse reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

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

Kathleen D Burns, RN, MSN, AGACNP-BC, OCN
Genitourinary Medical Oncology
City of Hope Comprehensive Cancer Center
Duarte, California

Advisory Committees: Eisai Inc, Janssen Biotech Inc, Sumitomo Dainippon Pharma Oncology Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Exelixis Inc, Pfizer Inc, Sumitomo Dainippon Pharma Oncology Inc.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop NCPD 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 NCPD 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 Astellas and Pfizer Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Johnson & Johnson, Merck, and Novartis.

Release date: June 2025
Expiration date: June 2026

There is no implied or real endorsement of any product by RTP or the American Nurses Credentialing Center.

References from Understanding the Current Paradigm and New Approaches in the Care of Patients with Prostate Cancer (Symposium Video Proceedings)

Dr Aggarwal

Module 1: Recent Advances in the Treatment of Nonmetastatic Prostate Cancer

Chi KN et al. Phase 3 MAGNITUDE study: First results of niraparib (NIRA) with abiraterone acetate and prednisone (AAP) as first-line therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with and without homologous recombination repair (HRR) gene alterations. Genitourinary Cancers Symposium 2022;Abstract 12.

Freedland SJ et al. Improved outcomes with enzalutamide in biochemically recurrent prostate cancer. N Engl J Med 2023;389(16):1453-65. Abstract

Freedland SJ et al. Risk of prostate cancer-specific mortality following biochemical recurrence after radical prostatectomy. JAMA 2005;294(4):433-9. Abstract

Scher HI et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: Recommendations of the prostate cancer clinical trials working group. J Clin Oncol 2008;26(7):1148-59. Abstract

 

Module 4: Current and Future Role of Radiopharmaceuticals in mCRPC

Gillessen S et al. A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of Radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): First results of EORTC-GUCG 1333/PEACE-3. ESMO 2024;Abstract LBA1.

Morris MJ et al. Phase III study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION). ASCO 2021;Abstract LBA4.

Parker C et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 2013;369(3):213-23. Abstract

Sartor O et al. Phase III trial of [177Lu]Lu-PSMA-617 in taxane-naive patients with metastatic castration-resistant prostate cancer (PSMAfore). ESMO 2023;Abstract LBA13.

 

Dr Oh

Module 2: Treatment Approaches for Metastatic Hormone-Sensitive Prostate Cancer

Armstrong AJ et al. Improved survival with enzalutamide in patients with metastatic hormone-sensitive prostate cancer. J Clin Oncol 2022;40(15):1616-22. Abstract

Chi KN et al. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med 2019;381(1):13-24. Abstract

Fizazi K et al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): A multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design. Lancet 2022;399(10336):1695-707. Abstract

Fizazi K et al.  Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): Final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol 2019;20(5):686-700. Abstract

Hussain H et al. Metastatic hormone-sensitive prostate cancer and combination treatment outcomes: A review. JAMA Oncol 2024;10(6):807-20. Abstract

Saad F et al. Efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase III ARANOTE trial. ESMO 2024;Abstract LBA68.

Smith MR et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med 2022;386(12):1132-42. Abstract

 

Module 3: Current Role of PARP Inhibitors in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Agarwal N et al. Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 TALAPRO-2 trial. Genitourinary Cancers Symposium 2025;Abstract LBA18.

Agarwal N et al. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): A randomised, placebo-controlled, phase 3 trial. Lancet 2023;402(10398):291-303. Abstract

Agarwal N et al. The biology behind combining poly [ADP ribose] polymerase and androgen receptor inhibition for metastatic castration-resistant prostate cancer. Eur J Cancer 2023;192:113249. Abstract

Clarke NW et al. Abiraterone and olaparib for metastatic castration-resistant prostate cancer. NEJM Evid 2022;1(9). Abstract

de Bono J et al. Olaparib for metastatic castration-resistant prostate cancer. N Engl J Med 2020;382(22):2091-102. Abstract

Efstathiou E et al. Niraparib (NIRA) with abiraterone acetate and prednisone (AAP) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations: Second interim analysis (IA2) of MAGNITUDE. Genitourinary Cancers Symposium 2023;Abstract 170.

Pritchard CC et al. Inherited DNA-repair gene mutations in men with metastatic prostate cancer. N Engl J Med 2016;375(5):443-53. Abstract

Robinson D et al. Integrative clinical genomics of advanced prostate cancer. Cell 2015;161(5):1215-28. Abstract

 

Ms Burns

Module 4: Current and Future Role of Radiopharmaceuticals in mCRPC

Calais J et al. Best patient care practices for administering PSMA-targeted radiopharmaceutical therapy. J Nucl Med 2024;65(11):1666-71. 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 prostate cancer.

