KEYNOTE-859: pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer
Adding pembrolizumab to platinum-fluoropyrimidine chemotherapy lengthened survival in HER2-negative advanced gastric cancer, with the largest gain in tumours with a PD-L1 combined positive score of 10 or more, confirming chemo-immunotherapy as first-line standard.
Overview
Phase 3 placebo-controlled trial of 1,579 patients with untreated HER2-negative locally advanced or metastatic gastric or junctional adenocarcinoma randomised to pembrolizumab or placebo with fluoropyrimidine-platinum chemotherapy.
Median overall survival was 12.9 versus 11.5 months overall (hazard ratio 0.78), 13.0 versus 11.4 months in combined positive score 1 or more (hazard ratio 0.74) and 15.7 versus 11.8 months in score 10 or more (hazard ratio 0.65).
- Median overall survival 12.9 vs 11.5 months overall; hazard ratio 0.78.
- Combined positive score 10 or more: 15.7 vs 11.8 months; hazard ratio 0.65.
Pembrolizumab plus chemotherapy is approved for HER2-negative advanced gastric cancer, alongside nivolumab plus chemotherapy from CheckMate 649, with strongest evidence at higher PD-L1 scores.
- Benefit in PD-L1-low tumours is small, and European approval is restricted to combined positive score 1 or more.
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