Pembrolizumab versus paclitaxel for previously treated advanced gastric or gastroesophageal junction cancer (KEYNOTE-063): A randomized, open-label, phase 3 trial in Asian patients.

"Conflict of Interest Disclosures Hyun Cheol Chung reports grants (for research to institution) from Amgen, Bristol‐Myers Squibb/Ono, Eli Lilly, GSK, Incyte, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, Merck‐Serono, Taiho, and Zymework; honoraria from Eli Lilly and Merck‐Serono; and consultancy fees from Amgen, BeiGene, Bristol‐Myers Squibb, Celltrion, Eli Lilly, Gloria, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, Merck‐Serono, Quintiles, Taiho, and Zymeworks. Yoon‐Koo Kang reports advisory fees from ALX Oncology, Amgen, Bristol‐Myers Squibb, Daehwa, Macrogenics, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, Novartis, Surface Oncology, and Zymeworks. Wan Zamaniah Wan Ishak reports honoraria for lectures from Amgen Malaysia, DKSH Malaysia, Eisai Malaysia, Eli Lilly Malaysia, Ipsen Malaysia, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, Merck Serono Malaysia, Pfizer Malaysia, and Roche Malaysia; travel grants from Amgen Malaysia, Celgene Malaysia, Eisai Malaysia, Eli Lilly Malaysia, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, and Roche Malaysia; and is an advisory board member for Celgene Malaysia, Eli Lilly Malaysia, Eisai Malaysia, and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey. Wen Yan Zhong is an employee of MSD China, Beijing, China. Shu Kuang is an employee of MSD China, Beijing, China. Chie‐Schin Shih is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey and a stockholder of Merck & Co., Inc., Kenilworth, New Jersey."

"Medical writing and/or editorial assistance was provided by Kathleen Richards, PhD, and Holly C. Cappelli, PhD, CMPP, of ApotheCom (Yardley, Pennsylvania). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey."

"This study planned to enroll 360 patients; the timing of the final analysis was event driven. After 290 OS events had been observed, the study was expected to have ~91% power to demonstrate the superiority of pembrolizumab compared with paclitaxel in this setting at a 1‐sided α of 0.0215 if the underlying HR for OS was 0.67. However, because of early termination of the study, statistical power is lacking for the current analysis, which used a database cutoff date of October 8, 2019. This trial is registered with ClinicalTrials.gov (NCT03019588). This trial is registered at ClinicalTrials.gov (NCT03019588)."