{"entity":{"id":"paper-keynote-966-lancet-2023","kind":"paper","name":"KEYNOTE-966: pembrolizumab plus gemcitabine and cisplatin for advanced biliary tract cancer","aka":[],"tldr":"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.","summary":"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.\n\nMedian overall survival was 12.7 versus 10.9 months (hazard ratio 0.83), with a consistent effect across subgroups and no new safety signals.","asOf":"2026-09-17","links":[{"label":"Lancet 2023","url":"https://doi.org/10.1016/S0140-6736(23)00727-4"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37075781/"}],"tags":[],"related":[],"cancers":["intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["cisplatin","gemcitabine","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["keynote-966"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["lancet"],"dependsOn":[],"notes":[],"journal":"The Lancet","year":2023,"doi":"10.1016/S0140-6736(23)00727-4","pmid":"37075781","authors":"Kelley RK, Ueno M, Yoo C, et al.","paperType":"rct","findings":["Median overall survival 12.7 vs 10.9 months; hazard ratio 0.83.","Median progression-free survival 6.5 vs 5.6 months."],"whatItMeans":"Pembrolizumab with gemcitabine-cisplatin is an approved first-line option for advanced biliary tract cancer alongside durvalumab-based therapy.","caveats":["Modest absolute gain; no biomarker enrichment."],"changedPractice":true,"participants":1069},"route":"/key-papers/paper-keynote-966-lancet-2023/","neighbours":{"cancer":[{"id":"intrahepatic-cholangiocarcinoma","kind":"cancer","name":"Intrahepatic cholangiocarcinoma","route":"/cancers/intrahepatic-cholangiocarcinoma/"}],"drug":[{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"trial":[{"id":"keynote-966","kind":"trial","name":"KEYNOTE-966","route":"/trials/keynote-966/"}],"journal":[{"id":"lancet","kind":"journal","name":"The Lancet","route":"/journals/lancet/"}]}}