CHECKMATE-459
Regimen
- Experimental
- nivolumab 240 mg Q2W
- Control
- sorafenib
Population
Advanced hepatocellular carcinoma, no prior systemic therapy, Child-Pugh A, ECOG 0/1, regardless of viral hepatitis status
Key finding
mOS 16.4 vs 14.7 mo (HR 0.85, 95% CI 0.72-1.02, p=0.075) — **did NOT meet prespecified threshold p=0.0419**; numerical benefit but statistically negative; triggered July 2021 FDA accelerated approval withdrawal for 2L nivo mono in HCC
Source: PMID 34914889