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Pembrolizumab with or without chemotherapy vs chemotherapy for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: The phase III KEYNOTE-062 study

Journal of Clinical Oncology Jun 13, 2019

Tabernero J, et al. - Among pts with PD-L1 combined positive score ≥1 (CPS ≥1), HER2-negative, advanced GC, researchers assessed the impacts of 1L P or P+C vs C in a randomized, active controlled study, KEYNOTE062. Using randomization 1:1:1, they assigned eligible pts to P 200 mg Q3W for up to 2 y, P+C (cisplatin 80 mg/m2 + 5-FU 800 mg/m2/d on d1-d5 Q3W [or capecitabine 1000 mg/m2 BID on d1-d14 Q3W per local guideline]) or placebo Q3W + C. OS in CPS ≥1 and CPS ≥10 for P+C vs C and P vs C and PFS (RECIST v1.1; central review) in CPS ≥1 for P+C vs C were considered as primary endpoints. Findings revealed the non-inferiority of P to C for OS in CPS ≥1 with clinically meaningful improvement for OS in CPS ≥10, when administered as 1L therapy for advanced GC. No superior OS and PFS in CPS ≥1 and OS in CPS ≥10 were demonstrated by P+C. P vs C displayed a more favorable safety profile.
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