CHECKMATE-9DW
Regimen
- Experimental
- nivolumab 1 mg/kg + ipilimumab 3 mg/kg Q3W x4, then nivolumab 480 mg Q4W
- Control
- investigator's choice lenvatinib or sorafenib
Population
Unresectable hepatocellular carcinoma, Child-Pugh A, ECOG 0/1, no prior systemic therapy
Key finding
mOS 23.7 vs 20.6 mo (HR 0.79, 95% CI 0.65-0.96, p=0.018); early hazard crossing — first 6 mo HR 1.65 (worse) then HR 0.61 (better); 24-mo OS 49% vs 39%, 36-mo 38% vs 24%; 12 TRAE deaths vs 3 — **doubled treatment-related mortality** warrants careful patient selection; etiology HBV ~35%, HCV ~26%, non-viral ~39%
Source: PMID 40349714
Timeline
Guideline citations
- NCCN HCC (p.6)