Pembrolizumab versus paclitaxel for previously treated PD-L1-positive advanced gastric or gastroesophageal junction cancer: 2-year update of the randomized phase 3 KEYNOTE-061 trial.

"Declarations Conflict of interestCharles S. Fuchs reports board membership (director of board) for CytomX; consultancy for Agios, Amylin Pharmaceuticals, AstraZeneca, Bain Capital, CytomX Therapeutics, Daiichi-Sankyo, Eli Lilly, Entrinsic Health, Genentech, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Taiho, and Unum Therapeutics; expert testimony for Amylin Therapeutics and Eli Lilly; unexercised stock options for CytomX and Entrinsic Health; and co-founder of EvolveImmune Therapeutics. Mustafa Özgüroğlu has nothing to disclose. Yung-Jue Bang reports consultancy for Astellas Pharma, AstraZeneca, Bayer, BeiGene, BMS, Daiichi-Sankyo, Eli Lilly, Genentech/Roche, Genexine, GreenCross, Hanmi, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Merck Serono, Novartis, Samyang Biopharm, and Taiho; and grants from Astellas Pharma, AstraZeneca, Bayer, BeiGene, Boehringer-Ingelheim, BMS, Boston Biomedical, CKD Pharma, Curis, Daiichi-Sankyo, Eli Lilly, FivePrime, Genentech/Roche, Genexine, GreenCross, GSK, Macrogenics, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Merck Serono, Novartis, Ono, Pfizer, Taiho, and Takeda. Maria Di Bartolomeo has nothing to disclose. Mario Mandala reports board membership for Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Roche; and grants from BMS, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Roche. Min-Hee Ryu reports honoraria from and advisory boards for AstraZeneca, BMS, Daehwa Pharmaceutical, Lilly, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Novartis, Ono, and Taiho; payment for lectures from BMS, Daehwa Pharmaceutical, Lilly, and Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Lorenzo Fornaro reports board membership for Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA; payment for lectures, including service on speakers bureaus, from Eli Lilly; and travel/accommodations/meeting expenses from Celgene. Tomasz Olesinski has nothing to disclose. Christian Caglevic reports consultancy for Andes Biotechnologies, Boehringer Ingelheim, BMS, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Roche; payment for lectures, including service on speakers bureaus, from BMS, Lilly, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Roche; travel/accommodations/meeting expenses from Roche; and service as a clinical trial investigator for Astellas Pharma, AstraZeneca, BMS, GSK, Medivation, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Roche. Hyun C. Chung reports consultancy for Amgen, BeiGene, BMS, Celltrion, Gloria, Lilly, Merck-Serono, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Taiho, Zymework; and grants from Amgen, BeiGene, BMS/Ono, GSK Incyte, Lilly, Merck-Serono, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Taiho. Kei Muro reports grants from Astellas Pharma, Amgen Biopharma, Daiichi Sankyo, Merck-Serono, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Parexel International, Ono, Pfizer, Sanofi, Solasia Pharma, and Taiho; and consulting fees or honoraria from Amgen, AstraZeneca, Bayer, BMS, Chugai, Eli Lilly, Ono Pharmaceutical, Sanofi, Taiho, and Takeda. Eric Van Cutsem reports consultancy for Array, Astellas Pharma, AstraZeneca, Bayer, Biocartis, BMS, Celgene, Daichi-Sankyo, GSK, Halozyme, Incyte, Ipsen, Lilly, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Merck KGaA, Novartis, Pierre-Fabre, Roche, Servier, Sirtex, and Taiho; and grants from Amgen, Bayer, Boehringer-Ingelheim, BSM, Celgene, Ipsen, Lilly, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Merck KGaA, Novartis, Roche, and Servier. Anneli Elme has nothing to disclose. Peter Thuss-Patience reports consulting fees or honoraria from AstraZeneca, BMS, Lilly, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Merck Serono, Pfizer, Roche, and Servier. Ian Chau reports advisory boards for AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Five Prime Therapeutics, Merck-Serono, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Oncologie International, Pierre Fabre, Roche; research funding from Eli Lilly, Janssen-Cilag, and Sanofi Oncology; and honorarium from Eli Lilly. Atsushi Ohtsu reports personal fees from BMS, Chugai, Ono, and Taiho. Pooja Bhagia is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Anran Wang is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Chie-Schin Shih is an employee and stockholder of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Kohei Shitara reports