KEYNOTE-811
KEYNOTE-811 showed that adding the immunotherapy pembrolizumab to trastuzumab and chemotherapy shrank HER2-positive stomach cancers more often and kept them under control for longer, with the gain concentrated in tumours that also express PD-L1.
Overview
KEYNOTE-811 randomised 738 patients with previously untreated HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma to trastuzumab plus fluoropyrimidine and platinum chemotherapy with pembrolizumab or with placebo. The dual primary endpoints were progression-free and overall survival.
At the first interim analysis the pembrolizumab arm had a markedly higher objective response rate, which supported accelerated approval in the United States in May 2021. Later analyses showed longer progression-free survival, with the benefit concentrated in tumours with a PD-L1 combined positive score of 1 or more, and the indication was narrowed to that group in 2023. Overall survival results followed in the same direction in the PD-L1-positive population.
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