{"entity":{"id":"paper-topaz-1-three-year-survival-j-hepatol-2025","kind":"paper","name":"Durvalumab plus chemotherapy in advanced biliary tract cancer: 3-year overall survival update from the phase III TOPAZ-1 study","aka":[],"tldr":"Three and a half years on, adding durvalumab to chemotherapy for advanced bile duct and gallbladder cancer still showed a survival edge, and about one in seven patients were alive at three years compared with one in fourteen on chemotherapy alone.","summary":"Exploratory update of TOPAZ-1 (685 randomised: 341 durvalumab plus gemcitabine-cisplatin, 344 placebo plus gemcitabine-cisplatin) at a median follow-up of 41.3 months. Median overall survival was 12.9 months (95 percent CI 11.6 to 14.1) against 11.3 months (10.1 to 12.5), hazard ratio 0.74 (0.63 to 0.87); 36-month survival was 14.6 versus 6.9 percent. Among the 82.6 percent who achieved disease control, 36-month survival was 17.0 versus 7.6 percent. Extended long-term survivors (alive at 30 months or more) were 17.0 percent of the durvalumab arm and 8.7 percent of the placebo arm and included every clinically relevant subgroup. Benefit held regardless of subsequent therapy, and serious adverse events in long-term survivors were comparable between arms.","asOf":"2026-09-24","links":[{"label":"J Hepatol 2025","url":"https://doi.org/10.1016/j.jhep.2025.05.003"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/40381735/"},{"label":"ClinicalTrials.gov NCT03875235","url":"https://clinicaltrials.gov/study/NCT03875235"}],"tags":["gallbladder-evidence"],"related":["paper-topaz-1-nejm-evidence-2022","gemcis-plus-io-btc"],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["durvalumab","gemcitabine-cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["os"],"trials":["topaz-1"],"people":["juan-valle"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"Journal of Hepatology","year":2025,"doi":"10.1016/j.jhep.2025.05.003","pmid":"40381735","authors":"Oh DY, He AR, Qin S, et al.","paperType":"rct","findings":["Median overall survival 12.9 vs 11.3 months; hazard ratio 0.74 (95 percent CI 0.63 to 0.87) at 41.3 months median follow-up.","36-month overall survival 14.6 vs 6.9 percent.","Extended long-term survivors 17.0 vs 8.7 percent."],"whatItMeans":"The tail of long survivors is the case for chemo-immunotherapy in gallbladder cancer, where the median gain is under two months. Who lands in that tail is still unknown; no biomarker in the trial predicts it.","caveats":["Exploratory, post hoc analysis.","Gallbladder cancer is a subgroup of a mixed biliary population."],"changedPractice":false,"participants":685},"route":"/key-papers/paper-topaz-1-three-year-survival-j-hepatol-2025/","neighbours":{"paper":[{"id":"paper-topaz-1-nejm-evidence-2022","kind":"paper","name":"TOPAZ-1: durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer","route":"/key-papers/paper-topaz-1-nejm-evidence-2022/"}],"pairing":[{"id":"gemcis-plus-io-btc","kind":"pairing","name":"Gemcitabine-cisplatin + PD-(L)1 blockade in biliary cancer","route":"/pairings/gemcis-plus-io-btc/"}],"cancer":[{"id":"biliary-tract-cancer","kind":"cancer","name":"Biliary tract cancer (all types)","route":"/cancers/biliary-tract-cancer/"},{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"}],"drug":[{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"gemcitabine-cisplatin","kind":"drug","name":"Gemcitabine + cisplatin","route":"/drugs/gemcitabine-cisplatin/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"term":[{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"}],"trial":[{"id":"topaz-1","kind":"trial","name":"TOPAZ-1","route":"/trials/topaz-1/"}],"person":[{"id":"juan-valle","kind":"person","name":"Juan W. Valle","route":"/people/juan-valle/"}],"roadmap":[{"id":"gallbladder-cancer-roadmap","kind":"roadmap","name":"Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials","route":"/roadmaps/gallbladder-cancer-roadmap/"}]}}