Year in Review: Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances Involving the PI3K/AKT/mTOR Pathway in HR-Positive Metastatic Breast Cancer

Accreditation types: 1.25 ABIM MOC, ABS MOC, CME

Expires: August 2027

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Faculty

Virginia Kaklamani

Faculty

Virginia Kaklamani

MD, DSc

UT Health San Antonio MD Anderson Cancer Center, San Antonio, Texas

Professor of Medicine, Ruth McLean Bowman Bowers Chair in Breast Cancer Research and Treatment, AB Alexander Distinguished Chair in Oncology, Leader, Breast Oncology Program

Hope S Rugo

Faculty

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

University of California, San Francisco

Professor Emeritus

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

LEARNING OBJECTIVES

  • Review available research documenting the correlation between the presence of various biomarkers (eg, PIK3CA/AKT1/PTEN alterations, ESR1 mutations) and response to specific therapies, and develop optimal testing algorithms for patients with hormone receptor (HR)-positive metastatic breast cancer (mBC).
  • Recognize the frequency of PIK3CA/AKT1/PTEN alterations in patients with HR-positive mBC, and employ evidence-based approaches designed to target these aberrations as appropriate for those with newly diagnosed and relapsed/refractory disease.
  • Understand the biological rationale for the development of agents targeting multiple components of the PI3K/AKT/mTOR pathway, and recognize available data with this strategy for patients with HR-positive, PIK3CA wild-type and PIK3CA-mutant mBC.
  • Evaluate available research findings with and ongoing studies evaluating novel PI3K/AKT/mTOR inhibitor-based approaches, and consider the potential role of these strategies in clinical practice.

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

CREDIT DESIGNATION STATEMENT
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, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and 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, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

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

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, the participant should review the CME information, watch the videos, complete the post-test with a score of 80% or better, and fill out the evaluation.

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:

Dr Kaklamani — Consulting Agreements: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc. Dr Rugo — Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research: Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc; Research Funding (to Institution): ALX Oncology, Bicycle Therapeutics, Genentech, a member of the Roche Group, Mabwell Therapeutics Inc, Merck, Pfizer Inc, Phoenix Molecular Designs, Relay Therapeutics, Stemline Therapeutics Inc.

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

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

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Celcuity.

Release date: August 2026
Expiration date: August 2027

Dr Kaklamani
Basho R et al. INAVO123: Phase 3 study of first-line inavolisib / placebo + a cyclin-dependent kinase 4/6 inhibitor + letrozole in participants with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-sensitive advanced breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract PS5-07-27.

Fernando S et al. PIK3R1 (p85α) alterations define a targetable subset of breast cancer with broad sensitivity to PI3K and AKT inhibitors. San Antonio Breast Cancer Symposium 2025;Abstract RF4-05.

Hilz S et al. Molecular features of response to palbociclib + fulvestrant ± inavolisib in hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer as assessed from baseline circulating tumor DNA in the pivotal phase 3 INAVO120 trial. San Antonio Breast Cancer Symposium 2025;Abstract PD5-09.

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

Kalinsky K et al. Comparative analysis of blood- and tissue-based PIK3CA mutation detection methods in the pivotal phase 3 INAVO120 trial of palbociclib + fulvestrant ± inavolisib in hormone receptor-positive, HER2-negative advanced breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract PS1-10-26.

Loibl S et al. Efficacy of inavolisib (INAVO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2-negative (HER2-), endocrine-resistant advanced breast cancer (aBC) with and without hyperglycaemia (HG) in the phase III INAVO120 trial. ESMO Breast Cancer 2026;Abstract 420RO.

Neven P et al. Capivasertib (C) + ribociclib (R) + fulvestrant (F) in patients (pts) with HR-positive/HER2-negative advanced breast cancer (ABC): CAPItello-292 phase Ib. ESMO Breast Cancer 2025;Abstract 316P.

Sudhan DR et al. Mechanisms of resistance to capivasertib in combination with CDK4/6 inhibitor (CDK4/6i) plus fulvestrant in patients with hormone receptor-positive/HER2-negative (HR+/HER2−) advanced breast cancer (ABC): Exploratory analysis from the phase 1b CAPItello-292 study. San Antonio Breast Cancer Symposium 2025;Abstract RF4-04.

Wesolowski R et al. Gedatolisib combined with palbociclib and letrozole in patients with no prior systemic therapy for hormone receptor-positive, HER2-negative advanced breast cancer. Clin Cancer Res 2025;31(19):4040-8. Abstract

Dr Rugo
Hurvitz SA et al. A randomized, open-label, phase 3 study of gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2−/PIK3CA-mutant (MT) advanced breast cancer (VIKTORIA-1 Study 2). ASCO 2026;Abstract LBA1008.

Jhaveri KL et al. A phase 1/2 trial of tersolisib (LY4064809/STX-478), a pan-mutant-selective PI3Kα inhibitor (PI3Kαi), in PIK3CA-mutant advanced solid tumors: Updated results from PIKALO-1. ASCO 2026;Abstract 1072.

Pistilli B et al. Gedatolisib (Geda), a multitarget PI3K/AKT/mTOR (PAM) inhibitor, plus fulvestrant (Fulv) ± palbociclib (Palbo) for second-line (2L) treatment of patients (Pts) with HR+/HER2-/PIK3CA-wild type (WT) advanced breast cancer (ABC): Updated results from VIKTORIA-1. ESMO Breast Cancer 2026;Abstract 505P.

Rugo HS et al. Capivasertib (C) and fulvestrant (F) for patients (pts) with HR+/HER2- advanced breast cancer (ABC): Final overall survival (OS) results from the phase III CAPItello-291 trial. ESMO Breast Cancer 2026;Abstract 417O.

Rugo HS et al. Capivasertib plus fulvestrant as first and second-line endocrine-based therapy in PIK3CA/AKT1/PTEN-altered hormone receptor-positive advanced breast cancer: Subgroup analysis from the phase 3 CAPItello-291 trial. ESMO 2025;Abstract 526P.

Saura C et al. Efficacy of mutant-selective PI3Kα inhibitor RLY-2608 in combination with fulvestrant in patient (pt) subset populations, including pts with PIK3CA-mutant HR+/HER2- advanced breast cancer (BC) pre-treated with fulvestrant or other SERD. San Antonio Breast Cancer Symposium 2025;Abstract PD10-07.

Turner NC et al. Capivasertib plus fulvestrant in hormone receptor-positive (HR+) advanced breast cancer (ABC): Exploratory ctDNA analyses from the phase 3 CAPItello-291 trial. San Antonio Breast Cancer Symposium 2025;Abstract RF7-05.

Vaklavas C et al. Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: Results from SERENA-1. ESMO Open 2026;11(2):106049. Abstract

Year in Review: Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances Involving the PI3K/AKT/mTOR Pathway in HR-Positive Metastatic Breast Cancer

Accreditation types: 1.25 ABIM MOC, ABS MOC, CME

Expires: August 2027

To play this presentation please log in.


Don't have an account?

Sign up for free and get access to 400+ programs, live events, CME/CNE evaluations, bookmarks, watch history, and more.

Faculty

Virginia Kaklamani

Faculty

Virginia Kaklamani

MD, DSc

UT Health San Antonio MD Anderson Cancer Center, San Antonio, Texas

Professor of Medicine, Ruth McLean Bowman Bowers Chair in Breast Cancer Research and Treatment, AB Alexander Distinguished Chair in Oncology, Leader, Breast Oncology Program

Hope S Rugo

Faculty

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

University of California, San Francisco

Professor Emeritus

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

LEARNING OBJECTIVES

  • Review available research documenting the correlation between the presence of various biomarkers (eg, PIK3CA/AKT1/PTEN alterations, ESR1 mutations) and response to specific therapies, and develop optimal testing algorithms for patients with hormone receptor (HR)-positive metastatic breast cancer (mBC).
  • Recognize the frequency of PIK3CA/AKT1/PTEN alterations in patients with HR-positive mBC, and employ evidence-based approaches designed to target these aberrations as appropriate for those with newly diagnosed and relapsed/refractory disease.
  • Understand the biological rationale for the development of agents targeting multiple components of the PI3K/AKT/mTOR pathway, and recognize available data with this strategy for patients with HR-positive, PIK3CA wild-type and PIK3CA-mutant mBC.
  • Evaluate available research findings with and ongoing studies evaluating novel PI3K/AKT/mTOR inhibitor-based approaches, and consider the potential role of these strategies in clinical practice.

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

CREDIT DESIGNATION STATEMENT
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, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and 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, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

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

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, the participant should review the CME information, watch the videos, complete the post-test with a score of 80% or better, and fill out the evaluation.

