Pembrolizumab plus gemcitabine and cisplatin for advanced biliary tract cancer: longer-term follow-up from the randomised, double-blind, placebo-controlled, phase 3 KEYNOTE-966 trial

Summary: Background: At the final analysis of KEYNOTE-966 (median follow-up 25·6 months), pembrolizumab plus gemcitabine and cisplatin (pembrolizumab group) versus placebo plus gemcitabine and cisplatin (placebo group) provided a statistically significant, clinically meaningful improvement in overall survival without any new safety signals in participants with advanced biliary tract cancer. We report results from a median study follow-up of 36·6 months (∼3 years).