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Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial

Publicado por
Rha, SY, Oh, DY, Yañez, P, Bai, Y, Ryu, MH, Lee, J, Rivera, F, Alves, GV, Garrido, M, Shiu, KK, Fernández, MG, Li, J, Lowery, MA, Çil, T, Cruz, FM, Qin, S, Luo, S, Pan, H, Wainberg, ZA, Yin, L, Bordia, S, Bhagia, P, Wyrwicz, LS, KEYNOTE-859 investigators, Castro-Oliden, V

Publicado 2023

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Background: PD-1 inhibitors combined with chemotherapy have shown efficacy in gastric or gastro-esophageal junction cancer. We compared the efficacy and safety of pembrolizumab plus chemotherapy with placebo plus chemotherapy in participants with locally advanced or metastatic HER2-negative gastric or gastro-esophageal junction adenocarcinoma. Methods: KEYNOTE-859 is a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial, done at 207 medical centres across 33 countries. Eligible participants were aged 18 years and older with previously untreated histologically or cytologically confirmed locally advanced or metastatic HER2-negative gastric or gastro-esophageal junction adenocarcinoma and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (1:1) to receive pembrolizumab or placebo 200 mg, administered intravenously every 3...