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:

Dr Kaklamani — Consulting Agreements: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc. Dr Rugo — Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research: Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc; Research Funding (to Institution): ALX Oncology, Bicycle Therapeutics, Genentech, a member of the Roche Group, Mabwell Therapeutics Inc, Merck, Pfizer Inc, Phoenix Molecular Designs, Relay Therapeutics, Stemline Therapeutics Inc.

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

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

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Celcuity.

Release date: August 2026
Expiration date: August 2027

Dr Kaklamani
Basho R et al. INAVO123: Phase 3 study of first-line inavolisib / placebo + a cyclin-dependent kinase 4/6 inhibitor + letrozole in participants with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-sensitive advanced breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract PS5-07-27.

Fernando S et al. PIK3R1 (p85α) alterations define a targetable subset of breast cancer with broad sensitivity to PI3K and AKT inhibitors. San Antonio Breast Cancer Symposium 2025;Abstract RF4-05.

Hilz S et al. Molecular features of response to palbociclib + fulvestrant ± inavolisib in hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer as assessed from baseline circulating tumor DNA in the pivotal phase 3 INAVO120 trial. San Antonio Breast Cancer Symposium 2025;Abstract PD5-09.

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

Kalinsky K et al. Comparative analysis of blood- and tissue-based PIK3CA mutation detection methods in the pivotal phase 3 INAVO120 trial of palbociclib + fulvestrant ± inavolisib in hormone receptor-positive, HER2-negative advanced breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract PS1-10-26.

Loibl S et al. Efficacy of inavolisib (INAVO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2-negative (HER2-), endocrine-resistant advanced breast cancer (aBC) with and without hyperglycaemia (HG) in the phase III INAVO120 trial. ESMO Breast Cancer 2026;Abstract 420RO.

Neven P et al. Capivasertib (C) + ribociclib (R) + fulvestrant (F) in patients (pts) with HR-positive/HER2-negative advanced breast cancer (ABC): CAPItello-292 phase Ib. ESMO Breast Cancer 2025;Abstract 316P.

Sudhan DR et al. Mechanisms of resistance to capivasertib in combination with CDK4/6 inhibitor (CDK4/6i) plus fulvestrant in patients with hormone receptor-positive/HER2-negative (HR+/HER2−) advanced breast cancer (ABC): Exploratory analysis from the phase 1b CAPItello-292 study. San Antonio Breast Cancer Symposium 2025;Abstract RF4-04.

Wesolowski R et al. Gedatolisib combined with palbociclib and letrozole in patients with no prior systemic therapy for hormone receptor-positive, HER2-negative advanced breast cancer. Clin Cancer Res 2025;31(19):4040-8. Abstract

Dr Rugo
Hurvitz SA et al. A randomized, open-label, phase 3 study of gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2−/PIK3CA-mutant (MT) advanced breast cancer (VIKTORIA-1 Study 2). ASCO 2026;Abstract LBA1008.

Jhaveri KL et al. A phase 1/2 trial of tersolisib (LY4064809/STX-478), a pan-mutant-selective PI3Kα inhibitor (PI3Kαi), in PIK3CA-mutant advanced solid tumors: Updated results from PIKALO-1. ASCO 2026;Abstract 1072.

Pistilli B et al. Gedatolisib (Geda), a multitarget PI3K/AKT/mTOR (PAM) inhibitor, plus fulvestrant (Fulv) ± palbociclib (Palbo) for second-line (2L) treatment of patients (Pts) with HR+/HER2-/PIK3CA-wild type (WT) advanced breast cancer (ABC): Updated results from VIKTORIA-1. ESMO Breast Cancer 2026;Abstract 505P.

Rugo HS et al. Capivasertib (C) and fulvestrant (F) for patients (pts) with HR+/HER2- advanced breast cancer (ABC): Final overall survival (OS) results from the phase III CAPItello-291 trial. ESMO Breast Cancer 2026;Abstract 417O.

Rugo HS et al. Capivasertib plus fulvestrant as first and second-line endocrine-based therapy in PIK3CA/AKT1/PTEN-altered hormone receptor-positive advanced breast cancer: Subgroup analysis from the phase 3 CAPItello-291 trial. ESMO 2025;Abstract 526P.

Saura C et al. Efficacy of mutant-selective PI3Kα inhibitor RLY-2608 in combination with fulvestrant in patient (pt) subset populations, including pts with PIK3CA-mutant HR+/HER2- advanced breast cancer (BC) pre-treated with fulvestrant or other SERD. San Antonio Breast Cancer Symposium 2025;Abstract PD10-07.

Turner NC et al. Capivasertib plus fulvestrant in hormone receptor-positive (HR+) advanced breast cancer (ABC): Exploratory ctDNA analyses from the phase 3 CAPItello-291 trial. San Antonio Breast Cancer Symposium 2025;Abstract RF7-05.

Vaklavas C et al. Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: Results from SERENA-1. ESMO Open 2026;11(2):106049. Abstract

Year in Review: Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances in Gastroesophageal Cancers

Accreditation types: 1.25 ABIM MOC, ABS MOC, CME

Expires: August 2027

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Faculty

David H Ilson

Faculty

David H Ilson

MD, PhD

Memorial Sloan Kettering Cancer Center, New York, New York

Attending Physician, Member

Weill Cornell Medical College, New York, New York

Professor of Medicine

Kohei Shitara

Faculty

Kohei Shitara

MD

National Cancer Center Hospital East, Kashiwa, Japan

Chief of the Department of Gastrointestinal Oncology

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

LEARNING OBJECTIVES

  • Evaluate recently presented clinical research findings to determine their effect on the current management of gastric, gastroesophageal junction (GEJ) and esophageal cancers.
  • Recognize available clinical research findings with immune checkpoint inhibitors as neoadjuvant, adjuvant or perioperative therapy for patients with resectable gastric, GEJ and esophageal cancers, and consider the current role of these approaches.
  • Describe published research data with anti-PD-1/PD-L1 antibodies alone or in combination with other systemic therapies in the management of metastatic gastric, GEJ and esophageal cancers, and optimally integrate these strategies into treatment algorithms.
  • Assess available data with monoclonal antibody therapy directed at claudin 18.2 (CLDN18.2) in combination with chemotherapy as first-line treatment for patients with HER2-negative, CLDN18.2-positive gastric or GEJ cancer, and optimally incorporate this approach into management algorithms.
  • Review published research findings with established HER2-targeted therapies for patients with HER2-positive gastroesophageal cancers, and assess the current role of various agents and regimens.
  • Review the rationale for, available data with and ongoing research studies evaluating novel agents and strategies for patients with gastroesophageal cancers in preparation for potential clinical availability or to enhance trial participation.

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

CREDIT DESIGNATION STATEMENT
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, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and 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, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

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

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, 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.

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 — Dr Shitara has no relevant financial relationships to disclose. The following faculty reported relevant financial relationships with ineligible entities:

Dr Ilson — Advisory Committees: Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Daiichi Sankyo Inc, Lilly, Merck, Oncolys BioPharma, Roche Laboratories Inc, Taiho Oncology Inc; Consulting Agreements: Astellas.

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

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

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, BeOne, and Daiichi Sankyo Inc.

Release date: August 2026
Expiration date: August 2027

Dr Ilson
Cruz-Correa M et al. Tislelizumab + chemotherapy in gastric cancer: Long-term RATIONALE-305 randomized trial follow-up. Adv Ther 2026;43(1):165-83. Abstract

Janjigian YY et al. Nivolumab plus chemotherapy as first-line treatment for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: 5-year follow-up results from CheckMate 649. Ann Oncol 2026;37(6):787-97. Abstract

Kawazoe A et al. KEYNOTE-811: 6-year median follow-up of pembrolizumab plus trastuzumab and chemotherapy for previously untreated advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma. ASCO 2026;Abstract 4040.

Leone AG et al. STRIDE regimen of tremelimumab and durvalumab as non-operative management strategy of microsatellite instability-high (MSI-H) resectable gastric or gastroesophageal junction adenocarcinoma (GAC/GEJAC): Final results of the cohort 2 of INFINITY study by GONO GI. AACR 2026;Abstract CT230.

Metges JP et al. Pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer: 5-year extended follow-up for the randomized phase III KEYNOTE-590 study. ESMO Open 2025;10(12):105854. Abstract

Oh DY et al. Nivolumab plus ipilimumab combined with chemotherapy as first-line treatment for HER2-negative unresectable advanced or recurrent gastric/gastroesophageal junction cancer: A randomized phase 3 trial (ATTRACTION-6). ASCO 2026;Abstract 4006.

