Study
| Double-blind, placebo-controlled, phase 3 study |
| Untreated unresectable or metastatic biliary tract cancer |
| Gemcitabine – cisplatin plus Durvalumab (341) or placebo (344) |
Efficacy
| 24 month OS: 24.9% vs. 10.4% |
| ORR: 26.7% vs. 18.7% |
| mPFS: 7.2 mos vs. 5.7 mos (HR:0.75, P=0.001) |
| DOR: 7.3 mos vs. 5.8 mos |
Safety
| Any grade AEs: 99.4% vs 98.8%, anemia:48.2%-44.7%, nausea: 40.2%-34.2, neutropenia:31.7%-31% |
| Grade ≥3 AEs: 75.7% vs 77.8% |
| Deaths due to adverse events: 3.6% vs 4.1% |
| Immune-mediated AEs: 12.7% – 4.7% |
NEJM Evid 2022; 1 (8)
{“Do-Youn Oh et al.”}Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer
http://doi.org/10.1056/EVIDoa2200015
Reviewed by Hasan Cagri Yildirim, MD on Nov 26, 2022
