FDA approves pembrolizumab (PM) combined with trastuzumab (TZ) and chemotherapy as first-line treatment in locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma

Approval is based on ongoing phase 3 KEYNOTE-811 trial, in which PM combined with TZ and either 5-FU plus cisplatin or capecitabine plus oxaliplatin demonstrated statistically significant objective response rate of 74%vs. 52% for those on TZ and chemotherapy alone (p<0.0001).

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