Samaille T et al. Neoadjuvant nivolumab plus ipilimumab and adjuvant nivolumab in patients with localized microsatellite instability-high (MSI)/mismatch repair deficient (dMMR) oeso-gastric adenocarcinoma: Long-term follow-up of the GERCOR NEONIPIGA phase II study. ASCO 2026;Abstract 4099.

Stein A et al. Perioperative pembrolizumab, trastuzumab and FLOT in HER2-positive localized esophagogastric adenocarcinoma: A phase 2 trial. Nat Med 2025;31(12):4197-204. Abstract

Tabernero J et al. Final overall survival (OS) and the association of pathological outcomes with event-free survival (EFS) in MATTERHORN: A randomised, phase III study of durvalumab (D) plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric/gastroesophageal (G/GEJ) adenocarcinoma. ESMO 2025;Abstract LBA81.

Wainberg ZA et al. Efficacy of durvalumab and safety by treatment period in MATTERHORN: A randomized, phase 3 study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. ASCO 2026;Abstract 4070.

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

Janjigian YY et al. First-line (1L) trastuzumab deruxtecan (T-DXd)–based regimens in advanced HER2-expressing gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJA), or esophageal adenocarcinoma (EA): Safety results from DESTINY-Gastric03 (DG-03) Part 2 arms D and F, and Part 4. ASCO 2026;Abstract 4022.

Lu Z et al. Izalontamab brengitecan (iza-bren) versus chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC): A multicenter, randomized, open-label, phase III study. ASCO 2026;Abstract 4008.

Rha SY et al. Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (mGEA): PD-L1 subgroup analysis from HERIZON-GEA-01. ASCO 2026;Abstract 4010.

Shah M et al. ARTEMIDE-Gastric01: A phase 3 randomized study of rilvegostomig with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) as first-line (1L) treatment for locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer (GC/GEJC). Gastrointestinal Cancers Symposium 2026;Abstract TPS460.

Shitara K et al. CLARITY-Gastric01: A randomized phase 3 study of sonesitatug vedotin (sone ve), a claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate, in second- or later-line (2L+) advanced gastric or gastroesophageal junction cancer (GJ/GEJC). Gastrointestinal Cancers Symposium 2026;Abstract TPS462.

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

Shitara K et al. Sonesitatug vedotin (Sone-Ve) monotherapy in patients (pts) with claudin 18.2-positive (CLDN18.2+) advanced or metastatic gastric or gastroesophageal junction (GEJ) cancers: Data from CLARITY-PanTumor01. ASCO 2026;Abstract 4023.

Shitara K et al. Zolbetuximab + pembrolizumab and chemotherapy as first-line treatment for patients with CLDN18.2-positive, HER2-negative, PD-L1-positive locally advanced unresectable or metastatic G/GEJ adenocarcinoma: Phase 3, double-blind, randomized trial (LUCERNA). Gastrointestinal Cancers Symposium 2026;Abstract TPS473.

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

Year in Review: Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances in Gastroesophageal Cancers

Accreditation types: 1 ABIM MOC, ABS MOC, CME

Expires: August 2027

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Faculty

David H Ilson

Faculty

David H Ilson

MD, PhD

Memorial Sloan Kettering Cancer Center, New York, New York

Attending Physician, Member

Weill Cornell Medical College, New York, New York

Professor of Medicine

Kohei Shitara

Faculty

Kohei Shitara

MD

National Cancer Center Hospital East, Kashiwa, Japan

Chief of the Department of Gastrointestinal Oncology

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

LEARNING OBJECTIVES

  • Evaluate recently presented clinical research findings to determine their effect on the current management of gastric, gastroesophageal junction (GEJ) and esophageal cancers.
  • Recognize available clinical research findings with immune checkpoint inhibitors as neoadjuvant, adjuvant or perioperative therapy for patients with resectable gastric, GEJ and esophageal cancers, and consider the current role of these approaches.
  • Describe published research data with anti-PD-1/PD-L1 antibodies alone or in combination with other systemic therapies in the management of metastatic gastric, GEJ and esophageal cancers, and optimally integrate these strategies into treatment algorithms.
  • Assess available data with monoclonal antibody therapy directed at claudin 18.2 (CLDN18.2) in combination with chemotherapy as first-line treatment for patients with HER2-negative, CLDN18.2-positive gastric or GEJ cancer, and optimally incorporate this approach into management algorithms.
  • Review published research findings with established HER2-targeted therapies for patients with HER2-positive gastroesophageal cancers, and assess the current role of various agents and regimens.
  • Review the rationale for, available data with and ongoing research studies evaluating novel agents and strategies for patients with gastroesophageal cancers in preparation for potential clinical availability or to enhance trial participation.

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

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit™. 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 Medical Knowledge MOC point 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, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and 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, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

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

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, 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.

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 — Dr Shitara has no relevant financial relationships to disclose. The following faculty reported relevant financial relationships with ineligible entities:

Dr Ilson — Advisory Committees: Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Daiichi Sankyo Inc, Lilly, Merck, Oncolys BioPharma, Roche Laboratories Inc, Taiho Oncology Inc; Consulting Agreements: Astellas.

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

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

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, BeOne, and Daiichi Sankyo Inc.

Release date: August 2026
Expiration date: August 2027

Dr Ilson
Cruz-Correa M et al. Tislelizumab + chemotherapy in gastric cancer: Long-term RATIONALE-305 randomized trial follow-up. Adv Ther 2026;43(1):165-83. Abstract

Janjigian YY et al. Nivolumab plus chemotherapy as first-line treatment for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: 5-year follow-up results from CheckMate 649. Ann Oncol 2026;37(6):787-97. Abstract

Kawazoe A et al. KEYNOTE-811: 6-year median follow-up of pembrolizumab plus trastuzumab and chemotherapy for previously untreated advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma. ASCO 2026;Abstract 4040.

Leone AG et al. STRIDE regimen of tremelimumab and durvalumab as non-operative management strategy of microsatellite instability-high (MSI-H) resectable gastric or gastroesophageal junction adenocarcinoma (GAC/GEJAC): Final results of the cohort 2 of INFINITY study by GONO GI. AACR 2026;Abstract CT230.

Metges JP et al. Pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer: 5-year extended follow-up for the randomized phase III KEYNOTE-590 study. ESMO Open 2025;10(12):105854. Abstract

Oh DY et al. Nivolumab plus ipilimumab combined with chemotherapy as first-line treatment for HER2-negative unresectable advanced or recurrent gastric/gastroesophageal junction cancer: A randomized phase 3 trial (ATTRACTION-6). ASCO 2026;Abstract 4006.

Samaille T et al. Neoadjuvant nivolumab plus ipilimumab and adjuvant nivolumab in patients with localized microsatellite instability-high (MSI)/mismatch repair deficient (dMMR) oeso-gastric adenocarcinoma: Long-term follow-up of the GERCOR NEONIPIGA phase II study. ASCO 2026;Abstract 4099.

Stein A et al. Perioperative pembrolizumab, trastuzumab and FLOT in HER2-positive localized esophagogastric adenocarcinoma: A phase 2 trial. Nat Med 2025;31(12):4197-204. Abstract

Tabernero J et al. Final overall survival (OS) and the association of pathological outcomes with event-free survival (EFS) in MATTERHORN: A randomised, phase III study of durvalumab (D) plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric/gastroesophageal (G/GEJ) adenocarcinoma. ESMO 2025;Abstract LBA81.

Wainberg ZA et al. Efficacy of durvalumab and safety by treatment period in MATTERHORN: A randomized, phase 3 study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. ASCO 2026;Abstract 4070.

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

Janjigian YY et al. First-line (1L) trastuzumab deruxtecan (T-DXd)–based regimens in advanced HER2-expressing gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJA), or esophageal adenocarcinoma (EA): Safety results from DESTINY-Gastric03 (DG-03) Part 2 arms D and F, and Part 4. ASCO 2026;Abstract 4022.

Lu Z et al. Izalontamab brengitecan (iza-bren) versus chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC): A multicenter, randomized, open-label, phase III study. ASCO 2026;Abstract 4008.

Rha SY et al. Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (mGEA): PD-L1 subgroup analysis from HERIZON-GEA-01. ASCO 2026;Abstract 4010.

Shah M et al. ARTEMIDE-Gastric01: A phase 3 randomized study of rilvegostomig with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) as first-line (1L) treatment for locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer (GC/GEJC). Gastrointestinal Cancers Symposium 2026;Abstract TPS460.

Shitara K et al. CLARITY-Gastric01: A randomized phase 3 study of sonesitatug vedotin (sone ve), a claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate, in second- or later-line (2L+) advanced gastric or gastroesophageal junction cancer (GJ/GEJC). Gastrointestinal Cancers Symposium 2026;Abstract TPS462.

