Four years out, durvalumab + chemo still delivering for biliary tract cancer. A post hoc analysis of the phase 3 TOPAZ-1 trial found that adding durvalumab to standard gemcitabine-cisplatin chemotherapy nearly tripled the 48-month survival rate in advanced biliary tract cancer — 11.8% vs. 4.3% — with no new safety concerns emerging after four years of follow-up.
Four years later, durvalumab's survival benefit holds strong
The phase 3 TOPAZ-1 trial already showed that adding durvalumab (an immunotherapy) to standard gemcitabine-cisplatin (GemCis) chemotherapy improved survival in advanced biliary tract cancer. Now, a new post hoc analysis — the longest follow-up of any immunotherapy-chemo combo in this setting — confirms that benefit is durable. At 48 months, patients on durvalumab + GemCis had a survival rate of 11.8% vs. just 4.3% for those on placebo + GemCis.
The trial enrolled 685 patients with unresectable, locally advanced, or metastatic biliary tract cancer across 105 sites in 17 countries. Patients received durvalumab or placebo alongside chemotherapy for up to eight cycles, followed by maintenance monotherapy. Median overall survival was 13.0 months in the durvalumab arm vs. 11.4 months in the placebo arm (HR: 0.75).
By the Numbers
Why it matters: Biliary tract cancers are aggressive and hard to treat, with few long-term survivors. This 4-year data reinforces durvalumab + GemCis as a viable first-line standard of care, offering a meaningful — if modest — chance at long-term survival with an acceptable safety profile.
