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Standard treatment of advanced HER2-positive esophagogastric cancer combines trastuzumab with fluorinated pyrimidine/platinum-based chemotherapy. Investigators now report a planned interim analysis of response rates in the industry-sponsored, international, phase 3 KEYNOTE-811 trial in which patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma were randomized to treatment with either pembrolizumab (200 mg every 3 weeks) or placebo along with trastuzumab and investigator's choice of capecitabine/oxaliplatin or infusional 5-FU/cisplatin.
Of 433 patients randomized, 81% were male, 68% had gastric primary tumors, 81% were immunohistochemistry positive at 3+ for HER2, and 84% were PD-L1–positive at ≥1%. In this interim …