LEARNING OBJECTIVES

• Infer how various clinical and biological factors affect the risk of prostate cancer recurrence after local therapy, and design appropriate individual treatment plans for patients with consideration of the potential benefits and risks of new and established forms of hormonal therapy.
• Appraise published research findings on optimal management approaches for patients with biochemical recurrence after local treatment for prostate cancer, and offer appropriate counseling about the potential benefits of FDA-approved systemic treatment options.
• Evaluate the published research database supporting the FDA approvals of secondary hormonal agents in the management of nonmetastatic prostate cancer, and apply this information in the discussion of nonresearch treatment options with patients.
• Explore available data with treatment intensification with cytotoxic therapy, secondary hormonal therapy or combinations of these approaches for metastatic hormone-sensitive prostate cancer (mHSPC), and effectively integrate these strategies into clinical management algorithms.
• Appreciate the biological rationale for targeting the PI3K/AKT/mTOR pathway in prostate cancer, and evaluate emerging data with novel AKT inhibitors in combination with hormonal therapy for patients with mHSPC and a PTEN deficiency.
• Establish an evidence-based approach to the selection and sequencing of available therapeutic options for patients with metastatic castration-resistant prostate cancer (mCRPC), considering age, comorbidities, prior therapeutic exposure and other clinical and biological factors.
• Assess the available research database supporting the use of PARP inhibitors as monotherapy or in combination with androgen receptor pathway inhibitors for patients with mCRPC harboring a homologous recombination repair gene alteration, and discern how to optimally incorporate these agents into clinical management algorithms.
• Review available Phase III data documenting the efficacy of various forms of radioligand therapy for patients with mCRPC, and consider the current and potential clinical role of these strategies.
• Recall the design of ongoing clinical trials evaluating other novel agents and strategies for prostate cancer, 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
CME credit is no longer available for this issue.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
CME credit is no longer available for this issue.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
CME credit is no longer available for this issue.

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
CME credit is no longer available for this issue.

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:

Emmanuel S Antonarakis, MD
Clark Endowed Professor of Medicine
Division of Hematology, Oncology and Transplantation
University of Minnesota
Minneapolis, Minnesota

Advisory Committees: Abeona Therapeutics Inc, AstraZeneca Pharmaceuticals LP, Blue Earth Diagnostics, Boundless Bio, Curium, Forbion, Sanofi, Tango Therapeutics; Consulting Agreements: Acerand Therapeutics, Clarity Pharmaceuticals, Curium, EcoR1 Capital LLC, Health Monitor, Lilly, LinKinVax, Vir Biotechnology Inc, Z-Alpha; Contracted Research: Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, MacroGenics Inc, Novartis, Orion Corporation, pharmaand GmbH, Seagen Inc.

Professor Karim Fizazi, MD, PhD
Head of Service and Full Professor
Institut Gustave Roussy
University of Paris Saclay
Villejuif, France

Institutional Honoraria: Advanced Accelerator Applications, Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Janssen Biotech Inc, Merck, MSD, Novartis, Pfizer 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: 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, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, 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 Astellas and Pfizer Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, and Merck.

Release date: May 2025
Expiration date: May 2026

Agarwal N et al. Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 TALAPRO-2 trial. Genitourinary Cancers Symposium 2025;Abstract LBA18.

Agarwal N et al. Cabozantinib (C) plus atezolizumab (A) versus 2nd novel hormonal therapy (NHT) in patients (Pts) with metastatic castration-resistant prostate cancer (mCRPC): Final overall survival (OS) results of the phase III, randomized, CONTACT-02 study. ESMO 2024;Abstract LBA67.

Aggarwal R et al. PRESTO: A phase III, open-label study of intensification of androgen blockade in patients with high-risk biochemically relapsed castration-sensitive prostate cancer (AFT-19). J Clin Oncol 2024;42(10):1114-23. Abstract

André F et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med 2019;380(20):1929-40. Abstract

Azad A et al. Phase III, double-blind, placebo-controlled, 2-cohort, randomized study of saruparib (AZD5305) in combination with androgen receptor pathway inhibitors in patients with metastatic hormone-sensitive prostate cancer with and without homologous recombination repair mutation (EvoPAR-Prostate01). Genitourinary Cancers Symposium 2025;Abstract TPS279.