consultancy with AbbVie, Astellas Pharma, BMS, Eli Lilly, GSK, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Novartis, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical, and Takeda Pharmaceutical; grants from Astellas Pharma, Chugai Pharma, Dainippon Sumitomo Pharma, Daiichi Sanyko, Eli Lilly, Medi Science, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Ono Pharmaceutical, and Taiho Pharmaceutical; and honoraria (lecture fees) from AbbVie, Novartis, and Yakult. Ethical approvalThe study protocol and all amendments were approved by the institutional review board or ethics committee at each institution. Ethical standardsAll procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. Informed consent to be included in the study, or the equivalent, was obtained from all patients. Informed consentWritten informed consent was provided by all patients before enrollment. Conflict of interest Charles S. Fuchs reports board membership (director of board) for CytomX; consultancy for Agios, Amylin Pharmaceuticals, AstraZeneca, Bain Capital, CytomX Therapeutics, Daiichi-Sankyo, Eli Lilly, Entrinsic Health, Genentech, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Taiho, and Unum Therapeutics; expert testimony for Amylin Therapeutics and Eli Lilly; unexercised stock options for CytomX and Entrinsic Health; and co-founder of EvolveImmune Therapeutics. Mustafa Özgüroğlu has nothing to disclose. Yung-Jue Bang reports consultancy for Astellas Pharma, AstraZeneca, Bayer, BeiGene, BMS, Daiichi-Sankyo, Eli Lilly, Genentech/Roche, Genexine, GreenCross, Hanmi, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Merck Serono, Novartis, Samyang Biopharm, and Taiho; and grants from Astellas Pharma, AstraZeneca, Bayer, BeiGene, Boehringer-Ingelheim, BMS, Boston Biomedical, CKD Pharma, Curis, Daiichi-Sankyo, Eli Lilly, FivePrime, Genentech/Roche, Genexine, GreenCross, GSK, Macrogenics, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Merck Serono, Novartis, Ono, Pfizer, Taiho, and Takeda. Maria Di Bartolomeo has nothing to disclose. Mario Mandala reports board membership for Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Roche; and grants from BMS, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Roche. Min-Hee Ryu reports honoraria from and advisory boards for AstraZeneca, BMS, Daehwa Pharmaceutical, Lilly, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Novartis, Ono, and Taiho; payment for lectures from BMS, Daehwa Pharmaceutical, Lilly, and Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Lorenzo Fornaro reports board membership for Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA; payment for lectures, including service on speakers bureaus, from Eli Lilly; and travel/accommodations/meeting expenses from Celgene. Tomasz Olesinski has nothing to disclose. Christian Caglevic reports consultancy for Andes Biotechnologies, Boehringer Ingelheim, BMS, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Roche; payment for lectures, including service on speakers bureaus, from BMS, Lilly, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Roche; travel/accommodations/meeting expenses from Roche; and service as a clinical trial investigator for Astellas Pharma, AstraZeneca, BMS, GSK, Medivation, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Roche. Hyun C. Chung reports consultancy for Amgen, BeiGene, BMS, Celltrion, Gloria, Lilly, Merck-Serono, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Taiho, Zymework; and grants from Amgen, BeiGene, BMS/Ono, GSK Incyte, Lilly, Merck-Serono, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Taiho. Kei Muro reports grants from Astellas Pharma, Amgen Biopharma, Daiichi Sankyo, Merck-Serono, Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Parexel International, Ono, Pfizer, Sanofi, Solasia Pharma, and Taiho; and consulting fees or honoraria from Amgen, AstraZeneca, Bayer, BMS, Chugai, Eli Lilly, Ono Pharmaceutical, Sanofi, Taiho, and Takeda. Eric Van Cutsem reports consultancy for Array, Astellas Pharma, AstraZeneca, Bayer, Biocartis, BMS, Celgene, Daichi-Sankyo, GSK, Halozyme, Incyte, Ipsen, L"

"Funding This work was supported by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. The sponsor collaborated jointly with the senior academic authors to design the study and gather, analyze, and interpret the results. All authors had access to the data and final responsibility for the decision to submit the manuscript for publication. The sponsor funded medical writing and/or editorial assistance for this manuscript."

"Trial registration ClinicalTrials.gov, NCT02370498"