Immunotherapy in biliary tract cancer: are we finally on the right path?
Mené dans 17 pays sur 685 patients atteints d'un cancer des voies biliaires de stade avancé (durée médiane de suivi : 23,4 mois), cet essai randomisé de phase III évalue l'efficacité, du point de vue de la survie globale, et la toxicité de l'ajout du durvalumab à une chimiothérapie combinant gemcitabine et cisplatine
In The Lancet Gastroenterology & Hepatology, Do-Youn Oh and colleagues 1 report the updated analysis of the pivotal TOPAZ-1 study, a phase 3, global, randomised trial assessing the role of the anti-PD-L1 durvalumab plus chemotherapy as first-line treatment compared with chemotherapy alone in patients with biliary tract cancer. The experimental group showed a statistically significant benefit in overall survival at the preplanned interim analysis of TOPAZ-1, which was published in 2022, with a hazard ratio (HR) of 0·80 (95% CI 0·66–0·97; p=0·021) and an estimated 24-month overall survival rate of 24·9% (95% CI 17·9–32·5) for durvalumab and 10·4% (4·7–18·8) for placebo. 2 Furthermore, the addition of durvalumab to gemcitabine–cisplatin improved progression-free survival (7·2 months vs 5·7 months) and overall response rate (26·7% vs 18·7%) compared with placebo plus gemcitabine–cisplatin. Considering these results, the US Food and Drug Administration and European Medical Agency approved durvalumab in combination with chemotherapy for patients with advanced biliary tract cancer as the new gold-standard first-line treatment.