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Studies of the anti–PD-1 immune checkpoint inhibitor pembrolizumab in patients with gastric cancer have had mixed results. Investigators now report findings from KEYNOTE-859, an industry-sponsored, placebo-controlled, double-blind, randomized phase 3 trial. The 1579 participants with HER2-negative, metastatic gastric or gastroesophageal junction (GEJ) cancer received pembrolizumab or placebo plus first-line chemotherapy (either infusional 5-FU combined with cisplatin or capecitabine combined with oxaliplatin) on a 3-week schedule.
Of the participants, 78% had a combined positive score (CPS) for PD-L1 of ≥1%, and 35% had CPS scores ≥10%. Most patients (79%) had gastric primaries, 78% had not undergone prior surgery, and 39% had hepatic metast…