Azad A et al. Apalutamide (APA) plus intermittent versus continuous androgen-deprivation therapy (ADT) in participants (pts) with metastatic castration-sensitive prostate cancer (mCSPC): LIBERTAS phase 3 study design. Genitourinary Cancers Symposium 2024;Abstract TPS236.

Emmett L et al. Overall survival and quality of life with [(177)Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): Secondary outcomes from a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol 2025;26(3):291-9. Abstract

Fizazi K et al. MK-5684 (ODM-208), a CYP11A1 inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC) with and without AR-LBD mutations: CYPIDES phase 2 results. Genitourinary Cancers Symposium 2024;Abstract 159.

Fizazi K et al. Targeted inhibition of CYP11A1 in castration-resistant prostate cancer. NEJM Evid 2024;3(1). Abstract

Freedland SJ et al. Effects of enzalutamide on the sexual activity of patients with biochemically recurrent prostate cancer: A post hoc analysis of patient-reported outcomes in the EMBARK study. Eur Urol 2025;87(5):507-11. Abstract

Gillessen S et al. A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): First results of EORTC-GUCG 1333/PEACE-3. ESMO 2024;Abstract LBA1.

Gomez-Veiga F et al. Clinical outcomes of enzalutamide in metastatic hormone-sensitive prostate cancer in patients aged <75 and 75 years: ARCHES post hoc analysis. Eur Urol Oncol 2024;7(4):860-9. Abstract

Gratzke CJ et al. Phase 3 OMAHA-004 study of CYP11A1 inhibitor opevesostat versus next-generation hormonal agent (NHA) switch in patients with metastatic castration-resistant prostate cancer (mCRPC) after 1 prior NHA. Genitourinary Cancers Symposium 2025;Abstract TPS301.

Hadaschik BA et al. PRIMORDIUM: A randomized, international, trial-in-progress of adding apalutamide to radiotherapy and an LHRH agonist in high-risk patients with PSMA-PET-positive hormone-sensitive prostate cancer. ESMO 2021;Abstract 649TiP.

Hussain MH et al. Abiraterone, olaparib, or abiraterone + olaparib in first-line metastatic castration-resistant prostate cancer with DNA repair defects (BRCAAway). Clin Cancer Res 2024;30(19):4318-28. Abstract

Morgans AK et al. Darolutamide plus androgen-deprivation therapy (ADT) in patients with high-risk biochemical recurrence (BCR) of prostate cancer: A phase 3, randomized, double-blind, placebo-controlled study (ARASTEP). Genitourinary Cancers Symposium 2025;Abstract TPS432.

Morris MJ et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): A phase 3, randomised, controlled trial. Lancet 2024;404(10459):1227-39. Abstract

Oliveira M et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol 2024;25(11):1424-39. Abstract

Parker CC et al. Randomised trial of no, short-term, or long-term androgen deprivation therapy with postoperative radiotherapy after radical prostatectomy: Results from the three-way comparison of RADICALS-HD (NCT00541047). Eur Urol 2024;86(5):422-30. Abstract

Rathkopf DE et al. AMPLITUDE: A study of niraparib in combination with abiraterone acetate plus prednisone (AAP) versus AAP for the treatment of patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC). Genitourinary Cancers Symposium 2021;Abstract TPS176.

Roubaud G et al. Adjustment for imbalances in baseline characteristics in the MAGNITUDE phase 3 study confirms the clinical benefit of niraparib in combination with abiraterone acetate plus prednisone in patients with metastatic prostate cancer. Eur J Cancer 2024;209:114183. Abstract

Roy S et al. Early prostate-specific antigen response by 6 months is predictive of treatment effect in metastatic hormone sensitive prostate cancer: An exploratory analysis of the TITAN trial. J Urol 2024;212(5):672-81. Abstract

Saad F et al. Efficacy of olaparib (ola) plus abiraterone (abi) versus placebo (pbo) plus abi in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with a germline or somatic BRCA mutation in the PROpel trial. Genitourinary Cancers Symposium 2025;Abstract 219.

Saad F et al. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the phase III ARANOTE trial. J Clin Oncol 2024;42(36):4271-81. Abstract

Saad F et al. Deep and durable prostate-specific antigen response to darolutamide with androgen deprivation therapy and docetaxel, and association with clinical outcomes for patients with high- or low-volume metastatic hormone-sensitive prostate cancer: Analyses of the randomized phase 3 ARASENS study. Eur Urol 2024;86(4):329-39. Abstract

Sartor O et al. Efficacy of 177Lu-PNT2002 in PSMA-positive mCRPC following progression on an androgen-receptor pathway inhibitor (ARPI) (SPLASH). ESMO 2024;Abstract LBA65.