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

Shitara K et al. Sonesitatug vedotin (Sone-Ve) monotherapy in patients (pts) with claudin 18.2-positive (CLDN18.2+) advanced or metastatic gastric or gastroesophageal junction (GEJ) cancers: Data from CLARITY-PanTumor01. ASCO 2026;Abstract 4023.

Shitara K et al. Zolbetuximab + pembrolizumab and chemotherapy as first-line treatment for patients with CLDN18.2-positive, HER2-negative, PD-L1-positive locally advanced unresectable or metastatic G/GEJ adenocarcinoma: Phase 3, double-blind, randomized trial (LUCERNA). Gastrointestinal Cancers Symposium 2026;Abstract TPS473.

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

Year in Review: Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances in Gastroesophageal Cancers

Accreditation types: 1 ABIM MOC, ABS MOC, CME

Expires: August 2027

To play this presentation please log in.


Don't have an account?

Sign up for free and get access to 400+ programs, live events, CME/CNE evaluations, bookmarks, watch history, and more.

Faculty

David H Ilson

Faculty

David H Ilson

MD, PhD

Memorial Sloan Kettering Cancer Center, New York, New York

Attending Physician, Member

Weill Cornell Medical College, New York, New York

Professor of Medicine

Kohei Shitara

Faculty

Kohei Shitara

MD

National Cancer Center Hospital East, Kashiwa, Japan

Chief of the Department of Gastrointestinal Oncology

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

LEARNING OBJECTIVES

  • Evaluate recently presented clinical research findings to determine their effect on the current management of gastric, gastroesophageal junction (GEJ) and esophageal cancers.
  • Recognize available clinical research findings with immune checkpoint inhibitors as neoadjuvant, adjuvant or perioperative therapy for patients with resectable gastric, GEJ and esophageal cancers, and consider the current role of these approaches.
  • Describe published research data with anti-PD-1/PD-L1 antibodies alone or in combination with other systemic therapies in the management of metastatic gastric, GEJ and esophageal cancers, and optimally integrate these strategies into treatment algorithms.
  • Assess available data with monoclonal antibody therapy directed at claudin 18.2 (CLDN18.2) in combination with chemotherapy as first-line treatment for patients with HER2-negative, CLDN18.2-positive gastric or GEJ cancer, and optimally incorporate this approach into management algorithms.
  • Review published research findings with established HER2-targeted therapies for patients with HER2-positive gastroesophageal cancers, and assess the current role of various agents and regimens.
  • Review the rationale for, available data with and ongoing research studies evaluating novel agents and strategies for patients with gastroesophageal cancers in preparation for potential clinical availability or to enhance trial participation.

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

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit™. 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 Medical Knowledge MOC point 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, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and 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, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

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

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, 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.

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 — Dr Shitara has no relevant financial relationships to disclose. The following faculty reported relevant financial relationships with ineligible entities:

Dr Ilson — Advisory Committees: Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Daiichi Sankyo Inc, Lilly, Merck, Oncolys BioPharma, Roche Laboratories Inc, Taiho Oncology Inc; Consulting Agreements: Astellas.

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

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

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, BeOne, and Daiichi Sankyo Inc.

Release date: August 2026
Expiration date: August 2027

Dr Ilson
Cruz-Correa M et al. Tislelizumab + chemotherapy in gastric cancer: Long-term RATIONALE-305 randomized trial follow-up. Adv Ther 2026;43(1):165-83. Abstract

Janjigian YY et al. Nivolumab plus chemotherapy as first-line treatment for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: 5-year follow-up results from CheckMate 649. Ann Oncol 2026;37(6):787-97. Abstract

Kawazoe A et al. KEYNOTE-811: 6-year median follow-up of pembrolizumab plus trastuzumab and chemotherapy for previously untreated advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma. ASCO 2026;Abstract 4040.

Leone AG et al. STRIDE regimen of tremelimumab and durvalumab as non-operative management strategy of microsatellite instability-high (MSI-H) resectable gastric or gastroesophageal junction adenocarcinoma (GAC/GEJAC): Final results of the cohort 2 of INFINITY study by GONO GI. AACR 2026;Abstract CT230.

Metges JP et al. Pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer: 5-year extended follow-up for the randomized phase III KEYNOTE-590 study. ESMO Open 2025;10(12):105854. Abstract

Oh DY et al. Nivolumab plus ipilimumab combined with chemotherapy as first-line treatment for HER2-negative unresectable advanced or recurrent gastric/gastroesophageal junction cancer: A randomized phase 3 trial (ATTRACTION-6). ASCO 2026;Abstract 4006.

Samaille T et al. Neoadjuvant nivolumab plus ipilimumab and adjuvant nivolumab in patients with localized microsatellite instability-high (MSI)/mismatch repair deficient (dMMR) oeso-gastric adenocarcinoma: Long-term follow-up of the GERCOR NEONIPIGA phase II study. ASCO 2026;Abstract 4099.

Stein A et al. Perioperative pembrolizumab, trastuzumab and FLOT in HER2-positive localized esophagogastric adenocarcinoma: A phase 2 trial. Nat Med 2025;31(12):4197-204. Abstract

Tabernero J et al. Final overall survival (OS) and the association of pathological outcomes with event-free survival (EFS) in MATTERHORN: A randomised, phase III study of durvalumab (D) plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric/gastroesophageal (G/GEJ) adenocarcinoma. ESMO 2025;Abstract LBA81.

Wainberg ZA et al. Efficacy of durvalumab and safety by treatment period in MATTERHORN: A randomized, phase 3 study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. ASCO 2026;Abstract 4070.

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

Janjigian YY et al. First-line (1L) trastuzumab deruxtecan (T-DXd)–based regimens in advanced HER2-expressing gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJA), or esophageal adenocarcinoma (EA): Safety results from DESTINY-Gastric03 (DG-03) Part 2 arms D and F, and Part 4. ASCO 2026;Abstract 4022.

Lu Z et al. Izalontamab brengitecan (iza-bren) versus chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC): A multicenter, randomized, open-label, phase III study. ASCO 2026;Abstract 4008.

Rha SY et al. Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (mGEA): PD-L1 subgroup analysis from HERIZON-GEA-01. ASCO 2026;Abstract 4010.

Shah M et al. ARTEMIDE-Gastric01: A phase 3 randomized study of rilvegostomig with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) as first-line (1L) treatment for locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer (GC/GEJC). Gastrointestinal Cancers Symposium 2026;Abstract TPS460.

Shitara K et al. CLARITY-Gastric01: A randomized phase 3 study of sonesitatug vedotin (sone ve), a claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate, in second- or later-line (2L+) advanced gastric or gastroesophageal junction cancer (GJ/GEJC). Gastrointestinal Cancers Symposium 2026;Abstract TPS462.

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

Shitara K et al. Sonesitatug vedotin (Sone-Ve) monotherapy in patients (pts) with claudin 18.2-positive (CLDN18.2+) advanced or metastatic gastric or gastroesophageal junction (GEJ) cancers: Data from CLARITY-PanTumor01. ASCO 2026;Abstract 4023.

Shitara K et al. Zolbetuximab + pembrolizumab and chemotherapy as first-line treatment for patients with CLDN18.2-positive, HER2-negative, PD-L1-positive locally advanced unresectable or metastatic G/GEJ adenocarcinoma: Phase 3, double-blind, randomized trial (LUCERNA). Gastrointestinal Cancers Symposium 2026;Abstract TPS473.

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

The Implications of Recent Datasets for the Current and Future Management of Genitourinary Cancers — An ASCO 2026 Review

Accreditation types: 1.75 ABIM MOC, ABS MOC, CME

Expires: August 2027

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FDA Update: Subsequent to the recording of this program, on 09/24/2026, the FDA approved belzutifan in combination with lenvatinib for adults with advanced renal cell carcinoma with a clear cell component after a programmed death receptor-1 or programmed death-ligand 1 inhibitor.

Faculty

Rahul Aggarwal

Faculty

Rahul Aggarwal

MD

University of California, San Francisco, San Francisco, California

Professor of Medicine and Thomas Perkins Distinguished Professor of Cancer Research, Program Leader, Genitourinary Medical Oncology, Division of Hematology/Oncology

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California

Associate Director for Clinical Research

Matthew D Galsky

Faculty

Matthew D Galsky

MD

Icahn School of Medicine at Mount Sinai, New York, New York

Lillian and Howard Stratton Professor of Medicine

Mount Sinai Tisch Cancer Center, New York, New York

Deputy Director

Tian Zhang

Faculty

Tian Zhang

MD, MHS, FASCO

UT Southwestern Medical Center, Dallas, Texas

Associate Professor, Director of Clinical Research, Division of Hematology and Oncology, Department of Internal Medicine

Simmons Comprehensive Cancer Center, Dallas, Texas

Associate Director for Clinical Research

TARGET AUDIENCE
This activity is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of genitourinary cancers.

