Checkmate 64912/13/2023 Hierarchically tested secondary endpoints included OS in NIVO + chemo vs chemo (PD-L1 CPS ≥ 1, then all randomized). Dual primary endpoints were OS and PFS (per blinded independent central review) in pts with PD-L1 combined positive score (CPS) ≥ 5 for NIVO + chemo vs chemo. Pts were randomized to NIVO (360 mg Q3W or 240 mg Q2W) + chemo (XELOX Q3W or FOLFOX Q2W), NIVO 1 mg/kg + IPI 3 mg/kg Q3W (4 doses, then NIVO 240 mg Q2W), or chemo. Pts with known HER2-positive status were excluded. Methods: Adults with previously untreated, unresectable advanced or metastatic GC/GEJC/EAC were enrolled regardless of PD-ligand (L)1 expression. We present expanded analyses of NIVO + chemo vs chemo with minimum follow-up of 24 mo. Clinically meaningful long-term survival benefit with NIVO + chemo vs chemo was observed with 24 months (mo) of minimum follow-up in all randomized patients (pts) for both OS (HR 0.79 ) and progression-free survival (PFS HR 0.79 Janjigian YY et al ESMO 2021). National Cancer Center Hospital East, Kashiwa, Japan Memorial Sloan Kettering Cancer Center, New York, NY Johannes-Gutenberg University Clinic, Mainz, Germany Clinica San Carlos de Apoquindo, Pontificia Universidad Católica, Santiago, Chile Fundación Arturo López Pérez, Santiago, Chile Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, China The Cancer Institute Hospital of JFCR, Tokyo, Japan Klinika Onkologii i Radioterapii, Narodowy Instytut Onkologii, Warszawa, Poland II Klinika Chirurgii Ogólnej, Gastroenterologicznej i Nowotworów Układu Pokarmowego, Medical University of Lublin, Lublin, Poland Fundacao Pio Xii Hosp Cancer De Barretos, Barretos, Brazil Zhongshan Hospital Fudan University, Shanghai, China Oncology Center–Centre Hospitalier de l’université de Montreal, Montréal, QC, Canada Princess Margaret Cancer Centre, Toronto, ON, Canada Bristol Myers Squibb, Princeton, NJ The University of Texas MD Anderson Cancer Center, Houston, TXīackground: CheckMate 649 is a randomized, global phase 3 study of 1L programmed death-1 (PD-1) inhibitor–based therapies in advanced non-HER2-positive GC/GEJC/EAC that demonstrated superior overall survival (OS) with NIVO + chemo vs chemo, leading to approvals in the US and other countries.
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