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In a prior single-arm, phase II study (KEYNOTE-059), the immune checkpoint inhibitor pembrolizumab demonstrated a modest signal of activity in advanced chemotherapy-refractory gastric or gastroesophageal junction adenocarcinoma (NEJM JW Oncol Hematol Jun 2018 and JAMA Oncol 2018; 4:e180013).
Investigators now report the results of an industry-sponsored, international, open-label, randomized, controlled phase III trial (KEYNOTE-061) of pembrolizumab versus paclitaxel chemotherapy in 395 patients (median age, 61–65 years) with metastatic esophagogastric adenocarcinoma who progressed on treatment with fluorinated pyrimidine platinum therapy and had PD-L1–positive scores of ≥1. Most patients had gastric primaries (63%–68%) and had not undergone …