Durvalumab Could Boost Standard of Care for Biliary Tract Cancer

Adding durvalumab to chemotherapy agents gemcitabine and cisplatin improved the overall survival rate by more than 20% among patients with biliary tract cancer, according to the results of the TOPAZ-1 study.

The double-blind, placebo-controlled, phase 3 study randomly assigned patients to receive durvalumab or placebo in combination with gemcitabine plus cisplatin for up to 8 treatment cycles. The primary objective was overall survival. The secondary objectives were determining progression-free survival, response rate, and lack of adverse events.

Of the 685 assigned patients already on chemotherapy, 341 received durvalumab and 344 were given placebo. “The hazard ratio for overall survival was 0.80 (95% CI, 0.66 to 0.97; P=0.021),” the study indicated. The 24-month overall survival rate was higher in the durvalumab group vs the placebo group (24.9% vs 10.4%). Patients given durvalumab showed better response rates than patients given placebo (26.7% vs 18.7%) while the safety profiles for both the treatment groups were similar. The incidences of grade 3 or 4 adverse events were 75.7% and 77.8% with durvalumab and placebo, respectively.

Chemotherapy has been the first-line standard of care for more than 10 years. However, “chemotherapy is associated with a median overall survival of 11.7 months and an estimated 24-month survival rate of approximately 15%,” the authors noted, highlighting the need for newer and better therapies.

“We are hopeful that durvalumab plus gemcitabine and cisplatin will become a new standard of care for advanced biliary tract cancer. Our first task at this time is boosting communication with patients and family members about the potential for this immunotherapy combination and what it may mean for their ongoing care,” the researchers said.

—Priyam Vora

Reference:
Oh D, He A, Qin S, et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. NEJM Evid. 2022; 1(8). DOI: https://doi.org/10.1056/EVIDoa2200015