Lenvatinib_pembrolizumab_hcc
Hepatocellular Carcinoma

New Reference: Lenvatinib and Pembrolizumab for HCC

2025-03-02

  • 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

    Kudo M,Ren Z,Guo Y Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study

    http://doi.org/10.1016/S0140-6736(24)02575-3

    Reviewed by Ulas D. Bayraktar, MD on Mar 2, 2025