LEARNING OBJECTIVES

  • Evaluate recently presented clinical research findings to determine their effect on the current management of localized or metastatic prostate cancer.
  • Explore available data with treatment intensification for hormone-sensitive localized or metastatic prostate cancer, and effectively integrate FDA-approved strategies into current clinical management algorithms.
  • Assess the available research database supporting PARP inhibitors in combination with androgen receptor pathway inhibitors for patients with metastatic prostate cancer harboring a homologous recombination repair gene alteration, and discern how to optimally incorporate these agents into current clinical management algorithms.
  • Appreciate the biological rationale for targeting the PI3K/AKT/mTOR pathway for prostate cancer, and evaluate available data with novel AKT inhibitors in combination with hormonal therapy for patients with PTEN deficiency.
  • Review available Phase III data documenting the efficacy of various forms of radioligand therapy for metastatic prostate cancer, and consider the current and potential future clinical role of these strategies.
  • Optimize the management of non-muscle-invasive bladder cancer (NMIBC), considering the efficacy and tolerability of FDA-endorsed and other emerging novel therapeutic strategies.
  • Appraise clinical research findings with perioperative anti-PD-1/PD-L1 antibody therapy alone and in combination with antibody-drug conjugate therapy for muscle-invasive bladder cancer (MIBC).
  • Develop an understanding of the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker for MIBC, and evaluate available research data documenting the benefit of adjuvant anti-PD-1/PD-L1 antibody therapy for patients who are ctDNA positive following cystectomy.
  • Appreciate how various clinical and biological factors, including prior therapeutic exposure, affect the selection and sequencing of therapy for patients with metastatic urothelial bladder cancer (UBC).
  • Develop a rational approach to the sequencing of systemic therapies for patients with advanced renal cell carcinoma (RCC), incorporating immunotherapeutic agents, multikinase inhibitors, HIF-2α inhibitors or combinations of these approaches.
  • Appreciate published clinical research findings evaluating available and investigational agents for non-clear cell RCC, and consider the applicability of these strategies in current clinical care.
  • Recall available and emerging data with other novel and investigational agents and strategies currently in testing for prostate cancer, UBC and RCC, and refer eligible patients for clinical trial participation.

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

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.75 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for 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, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and 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, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

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

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, 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.

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 — Dr Brody has no relevant financial relationships to disclose. The following faculty reported relevant financial relationships with ineligible entities:

Dr Aggarwal — Advisory Committees: AbbVie Inc, Amgen Inc, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Merck, Pfizer Inc; Consulting Agreements: Boxer Capital Management, EcoR1 Capital, Genentech, a member of the Roche Group; Contracted Research: Amgen Inc, AstraZeneca Pharmaceuticals LP, Johnson & Johnson, Merck, Novartis, Zenith Epigenetics; Nonrelevant Financial Relationships: Prostate Cancer Clinical Trials Consortium. Dr Galsky — Contracted Research: Astellas, Merck, Seagen Inc; Travel Support: Pfizer Inc. Dr Zhang — Advisory Committees: Amgen Inc, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Dendreon Pharmaceuticals Inc, Eisai Inc, EMD Serono Inc, Exelixis Inc, Gilead Sciences Inc, Janssen Biotech Inc, Lilly, Merck, Novartis, Pfizer Inc, Sanofi, Summit Therapeutics, Xencor; Consulting Agreements: Aptitude Health, DAVA Oncology, eChinaHealth, Pfizer Inc, Vaniam Group; Contracted Research: ALX Oncology, Arcus Biosciences, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Exelixis Inc, Janssen Biotech Inc, Janux Therapeutics, Kura Oncology, Lilly, Merck, OncoC4, Pfizer Inc, Tempus; Data and Safety Monitoring Boards/Committees: Novartis; Nonrelevant Financial Relationships: MJH Life Sciences, PeerView.

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

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

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Exelixis Inc, Johnson & Johnson, and Novartis.

Release date: August 2026
Expiration date: August 2027

Dr Aggarwal
Agarwal N et al. PARP and androgen-signaling inhibition plus ADT in metastatic prostate cancer. N Engl J Med 2026;395(5):427-39. Abstract

Choudhury A et al. A phase 2 trial of androgen deprivation therapy interruption in patients responding exceptionally to androgen receptor pathway inhibitor in metastatic hormone-sensitive prostate cancer (A-DREAM / Alliance A032101). ASCO 2026;Abstract 5004.

Emmett L et al. AcTION: Phase 1 study of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) in men with metastatic castration-resistant prostate cancer (mCRPC) with or without prior [177Lu]Lu-PSMA (177Lu-PSMA) radioligand therapy (RLT). ASCO 2026;Abstract 5010.

Freedland S et al. EMBARK: Testosterone recovery to >250 ng/dL following treatment suspension. ASCO 2026;Abstract 5088.

Saad F et al. Subgroup analyses by disease volume and de novo/recurrent mHSPC in the PSMAddition study of [177Lu]Lu-PSMA-617. ASCO 2026;Abstract 5020.

Taplin ME et al. Perioperative (neoadjuvant and adjuvant) apalutamide (APA) + androgen deprivation therapy (ADT) vs placebo (PBO) + ADT with radical prostatectomy (RP) in high-risk localized or locally advanced prostate cancer (HR LPC/LAPC): Final analysis of the PROTEUS phase 3 study. ASCO 2026;Abstract LBA1.

Dr Galsky
Bellmunt J et al. Patient-reported outcomes from IMvigor011: A phase 3 study of circulating tumor (ct)DNA–guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (MIBC). ASCO 2026;Abstract 4627.

Daneshmand S et al. TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: Results from the phase IIb SunRISe-1 study. J Clin Oncol 2025;43(33):3578-88. Abstract

De Santis M et al. Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC. ASCO 2026;Abstract 4624.

Powles T et al. Enfortumab vedotin plus pembrolizumab vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma: 3.5-year follow-up and response analyses from the phase 3 EV-302 study. ASCO 2026;Abstract 4507.

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

Vulsteke C et al. Perioperative enfortumab vedotin and pembrolizumab in bladder cancer. N Engl J Med 2026;394(13):1257-69. Abstract

Dr Zhang
Apolo AB et al. Cabozantinib plus nivolumab (C+N) versus sunitinib (S) in patients with advanced renal cell carcinoma (aRCC) and bone metastasis: Updated subgroup analysis of the phase 3 CheckMate-9ER trial. ASCO 2026;Abstract 4528.

Choueiri TK et al. Adjuvant pembrolizumab plus belzutifan versus pembrolizumab for clear cell renal cell carcinoma (ccRCC): The randomized phase 3 LITESPARK-022 study. Genitourinary Cancers Symposium 2026;Abstract LBA418.

Feldman DR et al. Final results of a phase 2 trial of cabozantinib plus nivolumab (CaboNivo) in patients with non–clear cell renal cell carcinoma (nccRCC). ASCO 2026;Abstract 4521.

Larkin J et al. Durvalumab monotherapy versus active monitoring for resected primary renal cell carcinoma in RAMPART: An international, phase 3, randomized controlled trial. ASCO 2026;Abstract LBA4511.

Motzer RJ et al. Belzutifan (bel) plus lenvatinib (lenva) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti–PD-(L)1 therapy: Open-label phase 3 LITESPARK-011 study. Genitourinary Cancers Symposium 2026;Abstract LBA417.

Motzer RJ et al. Efficacy outcomes by patterns of progression in patients with advanced renal cell carcinoma from the phase 3 CLEAR trial. ASCO 2026;Abstract 4527.

