![]() ![]() Safety results are described in the table. Statistically significant OS benefit was also observed in pts with PD-L1 CPS ≥ 1 and the all-randomized population (Table). With a minimum follow-up of 12 months (mo), NIVO + chemo showed a statistically significant improvement in OS and PFS vs chemo in pts whose tumors expressed PD-L1 CPS ≥ 5 (OS, HR 0.71 and PFS, HR 0.68 ). Resultsġ581 pts were concurrently randomized in nivo+chemo and chemo arms, including 955 pts (60%) with PD-L1 CPS ≥ 5. Dual primary endpoints for NIVO + chemo vs chemo were OS and PFS by blinded independent central review, in pts whose tumors expressed PD-L1 CPS ≥ 5. Pts were randomized to receive NIVO (360 mg Q3W or 240 mg Q2W) + chemo (XELOX Q3W or FOLFOX Q2W), NIVO + ipilimumab, or chemo. Pts with known HER2-positive status were excluded. MethodsĪdults with previously untreated, unresectable advanced, or metastatic GC/GEJC/EAC were enrolled, regardless of PD-L1 expression. We report OS at a pre-specified interim analysis and progression-free survival (PFS) at final analysis from the NIVO + chemo vs chemo arms in patients (pts) whose tumors expressed PD-ligand 1 (L1) combined positive score (CPS) ≥ 5. CheckMate 649 is the largest randomized, global phase III study of programmed death (PD)-1 inhibitor-based therapies in 1L GC/GEJC/EAC. Standard 1L chemo options for advanced or metastatic HER2-negative GC/GEJC result in poor overall survival (OS median < 1 year). 20 Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center and Weil Cornell Medical College, 10065 - New York/US.19 Gastrointestinal Medical Oncology, Division Of Cancer Medicine, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US.18 Oncology Clinical Research, Bristol-Myers Squibb Company, 08540 - Princeton/US.17 Gastric And Esophageal Cancer, Bristol-Myers Squibb Company, 08540 - Princeton/US.16 Clinical Pharmacology, Bristol-Myers Squibb Company, 08540 - Princeton/US.15 Oncology Clinical Development, Bristol-Myers Squibb Company, 08540 - Princeton/US.14 Biostats, Bristol-Myers Squibb Company, 08540 - Princeton/US.13 Oncology Center, Centre Hospitalier de l'Universite de Montreal, H2X OC1 - Montréal/CA.12 Oncology, Universidad de La Frontera, 4780000 - Temuco/CL.11 Medical Oncology, SF Nectarie Oncology Center, 200347 - Craiova/RO.10 Medical Oncology, Zhongshan Hospital Fudan University, 200000 - Shanghai/CN.9 Medical Oncology, Fundacao Pio Xii Hosp Cancer De Barretos, 14784400 - Barretos, SP/BR.8 Ii Klinika Chirurgii Ogólnej, Gastroenterologicznej I Nowotworów Układu Pokarmowego, Medical University of Lublin, 20-081 - Lublin/PL.7 Gastroenterological Chemotherapy, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP.6 Klinika Onkologii I Radioterapii, Narodowy Instytut Onkologii, 02-034 - Warszawa/PL.5 Gastrointestinal Oncology, Key Laboratory Of Carcinogenesis And Translational Research (ministry Of Education/beijing), Beijing Cancer Hospital, 100142 - Beijing/CN.4 Medical Oncology, Fundación Arturo López Pérez, 750-0921 - Providencia/CL. ![]() 3 Hemato-oncology, Clinica San Carlos de Apoquindo, Pontificia Universidad Católica, 7550000 - Santiago RM/CL.2 Gastroenterology And Gastrointestinal Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP.1 Gastroenterology / Endosonography, Johannes-Gutenberg University Clinic, 55131 - Mainz/DE.
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