Schweizer MT et al. Mevrometostat (PF-06821497), an enhancer of zeste homolog 2 (EZH2) inhibitor, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC): A randomized dose-expansion study. Genitourinary Cancers Symposium 2025;Abstract LBA138.

Shore N et al. Apalutamide for high-risk localized prostate cancer following radical prostatectomy (Apa-RP). J Urol 2024;212(5):682-91. Abstract

Shore ND et al. Enzalutamide (enza) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post hoc analysis by age. ESMO 2024;Abstract 1638P.

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

Tutrone R et al. Testosterone recovery for relugolix versus leuprolide in men with advanced prostate cancer: Results from the phase 3 HERO study. Eur Urol Oncol 2024;7(4):906-13. Abstract

Yu EY et al. OMAHA-003: A phase 3 study of CYP11A1 inhibitor opevesostat versus next-generation hormonal agent (NHA) switch in metastatic castration-resistant prostate cancer (mCRPC) after NHA and taxane-based chemotherapy. Genitourinary Cancers Symposium 2025;Abstract TPS286.

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 oncologists, hematologists, hematology-oncology fellows, radiation oncologists, surgeons and other allied healthcare professionals involved in the treatment of prostate cancer.

LEARNING OBJECTIVES

• Infer how various clinical and biological factors affect the risk of prostate cancer recurrence after local therapy, and design appropriate individual treatment plans for patients with consideration of the potential benefits and risks of new and established forms of hormonal therapy.
• Appraise published research findings on optimal management approaches for patients with biochemical recurrence after local treatment for prostate cancer, and offer appropriate counseling about the potential benefits of FDA-approved systemic treatment options.
• Evaluate the published research database supporting the FDA approvals of secondary hormonal agents in the management of nonmetastatic prostate cancer, and apply this information in the discussion of nonresearch treatment options with patients.
• Explore available data with treatment intensification with cytotoxic therapy, secondary hormonal therapy or combinations of these approaches for metastatic hormone-sensitive prostate cancer (mHSPC), and effectively integrate these strategies into clinical management algorithms.
• Appreciate the biological rationale for targeting the PI3K/AKT/mTOR pathway in prostate cancer, and evaluate emerging data with novel AKT inhibitors in combination with hormonal therapy for patients with mHSPC and a PTEN deficiency.
• Establish an evidence-based approach to the selection and sequencing of available therapeutic options for patients with metastatic castration-resistant prostate cancer (mCRPC), considering age, comorbidities, prior therapeutic exposure and other clinical and biological factors.
• Assess the available research database supporting the use of PARP inhibitors as monotherapy or in combination with androgen receptor pathway inhibitors for patients with mCRPC harboring a homologous recombination repair gene alteration, and discern how to optimally incorporate these agents into clinical management algorithms.
• Review available Phase III data documenting the efficacy of various forms of radioligand therapy for patients with mCRPC, and consider the current and potential clinical role of these strategies.
• Recall the design of ongoing clinical trials evaluating other novel agents and strategies for prostate cancer, 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
CME credit is no longer available for this issue.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
CME credit is no longer available for this issue.


AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
CME credit is no longer available for this issue.


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
CME credit is no longer available for this issue.

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:

Emmanuel S Antonarakis, MD
Clark Endowed Professor of Medicine
Division of Hematology, Oncology and Transplantation
University of Minnesota
Minneapolis, Minnesota

Advisory Committees: Abeona Therapeutics Inc, AstraZeneca Pharmaceuticals LP, Blue Earth Diagnostics, Boundless Bio, Curium, Forbion, Sanofi, Tango Therapeutics; Consulting Agreements: Acerand Therapeutics, Clarity Pharmaceuticals, Curium, EcoR1 Capital LLC, Health Monitor, Lilly, LinKinVax, Vir Biotechnology Inc, Z-Alpha; Contracted Research: Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, MacroGenics Inc, Novartis, Orion Corporation, pharmaand GmbH, Seagen Inc.

Professor Karim Fizazi, MD, PhD
Head of Service and Full Professor
Institut Gustave Roussy
University of Paris Saclay
Villejuif, France

Institutional Honoraria: Advanced Accelerator Applications, Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Janssen Biotech Inc, Merck, MSD, Novartis, Pfizer 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: 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, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, 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 Astellas and Pfizer Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, and Merck.

