KEYNOTE-062: pembrolizumab or pembrolizumab plus chemotherapy versus chemotherapy in PD-L1-positive advanced gastric cancer
In first-line PD-L1-positive gastric cancer, pembrolizumab alone was no worse than chemotherapy for survival but did not beat it, and adding it to chemotherapy did not help either; the exception was microsatellite-unstable tumours, which did dramatically better with pembrolizumab.
Overview
Phase 3 trial of 763 patients with untreated advanced gastric or junctional adenocarcinoma with PD-L1 combined positive score of 1 or more randomised to pembrolizumab, pembrolizumab plus chemotherapy, or chemotherapy.
Pembrolizumab was non-inferior to chemotherapy for overall survival (10.6 versus 11.1 months) and combination therapy was not superior; in the 50 patients with microsatellite instability-high tumours, median overall survival was not reached with pembrolizumab against 8.5 months with chemotherapy.
- Pembrolizumab non-inferior to chemotherapy overall (10.6 vs 11.1 months).
- Microsatellite instability-high: overall survival not reached vs 8.5 months with chemotherapy.
Single-agent pembrolizumab is an option for microsatellite-unstable gastric cancer first line, whereas for the broader PD-L1-positive population chemo-immunotherapy from CheckMate 649 and KEYNOTE-859 became standard.
- Microsatellite-unstable subgroup was small and exploratory.
- Early progression was more frequent with pembrolizumab alone.
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