Investigators Provide Perspectives on Actual Cases of Metastatic Bladder Cancer

Accreditation types: 0.75 ABIM MOC, ABS MOC, CME

Expires: August 2027

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Faculty

Fern Anari

Faculty

Fern Anari

MD

Fox Chase Cancer Center, Philadelphia, Pennsylvania

Assistant Professor of Genitourinary Medical Oncology

Jacqueline T Brown

Faculty

Jacqueline T Brown

MD

Emory University School of Medicine, Atlanta, Georgia

Assistant Professor, Department of Hematology and Medical Oncology

Catherine Fahey

Faculty

Catherine Fahey

MD, PhD

Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

Assistant Professor, Division of Oncology, Department of Medicine

Yohann Loriot

Faculty

Yohann Loriot

MD, PhD

Gustave Roussy Villejuif, France

Deputy Chair, Early Drug Development (DITEP) Chair, GU Oncology Group Leader, Resistance to Innovative Drugs Program Molecular Predictors and New Targets in Oncology, INSERM U981

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

LEARNING OBJECTIVES

  • Review how biological factors and patient characteristics such as age, performance status, prior treatment, comorbidities and preexisting conditions influence the selection and sequencing of treatment for metastatic urothelial bladder cancer (UBC).
  • Interrogate published efficacy and safety findings with anti-PD-1/PD-L1 antibodies in combination with antibody-drug conjugate (ADC) therapy as first-line treatment for patients with metastatic UBC, and consider the current role of this strategy in patient care.
  • Evaluate available research findings with HER2-directed ADCs for patients with advanced UBC, and optimally integrate these novel agents into management algorithms.
  • Appreciate the frequency and severity of therapy-related adverse events commonly encountered by patients receiving guideline-endorsed agents and regimens for metastatic UBC, and enact effective monitoring and management procedures.
  • Describe the scientific justification for and published research data with novel strategies under investigation for UBC, and effectively prioritize clinical trial opportunities for eligible patients.

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

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

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

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and 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, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

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

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, 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.

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:

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

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

This activity is supported by an educational grant from Pfizer Inc and Astellas.

Release date: August 2026
Expiration date: August 2027

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

Bellmunt J et al. Patient-reported outcomes from IMvigor011: A phase 3 study of circulating tumor (ct)DNA–guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (MIBC). ASCO 2026;Abstract 4627.

Daneshmand S et al. TAR-200 for bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer: Results from the phase IIb SunRISe-1 study. J Clin Oncol 2025;43(33):3578-88. Abstract

De Santis M et al. Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC. ASCO 2026;Abstract 4624.

De Santis M et al. Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): Final analysis of a randomised, open-label, phase 3 trial. Lancet 2025;406(10516):2221-34. Abstract

Galsky MD et al. Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study. Genitourinary Cancers Symposium 2026;Abstract LBA630.

Galsky MD et al. TROPION-Urothelial03: A phase 2/3 study of datopotamab deruxtecan (Dato-DXd) + platinum chemotherapy (CT) vs gemcitabine + platinum CT in participants with locally advanced or metastatic urothelial carcinoma (la/mUC) with progression on or after enfortumab vedotin (EV) + pembrolizumab. ASCO 2026;Abstract TPS4642.

Hoimes CJ et al. Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study. ASCO 2026;Abstract 4614.

O’Donnell PH et al. Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible: Phase 3 KEYNOTE-905 study. ASCO 2026;Abstract 4510.

Powles T et al. Enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): 3.5-year follow-up and response analyses from the phase 3 EV-302 study. ASCO 2026;Abstract 4507.

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

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

Roupret M et al. ALBAN (GETUG-AFU 37): A phase III, randomized, open-label international trial of intravenous atezolizumab and intravesical bacillus Calmette-Guérin (BCG) versus BCG alone in BCG-naive high-risk, non-muscle-invasive bladder cancer (NMIBC). Ann Oncol 2026;37(1):44-52. Abstract

Shore ND et al. Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: The randomized phase 3 CREST trial. Nat Med 2025;31(8):2806-14. Abstract

Vulsteke C et al. Perioperative enfortumab vedotin and pembrolizumab in bladder cancer. N Engl J Med 2026;394(13):1257-69. Abstract

  • Microlearning Activity

Investigators Provide Perspectives on Actual Cases of Metastatic Bladder Cancer

Accreditation types: 0.75 ABIM MOC, ABS MOC, CME

Expires: August 2027

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Faculty

Fern Anari

Faculty

Fern Anari

MD

Fox Chase Cancer Center, Philadelphia, Pennsylvania

Assistant Professor of Genitourinary Medical Oncology

Jacqueline T Brown

Faculty

Jacqueline T Brown

MD

Emory University School of Medicine, Atlanta, Georgia

Assistant Professor, Department of Hematology and Medical Oncology

Catherine Fahey

Faculty

Catherine Fahey

MD, PhD

Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

Assistant Professor, Division of Oncology, Department of Medicine

Yohann Loriot

Faculty

Yohann Loriot

MD, PhD

Gustave Roussy, Villejuif, France

Deputy Chair, Early Drug Development (DITEP), Chair, GU Oncology Group, Leader, Resistance to Innovative Drugs Program, Molecular Predictors and New Targets in Oncology, INSERM U981

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

LEARNING OBJECTIVES

  • Review how biological factors and patient characteristics such as age, performance status, prior treatment, comorbidities and preexisting conditions influence the selection and sequencing of treatment for metastatic urothelial bladder cancer (UBC).
  • Interrogate published efficacy and safety findings with anti-PD-1/PD-L1 antibodies in combination with antibody-drug conjugate (ADC) therapy as first-line treatment for patients with metastatic UBC, and consider the current role of this strategy in patient care.
  • Evaluate available research findings with HER2-directed ADCs for patients with advanced UBC, and optimally integrate these novel agents into management algorithms.
  • Appreciate the frequency and severity of therapy-related adverse events commonly encountered by patients receiving guideline-endorsed agents and regimens for metastatic UBC, and enact effective monitoring and management procedures.
  • Describe the scientific justification for and published research data with novel strategies under investigation for UBC, and effectively prioritize clinical trial opportunities for eligible patients.

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

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

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

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and 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, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

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

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, 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.

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:

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

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

This activity is supported by an educational grant from Pfizer Inc and Astellas.

Release date: August 2026
Expiration date: August 2027

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

Bellmunt J et al. Patient-reported outcomes from IMvigor011: A phase 3 study of circulating tumor (ct)DNA–guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (MIBC). ASCO 2026;Abstract 4627.

Daneshmand S et al. TAR-200 for bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer: Results from the phase IIb SunRISe-1 study. J Clin Oncol 2025;43(33):3578-88. Abstract

De Santis M et al. Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC. ASCO 2026;Abstract 4624.

De Santis M et al. Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): Final analysis of a randomised, open-label, phase 3 trial. Lancet 2025;406(10516):2221-34. Abstract

Galsky MD et al. Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study. Genitourinary Cancers Symposium 2026;Abstract LBA630.

Galsky MD et al. TROPION-Urothelial03: A phase 2/3 study of datopotamab deruxtecan (Dato-DXd) + platinum chemotherapy (CT) vs gemcitabine + platinum CT in participants with locally advanced or metastatic urothelial carcinoma (la/mUC) with progression on or after enfortumab vedotin (EV) + pembrolizumab. ASCO 2026;Abstract TPS4642.

Hoimes CJ et al. Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study. ASCO 2026;Abstract 4614.

O’Donnell PH et al. Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible: Phase 3 KEYNOTE-905 study. ASCO 2026;Abstract 4510.

Powles T et al. Enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): 3.5-year follow-up and response analyses from the phase 3 EV-302 study. ASCO 2026;Abstract 4507.

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

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

Roupret M et al. ALBAN (GETUG-AFU 37): A phase III, randomized, open-label international trial of intravenous atezolizumab and intravesical bacillus Calmette-Guérin (BCG) versus BCG alone in BCG-naive high-risk, non-muscle-invasive bladder cancer (NMIBC). Ann Oncol 2026;37(1):44-52. Abstract

Shore ND et al. Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: The randomized phase 3 CREST trial. Nat Med 2025;31(8):2806-14. Abstract

Vulsteke C et al. Perioperative enfortumab vedotin and pembrolizumab in bladder cancer. N Engl J Med 2026;394(13):1257-69. Abstract

  • Microlearning Activity

Second Opinion: Investigators Provide Perspectives on the Current and Future Management of Small Cell Lung Cancer

Accreditation types: 2.25 ABIM MOC, ABS MOC, CME

Expires: August 2027

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Faculty

Anne Chiang

Faculty

Anne Chiang

MD, PhD

Yale University School of Medicine, New Haven, Connecticut

Associate Professor

Yale Cancer Center, New Haven, Connecticut

Associate Cancer Center Director, Clinical Initiatives

Apar Kishor Ganti

Faculty

Apar Kishor Ganti

MD, MS

University of Nebraska Medical Center, Omaha, Nebraska

Doctor and Mrs D Leon UNMC Research Fund Chair in Internal Medicine, Professor of Medicine, Division of Oncology-Hematology, Professor (Courtesy) of Biochemistry and Molecular Biology