Release date: May 2025
Expiration date: May 2026

Agarwal N et al. Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 TALAPRO-2 trial. Genitourinary Cancers Symposium 2025;Abstract LBA18.

Agarwal N et al. Cabozantinib (C) plus atezolizumab (A) versus 2nd novel hormonal therapy (NHT) in patients (Pts) with metastatic castration-resistant prostate cancer (mCRPC): Final overall survival (OS) results of the phase III, randomized, CONTACT-02 study. ESMO 2024;Abstract LBA67.

Aggarwal R et al. PRESTO: A phase III, open-label study of intensification of androgen blockade in patients with high-risk biochemically relapsed castration-sensitive prostate cancer (AFT-19). J Clin Oncol 2024;42(10):1114-23. Abstract

André F et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med 2019;380(20):1929-40. Abstract

Azad A et al. Phase III, double-blind, placebo-controlled, 2-cohort, randomized study of saruparib (AZD5305) in combination with androgen receptor pathway inhibitors in patients with metastatic hormone-sensitive prostate cancer with and without homologous recombination repair mutation (EvoPAR-Prostate01). Genitourinary Cancers Symposium 2025;Abstract TPS279.

Azad A et al. Apalutamide (APA) plus intermittent versus continuous androgen-deprivation therapy (ADT) in participants (pts) with metastatic castration-sensitive prostate cancer (mCSPC): LIBERTAS phase 3 study design. Genitourinary Cancers Symposium 2024;Abstract TPS236.

Emmett L et al. Overall survival and quality of life with [(177)Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): Secondary outcomes from a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol 2025;26(3):291-9. Abstract

Fizazi K et al. MK-5684 (ODM-208), a CYP11A1 inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC) with and without AR-LBD mutations: CYPIDES phase 2 results. Genitourinary Cancers Symposium 2024;Abstract 159.

Fizazi K et al. Targeted inhibition of CYP11A1 in castration-resistant prostate cancer. NEJM Evid 2024;3(1). Abstract

Freedland SJ et al. Effects of enzalutamide on the sexual activity of patients with biochemically recurrent prostate cancer: A post hoc analysis of patient-reported outcomes in the EMBARK study. Eur Urol 2025;87(5):507-11. Abstract

Gillessen S et al. A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): First results of EORTC-GUCG 1333/PEACE-3. ESMO 2024;Abstract LBA1.

Gomez-Veiga F et al. Clinical outcomes of enzalutamide in metastatic hormone-sensitive prostate cancer in patients aged <75 and 75 years: ARCHES post hoc analysis. Eur Urol Oncol 2024;7(4):860-9. Abstract

Gratzke CJ et al. Phase 3 OMAHA-004 study of CYP11A1 inhibitor opevesostat versus next-generation hormonal agent (NHA) switch in patients with metastatic castration-resistant prostate cancer (mCRPC) after 1 prior NHA. Genitourinary Cancers Symposium 2025;Abstract TPS301.

Hadaschik BA et al. PRIMORDIUM: A randomized, international, trial-in-progress of adding apalutamide to radiotherapy and an LHRH agonist in high-risk patients with PSMA-PET-positive hormone-sensitive prostate cancer. ESMO 2021;Abstract 649TiP.

Hussain MH et al. Abiraterone, olaparib, or abiraterone + olaparib in first-line metastatic castration-resistant prostate cancer with DNA repair defects (BRCAAway). Clin Cancer Res 2024;30(19):4318-28. Abstract

Morgans AK et al. Darolutamide plus androgen-deprivation therapy (ADT) in patients with high-risk biochemical recurrence (BCR) of prostate cancer: A phase 3, randomized, double-blind, placebo-controlled study (ARASTEP). Genitourinary Cancers Symposium 2025;Abstract TPS432.

Morris MJ et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): A phase 3, randomised, controlled trial. Lancet 2024;404(10459):1227-39. Abstract

Oliveira M et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol 2024;25(11):1424-39. Abstract

Parker CC et al. Randomised trial of no, short-term, or long-term androgen deprivation therapy with postoperative radiotherapy after radical prostatectomy: Results from the three-way comparison of RADICALS-HD (NCT00541047). Eur Urol 2024;86(5):422-30. Abstract

Rathkopf DE et al. AMPLITUDE: A study of niraparib in combination with abiraterone acetate plus prednisone (AAP) versus AAP for the treatment of patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC). Genitourinary Cancers Symposium 2021;Abstract TPS176.

