Phase 3 trial of pembrolizumab plus chemo for advanced biliary tract carcinoma posts results

A phase 3 randomized controlled trial (KEYNOTE-966) evaluated pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy for advanced and/or unresectable biliary tract carcinoma. The study enrolled 1,069 participants. The primary outcome was overall survival. The lead sponsor, Merck Sharp & Dohme LLC, has posted that results are available, but no specific efficacy data, including hazard ratios, median survival times, or p-values, have been disclosed. No safety or tolerability information on adverse events, serious adverse events, or discontinuation rates has been reported. The key limitation is the absence of publicly reported numerical results from this trial, preventing any assessment of efficacy or safety. The study follow-up duration is also not reported. Until full, peer-reviewed results are published, this trial posting indicates activity in the field but provides no data to inform clinical practice. The practice relevance remains unknown pending detailed analysis of the survival benefit and risk profile.