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

Faculty

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

Faculty

Eric Van Cutsem

MD, PhD

University Hospitals Leuven, Leuven, Belgium

Professor of Medicine, Digestive Oncology

Moderator

Yelena Y Janjigian

MD

Memorial Sloan Kettering Cancer Center, New York, New York

Professor and Chief Attending, Gastrointestinal Oncology Service

Program Schedule — Central Time
11:15 AM – 11:30 AM — Registration
11:30 AM – 1:00 PM — Educational Lunch Meeting

MODULE 1: Targeting CLDN18.2 in Advanced Gastroesophageal Cancers

• Incidence and clinical relevance of CLDN18.2 expression in gastric and gastroesophageal junction (GEJ) cancer; appropriate methods to assess CLDN18.2 status
• Key efficacy and safety results from the Phase III SPOTLIGHT and GLOW trials evaluating zolbetuximab in combination with chemotherapy as first-line treatment for CLDN18.2-positive advanced gastric/GEJ adenocarcinoma
• FDA approval and current clinical role of up-front zolbetuximab/chemotherapy
• Spectrum, frequency and severity of adverse events associated with zolbetuximab; optimal approaches to prevention and management
• Recently presented results with zolbetuximab in combination with modified FOLFOX6 and nivolumab for patients with CLDN18.2-positive advanced gastric or GEJ adenocarcinoma in the Phase II ILUSTRO trial; implications for current and future practice
• Design, eligibility criteria and key efficacy and safety endpoints of the Phase III LUCERNA trial evaluating zolbetuximab in combination with pembrolizumab and chemotherapy as first-line treatment for CLDN18.2-positive, HER2-negative, PD-L1-positive gastric/GEJ cancer
• Structural components of the CLDN18.2-targeted antibody-drug conjugate sonesitatug vedotin and early efficacy and safety results with this therapy for advanced gastroesophageal cancers

MODULE 2: HER2-Targeted Approaches for Advanced Gastroesophageal Cancers

• Available efficacy and safety findings with and current clinical role of trastuzumab/pembrolizumab/chemotherapy for patients with untreated HER2-positive advanced gastric/GEJ adenocarcinoma
• Mechanism of action of the novel HER2-targeted bispecific antibody zanidatamab
• Early research findings with zanidatamab/chemotherapy as first-line treatment for advanced HER2-positive gastroesophageal adenocarcinoma
• Design, eligibility criteria and key efficacy and safety endpoints from the Phase III HERIZON-GEA-01 trial evaluating zanidatamab/chemotherapy with or without tislelizumab as first-line treatment for gastroesophageal adenocarcinoma
• Recently presented results from the HERIZON-GEA-01 trial demonstrating a progression-free survival (PFS) and overall survival advantage with zanidatamab/chemotherapy/tislelizumab and a PFS benefit with zanidatamab/chemotherapy; implications for current and future disease management
• Spectrum, frequency and optimal approaches to the management of toxicities associated with zanidatamab
• Published efficacy and safety data from the Phase III DESTINY-Gastric04 trial comparing trastuzumab deruxtecan (T-DXd) to ramucirumab/paclitaxel for patients with HER2-positive metastatic gastric cancer or GEJ adenocarcinoma who had previously received trastuzumab-based therapy
• Optimal integration of T-DXd into the current management of advanced HER2-positive gastroesophageal tumors

MODULE 3: Available Immunotherapeutic Strategies for Advanced Gastroesophageal Cancers

• Clinical and biological factors in the choice of up-front therapy for patients with metastatic gastroesophageal cancers
• Published datasets demonstrating the efficacy and safety of first-line nivolumab-, pembrolizumab- and tislelizumab-containing regimens for advanced HER2-negative gastric, GEJ and esophageal cancers; impact of PD-L1 expression on outcomes
• Recent narrowing of the FDA-approved indications for nivolumab- and pembrolizumab-containing regimens for previously untreated HER2-negative gastroesophageal cancers
• Clinical utility, if any, of immunotherapy for relapsed/refractory gastroesophageal tumors
• Optimal approaches to the prevention and management of toxicities observed with immune checkpoint inhibitors

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
Upon completion of this activity, participants should be able to

• 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 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.

CME Credit Form
A CME credit link will be given to each participant as part of the meeting course materials.

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

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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. 

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, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

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

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

Hilton Chicago
720 South Michigan Avenue
Chicago, IL 60605
Phone: (312) 922-4400

Meeting Room
Continental Room A (Lobby Level)

Directions
The Hilton Chicago hotel is located just 5 minutes (2.5 miles) north of the McCormick Place convention center, where the ASCO Annual Meeting is taking place.