The updated results from the Phase III TOPAZ-1 trial, with a median follow-up of about 41 months, provide the longest data yet for durvalumab combined with gemcitabine and cisplatin in advanced biliary tract cancer. The study continues to show a strong and lasting survival benefit for patients receiving the immunotherapy combination compared to standard chemotherapy alone.
Median overall survival reached 12.9 months with durvalumab versus 11.3 months with placebo. At three years, 14.6% of patients in the durvalumab group were still alive—more than double the 6.9% seen with placebo. The hazard ratio for survival improved to 0.74 (95% CI, 0.63–0.87), highlighting a sustained treatment effect over time.
More patients in the durvalumab group achieved long-term survival beyond 30 months (17% vs. 8.7%), with benefits seen even in those whose disease was stable rather than shrinking. The survival advantage persisted whether or not patients went on to receive further anticancer therapy, and the time before starting another treatment was longer in the durvalumab group (18.7 vs. 12.3 months).
The combination’s safety remained stable and manageable, with no new side effects reported and similar rates of serious adverse events between the two groups. Overall, these long-term findings strengthen the evidence that durvalumab plus gemcitabine and cisplatin offers durable, clinically meaningful benefits and should remain the standard first-line treatment for advanced biliary tract cancer.