Roubaud G et al. Adjustment for imbalances in baseline characteristics in the MAGNITUDE phase 3 study confirms the clinical benefit of niraparib in combination with abiraterone acetate plus prednisone in patients with metastatic prostate cancer. Eur J Cancer 2024;209:114183. Abstract

Roy S et al. Early prostate-specific antigen response by 6 months is predictive of treatment effect in metastatic hormone sensitive prostate cancer: An exploratory analysis of the TITAN trial. J Urol 2024;212(5):672-81. Abstract

Saad F et al. Efficacy of olaparib (ola) plus abiraterone (abi) versus placebo (pbo) plus abi in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with a germline or somatic BRCA mutation in the PROpel trial. Genitourinary Cancers Symposium 2025;Abstract 219.

Saad F et al. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the phase III ARANOTE trial. J Clin Oncol 2024;42(36):4271-81. Abstract

Saad F et al. Deep and durable prostate-specific antigen response to darolutamide with androgen deprivation therapy and docetaxel, and association with clinical outcomes for patients with high- or low-volume metastatic hormone-sensitive prostate cancer: Analyses of the randomized phase 3 ARASENS study. Eur Urol 2024;86(4):329-39. Abstract

Sartor O et al. Efficacy of 177Lu-PNT2002 in PSMA-positive mCRPC following progression on an androgen-receptor pathway inhibitor (ARPI) (SPLASH). ESMO 2024;Abstract LBA65.

Schweizer MT et al. Mevrometostat (PF-06821497), an enhancer of zeste homolog 2 (EZH2) inhibitor, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC): A randomized dose-expansion study. Genitourinary Cancers Symposium 2025;Abstract LBA138.

Shore N et al. Apalutamide for high-risk localized prostate cancer following radical prostatectomy (Apa-RP). J Urol 2024;212(5):682-91. Abstract

Shore ND et al. Enzalutamide (enza) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post hoc analysis by age. ESMO 2024;Abstract 1638P.

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

Tutrone R et al. Testosterone recovery for relugolix versus leuprolide in men with advanced prostate cancer: Results from the phase 3 HERO study. Eur Urol Oncol 2024;7(4):906-13. Abstract

Yu EY et al. OMAHA-003: A phase 3 study of CYP11A1 inhibitor opevesostat versus next-generation hormonal agent (NHA) switch in metastatic castration-resistant prostate cancer (mCRPC) after NHA and taxane-based chemotherapy. Genitourinary Cancers Symposium 2025;Abstract TPS286.

Faculty

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

LEARNING OBJECTIVES

• Individualize the selection of systemic therapy for patients with newly diagnosed chronic lymphocytic leukemia (CLL), considering clinical presentation, biomarker profile, coexisting medical conditions and preferences for time-limited or continuous treatment in addition to new research findings.
• Appreciate the scientific rationale for the investigation of combined Bruton tyrosine kinase (BTK) and Bcl-2 inhibition, and review recently presented and emerging 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 demonstrating the efficacy and safety of noncovalent BTK inhibitors for 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 appropriate for treatment with this novel therapeutic strategy.
• Implement a plan of care to recognize and manage side effects and toxicities associated with systemic therapies commonly used in the management of CLL.
• Recall available and emerging data with novel agents and combination strategies currently under investigation for CLL, and appropriately 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
CME credit is no longer available for this issue.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
CME credit is no longer available for this issue.

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
CME credit is no longer available for this issue..

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:

Lindsey Roeker, MD
Senior Associate Consultant
Mayo Clinic
Rochester, Minnesota

Consulting Agreements: AbbVie Inc, Ascentage Pharma, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Janssen Biotech Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Pharmacyclics LLC, an AbbVie Company; CME Speaker: Curio Science, DAVA Oncology; Contracted Research (Research Funding to Institution): AbbVie Inc, Adaptive Biotechnologies Corporation, Aptose Biosciences Inc, AstraZeneca Pharmaceuticals LP, Dren Bio, Genentech, a member of the Roche Group, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Pfizer Inc, Sound Biologics; Data and Safety Monitoring Boards/Committees: Ascentage Pharma; Stock Options/Stock — Public Companies: Abbott Laboratories; Travel Support: Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company; Nonrelevant Financial Relationships: Medscape, PeerView.

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, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, 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 AstreZeneca Pharmaceuticals LP and Lilly.

Release date: May 2025
Expiration date: May 2026

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.

