Study
| Phase 3, open-label, global, randomized trial (CheckMate 9DW) |
| Previously untreated unresectable hepatocellular carcinoma |
| Nivolumab + ipilimumab q3w x4 doses then nivolumab q4w vs. lenvatinib daily or sorafenib BID |
Efficacy
| ORR: 36% vs. 13% (p<0.0001) |
| CR: 7% vs. 2% |
| mDoR: 30.4 mos vs. 12.9 mos |
| mPFS: 9.1 mos vs. 9.2 mos (HR: 0.87 [0.72–1.06]) |
| mOS: 23.7 mos vs. 20.6 mos (HR: 0.79 [0.65–0.96]) |
| 2-yr OS: 49% vs. 39% |
| 3-yr OS: 38% vs. 24% |
Safety
| Grade ≥3 TRAEs: 41% vs. 42% |
| TRAEs leading to discontinuation: 18% vs. 10% |
| Treatment-related deaths: 12 vs. 3 (mostly hepatic causes in immunotherapy arm) |
| Immune-mediated AEs: occurred in 58% (nivolumab + ipilimumab), with 28% grade ≥3, and 29% requiring high-dose corticosteroids |
Lancet 2025;405:1851–64
http://doi.org/10.1016/S0140-6736(25)00403-9
Reviewed by Ulas D. Bayraktar, MD on Jun 2, 2025