VA Nebraska Western Iowa Health Care System, Omaha, Nebraska

Staff Physician

Luis Paz-Ares

Faculty

Luis Paz-Ares

MD, PhD

Hospital Universitario 12 de Octubre, Madrid, Spain

Chair of the Medical Oncology Department

Universidad Complutense, Madrid, Spain

Professor of Medicine

National Oncology Research Center, Madrid, Spain

Head of the Lung Cancer Unit

Misty Dawn Shields

Moderator

Misty Dawn Shields

MD, PhD

Indiana University School of Medicine, Indianapolis, Indiana

Assistant Professor of Clinical Medicine

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana

Adjunct Assistant Professor of Medical and Molecular Genetics, Associate Member, Experimental and Developmental Therapeutics, Department of Medicine, Division of Hematology/Oncology, Thoracic Oncology

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

LEARNING OBJECTIVES

  • Appraise available findings from clinical studies investigating anti-PD-1/PD-L1 antibody consolidation therapy for patients with limited-stage small cell lung cancer (SCLC) who have not experienced disease progression after standard platinum-based chemotherapy concurrent with radiation therapy, and determine the clinical role of this approach.
  • Review long-term data supporting the use of anti-PD-1/PD-L1 antibodies in combination with platinum-based chemotherapy as first-line therapy for patients with extensive-stage SCLC, and consider how these regimens can be appropriately and safely integrated into clinical practice.
  • Appreciate the biological rationale for the evaluation of maintenance treatment after chemoimmunotherapy induction, and assess available research findings with and the current role of this approach.
  • Evaluate available clinical trial findings with FDA-approved agents for patients with SCLC who experience disease progression on or after platinum-containing first-line therapy, and determine how to optimally integrate these therapies into current treatment algorithms.
  • Interrogate published clinical trial data with DLL3-directed T-cell engager therapy for SCLC, and identify patients with relapsed/refractory (R/R) disease appropriate for this novel approach.
  • Appreciate the incidence of B7-H3 overexpression in patients with SCLC, and develop an understanding of the rationale for, available data with and ongoing studies of B7-H3-directed antibody-drug conjugates for R/R disease.
  • Reflect on the biological rationale for the evaluation of TROP2-directed antibody-drug conjugates for SCLC, and consider available research findings and ongoing studies with these agents.
  • Assess ongoing clinical research studies evaluating other novel agents and treatment strategies for SCLC, and counsel patients regarding the potential benefits of trial participation.

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

CREDIT DESIGNATION STATEMENT
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 this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 2.25 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, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and 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, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

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

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, 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.

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:

Dr Chiang — Advisory Committees: AbbVie Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Janssen Biotech Inc, Merck, Zai Lab; Consulting Agreements: AbbVie Inc, Merck; Contracted Research: AbbVie Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Genentech, a member of the Roche Group, Zai Lab; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP; Honoraria for Lectures: Genentech, a member of the Roche Group, Jazz Pharmaceuticals Inc. Dr Ganti — Advisory Committees: AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Catalyst Pharmaceuticals Inc, Fosun Pharma, Merck, Pfizer Inc, Zai Lab; Consulting Agreements: Cardinal Health, Jazz Pharmaceuticals Inc; Contracted Research: Imugene, Iovance Biotherapeutics, Merck, Mirati Therapeutics Inc, Poseida Therapeutics. Dr Paz-Ares — Advisory Committees: Abbott, AbbVie Inc, Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Daiichi Sankyo Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, Jazz Pharmaceuticals Inc, Lilly, Merck, Novartis, Pfizer Inc, Regeneron Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, MSD, Pfizer Inc; Board Memberships: Altum Sequencing, STAb Therapeutics.

CONTRIBUTING CLINICAL INVESTIGATORS
Charu Aggarwal, MD — Consulting Agreements: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genmab US Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck. Ticiana Leal, MD — Advisory Committees: Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Catalyst Pharmaceuticals Inc, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Merck, Molecular Partners, Novocure Inc, Nuvation Bio Inc, Roche Laboratories Inc, Summit Therapeutics, Synthekine, Verastem Inc; Consulting Agreements: AbbVie Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Catalyst Pharmaceuticals Inc, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Molecular Partners, Novocure Inc; Contracted Research (to Institution): Daiichi Sankyo Inc; Data and Safety Monitoring Boards/Committees: OncoC4; Travel Support: Amgen Inc, Novocure Inc.

MODERATOR — Dr Shields — Steering Committees: AstraZeneca Pharmaceuticals LP.

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

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

This activity is supported by educational grants from Amgen Inc, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, and Merck.

Release date: August 2026
Expiration date: August 2027

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

Dr Shields

Ahn M-J et al. Tarlatamab for patients with previously treated small-cell lung cancer. N Engl J Med 2023;389(22):2063-75. Abstract

Dowlati A et al. Phase 2 open-label study of sacituzumab govitecan as second-line therapy in patients with extensive-stage SCLC: Results from TROPiCS-03. J Thorac Oncol 2025;20(6):799-808. Abstract

Mountzios G et al. Tarlatamab in small-cell lung cancer after platinum-based chemotherapy. N Engl J Med 2025;393(4):349-61. Abstract

Paulson KG et al. Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): A multicentre, non-randomised, phase 1b study. Lancet Oncol 2025;26(10):1300-11. Abstract

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

Reck M et al. Five-year survival in patients with extensive-stage small cell lung cancer treated with atezolizumab in the phase III IMpower133 study and the phase III IMbrella A extension study. Lung Cancer 2024;196:107924. Abstract

Rudin CM et al. Ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer: Primary analysis of the phase II IDeate-Lung01 trial. J Clin Oncol 2026;44(4):261-73. Abstract

Trigo J et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: A single-arm, open-label, phase 2 basket trial. Lancet Oncol 2020;21(5):645-54. Abstract

Dr Paz-Ares

Ahn M-J et al. Tarlatamab for patients with previously treated small-cell lung cancer. N Engl J Med 2023;389(22):2063-75. Abstract

Ai X et al. A phase 2 dose expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer. ASCO 2025;Abstract 8007.

Beltran H et al. Updated results from a phase 1/2 study of HPN328, a tri-specific, half-life (T1/2) extended DLL3-targeting T-cell engager in patients (pts) with small cell lung cancer (SCLC) and other neuroendocrine cancers (NEC). ASCO 2024;Abstract 8090.

Mountzios G et al. Tarlatamab in small-cell lung cancer after platinum-based chemotherapy. N Engl J Med 2025;393(4):349-61. Abstract

Paz-Ares LG et al. Efficacy and safety of lurbinectedin (LUR) with irinotecan (IRI) in patients (Pts) with relapsed small cell lung cancer (SCLC): Results from a phase 2 expansion cohort. ASCO 2024;Abstract 8094.

Ponce S et al. Combination of lurbinectedin plus irinotecan: Preclinical and early clinical results in patients with relapsed SCLC. J Thorac Oncol 2026;21(7):103654. Abstract

Ponce Aix S et al. Safety and efficacy of lurbinectedin plus atezolizumab as second-line treatment for advanced small-cell lung cancer: Results of the 2SMALL phase 1/2 study (NCT04253145). ASCO 2025;Abstract 8013.

Ponce Aix S et al. Combination lurbinectedin and doxorubicin versus physician’s choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): A multicentre, randomised, open-label, phase 3 trial. Lancet Respir Med 2023;11(1):74-86. Abstract

Trigo J et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: A single-arm, open-label, phase 2 basket trial. Lancet Oncol 2020;21(5):645-54. Abstract

Wermke M et al. DAREON-9, a phase Ib study of obrixtamig plus topotecan in patients (pts) with advanced small cell lung cancer (SCLC): Interim analysis results. ASCO 2025;Abstract 8094.

Dr Chiang

Dowlati A et al. Phase 2 open-label study of sacituzumab govitecan as second-line therapy in patients with extensive-stage SCLC: Results from TROPiCS-03. J Thorac Oncol 2025;20(6):799-808. Abstract

Patel MR et al. ZL-1310, a DLL3 ADC, in patients with extensive stage small cell lung cancer: Ph1 trial update. ASCO 2025;Abstract 3041.

Rudin CM et al. Ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer: Primary analysis of the phase II IDeate-Lung01 trial. J Clin Oncol 2026;44(4):261-73. Abstract

Simoes da Rocha PF et al. Intracranial activity of ifinatamab deruxtecan (I-DXd) in patients (pts) with extensive-stage (ES) small cell lung cancer (SCLC) and baseline (BL) brain metastases (BM): Primary analysis of IDeate-Lung01. ESMO 2025;Abstract 2760MO.

