Study
Multicenter, randomised, double-blind, phase 3 study (LEAP-012) |
Unresectable, non-metastatic hepatocellular carcinoma |
TACE + lenvatinib + pembrolizumab (n=237) vs TACE + placebo (n=243) |
Efficacy
mPFS: 14.6 mos vs. 10.0 mos (TACE + lenvatinib + pembrolizumab vs. TACE + placebo) (HR: 0.66 [0.51-0.84]) |
24-mo OS: 75% vs. 69% (HR: 0.80 [0.57-1.11]) |
Safety
Grade ≥3 AEs: hypertension (24% vs. 7%), platelet count decreased (11% vs. 6%) |
Treatment-related deaths: 2% vs. 1% |
Lancet 2025;405:203-15
http://doi.org/10.1016/S0140-6736(24)02575-3
Reviewed by Ulas D. Bayraktar, MD on Mar 2, 2025