Durvalumab Plus GemCis Delivers Sustained Survival Benefit in Advanced

The 3-year update from the phase III TOPAZ-1 trial shows that durvalumab combined with gemcitabine and cisplatin (GemCis) significantly improved overall survival in advanced biliary tract cancer compared to placebo+GemCis, with a median OS of 12.9 versus 11.3 months and a 36-month OS rate of 14.6% versus 6.9%. Notably, extended long-term survivors (alive ≥30 months) were nearly doubled in the durvalumab arm (17.0% vs. 8.7%), and the survival benefit persisted regardless of subsequent anticancer therapy, all while maintaining a manageable safety profile.

These findings reinforce the durability of the survival benefit and endorse durvalumab+GemCis as the standard first-line treatment for patients with advanced biliary tract cancer.