Durvalumab plus chemotherapy enhances 3-year survival in advanced biliary tract cancer

Prof. Do-Youn Oh (Seoul National University, Korea) presented updated findings from the phase 3 TOPAZ-1 trial, revealing that durvalumab combined with standard-of-care (SOC) chemotherapy significantly improved 3-year overall survival (OS) compared with chemotherapy alone in patients with advanced biliary tract cancer.

TOPAZ-1 (NCT03875235) randomised participants to receive 1,500 mg of durvalumab (n=341) or placebo (n=344) on day 1 of each 21-day cycle, alongside gemcitabine and cisplatin for up to 8 cycles. This was followed by durvalumab or placebo monotherapy every 4 weeks until disease progression or unacceptable toxicity. The primary endpoint was OS, with secondary endpoints including progression-free survival, objective response rate, and safety.

With a median follow-up of 41.3 months, the combination of durvalumab and chemotherapy reduced the risk of death by 26% compared with chemotherapy alone (HR 0.74; 95% CI 0.63–0.87), and this was an improvement over the primary analysis (HR 0.80, 95% CI 0.66–0.97). Participants receiving the combination treatment had a median OS of 12.9 months, versus 11.3 months for those on chemotherapy plus placebo. The 3-year OS rate was 14.6% in the combination arm and 6.9% in the placebo arm.

The combination regimen was generally well-tolerated, with no new safety concerns. Serious treatment-related adverse events occurred in 15.4% of the participants in the combination arm and in 17.3% of those in the placebo arm.

This analysis represents the longest survival follow-up in a global phase 3 immunotherapy trial for advanced biliary tract cancer. Long-term survival benefit was not driven by any particular subgroup of participants.

“The latest data from TOPAZ-1 shows that twice as many patients with advanced biliary tract cancer were still alive at 3 years with durvalumab and chemotherapy, which is a significant advance given the historically poor prognosis in this setting,” concluded Prof. Oh.

1. Oh DY, et al. Three-year survival, safety and extended long-term survivor (eLTS) analysis from the Phase 3 TOPAZ-1 study of durvalumab (D) plus chemotherapy in biliary tract cancer (BTC). Abstract 279MO; ESMO GI, 26-29 June 2024. Munich, Germany.

Medical writing support was provided by Dr Rachel Giles.
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Posted on 2 July 20242 July 2024