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.

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

Davids MS et al. Primary endpoint evaluation of a multicenter, phase 2 study of acalabrutinib, venetoclax, obinutuzumab (AVO) in a population of previously untreated patients with CLL enriched for high-risk disease. ASH 2024;Abstract 1865.

Jain N et al. Combined pirtobrutinib, venetoclax, and obinutuzumab as first-line treatment of patients with chronic lymphocytic leukemia (CLL). ASH 2024;Abstract 1011.

Levin M-D et al. Improved efficacy with response- and MRD-guided ibrutinib–obinutuzumab (IO) intensification after ibrutinib-venetoclax (IV) in first line chronic lymphocytic leukemia (CLL) patients: Primary Analysis of the HOVON 158/Next STEP phase 2 trial. ASH 2024;Abstract 1013.

Niemann CU et al. First-line ibrutinib plus venetoclax vs chlorambucil plus obinutuzumab in elderly or comorbid patients (pts) with chronic lymphocytic leukemia (CLL): Glow study 64-month follow-up (FU) and adverse event (AE)-free progression-free survival (PFS) analysis. ASH 2024;Abstract 1871.

Roeker L et al. Minimal residual disease (MRD)-adapted duration of front-line venetoclax and obinutuzumab treatment for fit patients with chronic lymphocytic leukemia (CLL). ASH 2024;Abstract 1010.

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.

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.

Simon F et al. Efficacy and safety of acalabrutinib treatment in very old (≥80y) and/or frail patients with chronic lymphocytic leukemia (CLL) – Primary endpoint analysis of the phase II CLL-Frail trial. ASH 2024;Abstract 4618.

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.

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.

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.

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 non-Hodgkin lymphoma.

LEARNING OBJECTIVES

• Evaluate published clinical research establishing the efficacy and safety of Bruton tyrosine kinase (BTK) inhibitors as a component of first-line therapy for mantle cell lymphoma (MCL), and assess the current and potential clinical role of various BTK inhibitor-based strategies for patients newly diagnosed with the disease. 
• Appreciate the biological rationale for, available data with and current clinical role of covalent and noncovalent BTK inhibitors for relapsed/refractory (R/R) MCL, and discern how these agents can be appropriately and safely integrated into routine practice. 
• Identify patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) for whom CD79b-targeted therapy would be appropriate as a component of first-line treatment. 
• Develop an understanding of published clinical research findings with CD19-targeted monoclonal antibodies in combination with immunomodulatory agents in the care of patients with DLBCL and follicular lymphoma (FL), and use this information in patient-education discussions. 
• Appraise the biological rationale for, available research findings with and current clinical role of CD19-targeted antibody-drug conjugates for R/R DLBCL. 
• Assess available clinical trial findings informing the use of CD19-directed chimeric antigen receptor T-cell therapy for R/R DLBCL, FL and MCL, and counsel appropriately selected patients regarding the potential benefits of this strategy. 
• Evaluate the mechanism of action of and available clinical trial findings with CD20 x CD3 bispecific antibodies for FL and DLBCL, and determine the role of these agents in current clinical management. 
• Recall new data with agents and strategies currently under investigation for various subtypes of non-Hodgkin lymphoma, and discuss ongoing clinical trial opportunities with eligible patients. 

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

CREDIT DESIGNATION STATEMENT
CME credit is no longer available for this issue.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
CME credit is no longer available for this issue.

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
CME credit is no longer available for this issue.

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:

Stephen M Ansell, MD, PhD
Chair, Division of Hematology
Dorotha W and Grant L Sundquist Professor in Hematologic Malignancies Research
Enterprise Deputy Director, Mayo Clinic Cancer Center
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota

Advisory Committees: Affimed GmbH; Contracted Research: ADC Therapeutics, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Pfizer Inc, Regeneron Pharmaceuticals Inc, Step Pharma, Takeda Pharmaceuticals USA Inc.

Brian T Hill, MD, PhD
Director, Lymphoid Malignancy Program
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio

Advisory Committees, Consulting Agreements and Contracted Research: AbbVie Inc, ADC Therapeutics, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, Genentech, a member of the Roche Group, Genmab US Inc, Gilead Sciences 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, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, 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 ADC Therapeutics, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, and Novartis.

Release date: May 2025
Expiration date: May 2026

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

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

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

Brooks TR et al. Real-world outcomes with bispecific T-cell engagers (REALBiTE) for relapsed or refractory large B-cell lymphoma: A multi-center, retrospective cohort study. ASH 2024;Abstract 111.

