LEAP-002

NCT03713593 📎

Regimen

Experimental
lenvatinib + pembrolizumab
Control
lenvatinib + placebo

Population

Unresectable hepatocellular carcinoma, Child-Pugh A, no prior systemic therapy

Key finding

mOS 21.2 vs 19.0 mo (HR 0.84, 95% CI 0.71-1.00, p=0.023 — but prespecified threshold was p≤0.019); mPFS 8.2 vs 8.0 mo (HR 0.87, p=0.047 — threshold p≤0.002); **both primary endpoints failed** despite numerical benefit; etiology: HBV 47%, HCV 20%, non-viral 33%

Source: PMID 38039993

Timeline

    Guideline citations

    • NCCN HCC (p.73)