Dr Ganti

Bogart J et al. High-dose once-daily thoracic radiotherapy in limited-stage small-cell lung cancer: CALGB 30610 (Alliance)/RTOG 0538. J Clin Oncol 2023;41(13):2394-402. Abstract

Cheng Y et al. Durvalumab after chemoradiotherapy in limited-stage small-cell lung cancer. N Engl J Med 2024;391(14):1313-27. Abstract

Mountzios G et al. Tarlatamab in small-cell lung cancer after platinum-based chemotherapy. N Engl J Med 2025;393(4):349-61. Abstract

Walls GM et al. Long-term outcomes after concurrent once- or twice-daily chemoradiation in limited-stage small cell lung cancer: A brief report from the CONVERT trial. Int J Radiat Oncol Biol Phys 2024;119(5):1386-90. Abstract

Consensus or Controversy? Documenting and Discussing Investigators’ Approaches to the Management of Advanced Gastroesophageal Cancers

Accreditation types: 1.75 ABIM MOC, ABS MOC, CME

Expires: August 2027

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Faculty

Manish A Shah

Faculty

Manish A Shah

MD

Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York

Professor of Medicine, Bartlett Family Professor of Gastrointestinal Oncology, Chief, Solid Tumor Oncology

Eric Van Cutsem

Faculty

Eric Van Cutsem

MD, PhD

University Hospitals Leuven, Leuven, Belgium

Professor of Medicine, Digestive Oncology

Yelena Y Janjigian

Moderator

Yelena Y Janjigian

MD

Memorial Sloan Kettering Cancer Center, New York, New York

Carroll and Milton Petrie Chair, Professor and Chief Attending, Gastrointestinal Oncology Service

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

LEARNING OBJECTIVES

  • Assess available data with claudin 18.2 (CLDN18.2)-directed monoclonal antibody therapy in combination with chemotherapy as first-line treatment for patients with HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction (GEJ) cancer, and optimally incorporate this approach into management algorithms.
  • Review published research findings with HER2-targeted therapies for patients with HER2-positive gastroesophageal cancers, and assess the current nonresearch role of various agents and regimens.
  • Describe the published research data with anti-PD-1/PD-L1 antibodies alone or in combination with other systemic therapies in the management of metastatic gastric, GEJ and esophageal cancer, and optimally integrate these strategies into treatment algorithms.
  • Recognize the spectrum, frequency and severity of toxicities associated with agents and regimens with established activity in advanced gastroesophageal cancers in order to facilitate the safe and effective use of these therapies.

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

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.75 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for 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, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and 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, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

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

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, 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.

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 — Dr Shah has no relevant financial relationships to disclose. The following faculty reported relevant financial relationships with ineligible entities:

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

CONTRIBUTING CLINICAL INVESTIGATORS
Sunnie Kim, MD — Advisory Committees: AstraZeneca Pharmaceuticals LP, BeOne, Takeda Pharmaceuticals USA Inc; Consulting Agreements: Amgen Inc; Contracted Research: Merck; Data and Safety Monitoring Boards/Committees: Jazz Pharmaceuticals Inc. Samuel J Klempner, MD — Advisory Committees: Astellas, AstraZeneca Pharmaceuticals LP, BeOne, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology, EsoBiotec, Gilead Sciences Inc, I-Mab Biopharma, Jazz Pharmaceuticals Inc, Merck, Mersana Therapeutics Inc, Natera Inc, Novartis, Signet Therapeutics, Taiho Oncology Inc; Consulting Agreements: Astellas; Contracted Research: Arcus Biosciences, AstraZeneca Pharmaceuticals LP, I-Mab Biopharma, Mersana Therapeutics Inc, Parabilis Medicines; Data and Safety Monitoring Boards/Committees: Sanofi; Stock Options — Private Companies: MBrace Therapeutics; Nonrelevant Financial Relationships: Debbie’s Dream Foundation, Degregorio Family Foundation, Gastric Cancer Foundation, National Cancer Institute/National Institutes of Health, NCCN (member of Gastric and Esophageal Guidelines Committees), Stand Up 2 Cancer/AACR, Torrey Coast Foundation. Zev Wainberg, MD, MSc — Consulting Agreements: AbbVie Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Daiichi Sankyo Inc, EMD Serono Inc, Gilead Sciences Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Lilly, Merck, Novartis, Novocure Inc, Pfizer Inc, Regeneron Pharmaceuticals Inc, Takeda Pharmaceuticals USA Inc; Contracted Research: Arcus Biosciences, Bristol Myers Squibb; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP, Pfizer Inc.

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

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

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

This activity is supported by educational grants from Astellas and Jazz Pharmaceuticals Inc.

Release date: August 2026
Expiration date: August 2027

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

Prof Van Cutsem
Elimova E et al. Characterization and management of gastrointestinal (GI) adverse events (AEs) with zanidatamab + chemotherapy (CT) ± tislelizumab in first-line (1L) HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (mGEA): Analysis from HERIZON-GEA-01. ASCO 2026;Abstract 4042.

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

Kawazoe A et al. KEYNOTE-811: 6-year median follow-up of pembrolizumab plus trastuzumab and chemotherapy for previously untreated advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma. ASCO 2026;Abstract 4040.

Liu R et al. Anbenitamab in previously treated HER2-positive gastric cancer (KC-WISE): Prespecified interim analysis of a randomized, phase III clinical trial. Ann Oncol 2026;37(6):777-86. Abstract

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

Rha SY et al. Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (mGEA): PD-L1 subgroup analysis from HERIZON-GEA-01. ASCO 2026;Abstract 4010.

Shitara K et al. Additional health-related quality of life (HRQoL) analysis from DESTINY-Gastric04 (DG-04), a randomized phase 3 study of trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) + paclitaxel (PTX) in patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic gastric cancer (GC)/gastroesophageal junction adenocarcinoma (GEJA). ASCO 2026;Abstract 4111.

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

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

Dr Shah
Baek JH et al. Clinical implications of claudin18.2 expression in patients with gastric cancer. Anticancer Res 2019;39(12):6973-9. Abstract

Klempner SJ et al. Consensus guidance for prevention and management of nausea and vomiting in patients treated with zolbetuximab + chemotherapy: A RAND/UCLA modified Delphi panel study. ESMO Gastrointest Oncol 2025;7:100131. Abstract

Lordick F et al. Health-related quality of life in patients with CLDN18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: Results from the SPOTLIGHT and GLOW clinical trials. ESMO Open 2024;9(8):103663. Abstract

Maeng CH et al. Clinicopathologic correlates of claudin 18.2 expression in esophagogastric cancer at multiple expression levels. ESMO Gastrointest Oncol 2026;11:100278. Abstract

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

Shitara K et al. Zolbetuximab + pembrolizumab and chemotherapy as first-line treatment for patients with CLDN18.2-positive, HER2-negative, PD-L1-positive locally advanced unresectable or metastatic G/GEJ adenocarcinoma: Phase 3, double-blind, randomized trial (LUCERNA). Gastrointestinal Cancers Symposium 2026;Abstract TPS473.

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

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

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

Cruz-Correa M et al. Tislelizumab + chemotherapy in gastric cancer: Long-term RATIONALE-305 randomized trial follow-up. Adv Ther 2026;43(1):165-83. Abstract

Janjigian YY et al. Nivolumab plus chemotherapy as first-line treatment for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: 5-year follow-up results from CheckMate 649. Ann Oncol 2026;37(6):787-97. Abstract

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

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

Janjigian YY et al. CheckMate-032 study: Efficacy and safety of nivolumab and nivolumab plus ipilimumab in patients with metastatic esophagogastric cancer. J Clin Oncol 2018;36(28):2836-44. Abstract

Metges J-P et al. Pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer: 5-year extended follow-up for the randomized phase III KEYNOTE-590 study. ESMO Open 2025;10(12):105854. Abstract

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

Oh D-Y et al. Nivolumab plus ipilimumab combined with chemotherapy as first-line treatment for HER2-negative unresectable advanced or recurrent gastric/gastroesophageal junction cancer: A randomized phase 3 trial (ATTRACTION-6). ASCO 2026;Abstract 4006.

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

Rha SY et al. KEYNOTE-859: 4.5-year median follow-up of pembrolizumab plus chemotherapy for previously untreated advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. ASCO 2025;Abstract 4036.

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

Shah MA et al. First-line pembrolizumab (pembro) plus chemotherapy (chemo) for advanced esophageal cancer: 5-year outcomes from the phase 3 KEYNOTE-590 study. Gastrointestinal Cancers Symposium 2024;Abstract 250.

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

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

Yoon HY et al. Tislelizumab (TIS) + chemotherapy (CT) vs placebo (PBO) + CT as first-line treatment for locally advanced (LA), unresectable esophageal squamous cell carcinoma (ESCC): PD-L1 tumor area positivity (TAP) score ≥1% subgroup analysis of RATIONALE-306. Gastrointestinal Cancers Symposium 2026;Abstract 381.