KEYNOTE-966: pembrolizumab plus gemcitabine and cisplatin for advanced biliary tract cancer
Adding pembrolizumab to gemcitabine-cisplatin, with gemcitabine continued as maintenance, lengthened survival in advanced biliary tract cancer by about two months, confirming the role of chemo-immunotherapy shown by TOPAZ-1.
Overview
Phase 3 placebo-controlled trial of 1,069 patients with untreated metastatic or unresectable biliary tract cancer randomised to pembrolizumab or placebo with gemcitabine-cisplatin, with gemcitabine continued beyond eight cycles.
Median overall survival was 12.7 versus 10.9 months (hazard ratio 0.83), with a consistent effect across subgroups and no new safety signals.
- Median overall survival 12.7 vs 10.9 months; hazard ratio 0.83.
- Median progression-free survival 6.5 vs 5.6 months.
Pembrolizumab with gemcitabine-cisplatin is an approved first-line option for advanced biliary tract cancer alongside durvalumab-based therapy.
- Modest absolute gain; no biomarker enrichment.
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