ResultsĪt data cutoff, 749 pts (83% male, 73% ESCC) were randomized (373 pembro + chemo 376 chemo). Data cutoff for interim OS/final PFS analysis was July 2, 2020. The secondary end point was ORR (RECIST v1.1 by investigator) in all pts. Primary end points were OS in pts with ESCC PD-L1 combined positive score (CPS) ≥10 tumors, and OS and PFS (RECIST v1.1 by investigator) in ESCC, PD-L1 CPS ≥10, and all pts. Treatment continued until progression, unacceptable toxicity, or withdrawal, or 2 yr. Randomization was stratified by Asia vs Rest of World, adenocarcinoma vs ESCC, and ECOG PS 0 vs 1. MethodsĮligible pts were randomized 1:1 to pembro 200 mg or placebo Q3W for up to 2 yr + chemo (cisplatin 80 mg/m2 Q3W + 5-FU 800 mg/m2 on d1-5 Q3W). KEYNOTE-590 (NCT03189719) is a randomized, international, double-blind study of 1L pembrolizumab (pembro) + chemotherapy (chemo) vs chemo alone in patients (pts) with locally advanced/unresectable or metastatic adenocarcinoma or esophageal squamous cell carcinoma (ESCC) or Siewert type 1 esophagogastric junction adenocarcinoma (EGJ). 18 Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, 100142 - Beijing/CN.17 Medical Oncology, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., 07033 - Kenilworth/US.16 Hematology-oncology, Hematology Oncology Practice Eppendorf, and University Cancer Center Hamburg, 20249 - Hamburg/DE.15 Medical Oncology, Vall d’Hebron Institute of Oncology, 08035 - Barcelona/ES.14 Medicine, Prince of Songkla University Hospital, 90110 - Songkhla/TH.13 Oncology And Hematology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung/TW.12 Medical Oncology, Christie Hospital NHS Trust, M20 4BX - Manchester/GB.11 Yonsei Cancer Center, Severance Hospital, Yonsei University Health System, 3722 - Seoul/KR.10 Oncology, Asan Medical Center, Seoul/KR.9 Thoracic & Esophageal Surgery, Shanghai Chest Hospital, Esophageal Disease Center, 200020 - Shanghai/CN.8 Cancer Institute, CHU Brest – Institut de Cancerologie et d’Hematologie, 29200 - Brest/FR.7 Gastroenterology And Gastrointestinal Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP.6 Experimental Therapeutics, National Cancer Center Hospital East, 277-8577 - Chiba/JP.5 Medical Oncology, IRCM, Inserm, Université Montpellier, ICM, 34090 - Montpellier/FR.4 Medical Oncology, Dana Farber Cancer Institute, 02215 - Boston/US.3 Medical Oncology/solid Tumor Program, Weill Cornell Medical College, New York/US. 2 Medicine, Samsung Medical Center, Sungkyunkwan University, 135-710 - Seoul/KR.1 Gastrointestinal Medical Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP.
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