Caimi PF et al. Loncastuximab tesirine in relapsed/refractory diffuse large B-cell lymphoma: Long-term efficacy and safety from the phase II LOTIS-2 study. Haematologica 2024;109(4):1184-93. Abstract

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

Dreyling M et al. High-risk subgroups and MRD: An updated analysis of the phase 3 ECHO trial of acalabrutinib with bendamustine/rituximab in previously untreated mantle cell lymphoma. ASH 2024;Abstract 1626.

Dreyling M et al. Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE): A three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network. Lancet 2024;403(10441):2293-306. Abstract

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

Gaballa S et al. Evaluation of AZD0486, a novel CD19xCD3 T-cell engager, in relapsed/refractory diffuse large B-cell lymphoma in an ongoing first-in-human phase 1 study: High complete responses seen in CAR-T-naive and CAR-T-exposed patients. ASH 2024;Abstract 868.

Hou J-Z et al. Escalating doses of AZD0486, a novel CD19xCD3 T-cell engager, result in high complete remissions with rapid clearance of minimal residual disease in patients with relapsed/refractory follicular lymphoma. ASH 2024;Abstract 341.

Jain P et al. Acalabrutinib with rituximab is highly effective first line treatment for older patients with mantle cell lymphoma. ASH 2024;Abstract 3038.

Kamdar MK et al. Lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) with salvage chemotherapy (CT) followed by autologous stem cell transplantation (ASCT) as second-line (2L) treatment in patients (pt) with R/R large B-cell lymphoma (LBCL): 3-year follow-up (FU) from the randomized, phase 3 TRANSFORM study. ASCO 2024;Abstract 7013.

Kumar A et al. Zanubrutinib, obinutuzumab, and venetoclax for first-line treatment of mantle cell lymphoma with a TP53 mutation. Blood 2025;145(5):497-507. Abstract

Lewis D et al. Ibrutinib-rituximab is superior to rituximab-chemotherapy in previously untreated older mantle cell lymphoma patients: Results from the international randomised controlled trial, Enrich. ASH 2024;Abstract 235.

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

Nastoupil L et al. Lisocabtagene maraleucel (liso-cel) in patients (pts) with relapsed or refractory (R/R) follicular lymphoma (FL): Transcend FL 2-year follow-up. ASH 2024;Abstract 4387.

Neelapu SS et al. 5-year follow-up analysis from ZUMA-5: A phase 2 trial of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory indolent non-hodgkin lymphoma. ASH 2024;Abstract 864.

Phillips TJ et al. Glofitamab in relapsed/refractory mantle cell lymphoma: Results from a phase I/II study. J Clin Oncol 2025;43(3):318-28. Abstract

Riedell PA et al. Rapcabtagene autoleucel (YTB323) in patients (pts) with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL): Phase II trial clinical update. ASH 2024;Abstract 67.

Salles G et al. Five-year analysis of the POLARIX study: Prolonged follow-up confirms positive impact of polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) on outcomes. ASH 2024;Abstract 469.

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

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

Thieblemont C et al. Clinical outcomes of patients with high-risk relapsed/refractory follicular lymphoma treated with tisagenlecleucel: Phase 2 ELARA 4-year update. ASH 2024;Abstract 3034.

Vose JM et al. 3-year update from the Epcore NHL-1 trial: Epcoritamab leads to deep and durable responses in relapsed or refractory large B-cell lymphoma. ASH 2024;Abstract 4480.

Wang M et al. Ibrutinib plus venetoclax in relapsed or refractory mantle cell lymphoma (SYMPATICO): A multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2025;26(2):200-13. Abstract

Wang M et al. Lisocabtagene maraleucel (liso-cel) in patients (pts) with relapsed or refractory (R/R) mantle cell lymphoma (MCL): Results from the final analysis of the MCL cohort of the open-label, phase 1, seamless design, multicenter Transcend NHL 001 (TRANSCEND) study. Transplant Cell Ther 2025;31(Suppl 2):207. Abstract

Wang M et al. Acalabrutinib plus bendamustine and rituximab in untreated mantle cell lymphoma: Results from the phase 3, double-blind, placebo-controlled ECHO trial. EHA 2024;Abstract LB3439.

Wang M et al. Acalabrutinib plus venetoclax and rituximab in treatment-naive mantle cell lymphoma: 2-year safety and efficacy analysis. Blood Adv 2024;8(17):4539-48. Abstract