Study
| Phase III, double-blind, randomized, controlled, multicenter, open-label trial (KEYNOTE-966) |
| Previously untreated, unresectable, locally advanced or metastatic biliary tract cancer |
| Pembrolizumab + Gemcitabine + Cisplatin (n=533) vs. Gemcitabine + Cisplatin (n=536) |
Efficacy
| mPFS: 6.5 vs 5.6 mos, p=0.023 |
| 6-mo PFS: 52% vs. 46% |
| 12-mo PFS: 25% vs 20% |
| mOS: 12.7 vs. 10.9 mos , p=0034 |
| 12 months OS: 52% vs.44% |
| 24 months OS: 25% vs.18% |
| mDoR: 9.7 vs 6.9 mos |
Safety
| Grade≥3 AEs: Neutropenia (49% vs 45%), Anemia (29% vs. 29%), fatigue (6% vs. 4%) |
Lancet Oncol, 16 APR, 2023
http://doi.org/10.1016/S0140-6736(23)00727-4
Reviewed by Elvin Chalabiyev, MD on May 20, 2023
