Approval was based on the prespecified interim analysis of the first 264 patients of the ongoing KEYNOTE-811 trial, a multicenter, randomized, double‑blind, placebo‑controlled trial in patients with HER2‑positive advanced gastric or gastroesophageal junction adenocarcinoma who had not previously received systemic therapy for metastatic disease. Patients were randomized (1:1) to receive pembrolizumab 200 mg or placebo every 3 weeks, in combination with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin. The main efficacy measure for this analysis was ORR assessed by blinded independent review committee. The ORR was 74% in Keytruda arm and 52% in the placebo arm. The adverse reaction profile observed in patients receiving pembrolizumab in Study KEYNOTE-811 is consistent with the known Keytruda safety profile. The recommended Keytruda dose for adult patients with locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma in combination with trastuzumab and chemotherapy is 200 mg every 3 weeks or 400 mg every 6 weeks.