LEAP-002 — Pembrolizumab Plus Lenvatinib Versus Lenvatinib in First-Line Advanced Hepatocellular Carcinoma (LEAP-002)

Phase 3 · 2023 · Hepatocellular Carcinoma

Design

Randomized, double-blind trial of lenvatinib plus pembrolizumab vs lenvatinib plus placebo in first-line unresectable HCC.

Population

Untreated unresectable hepatocellular carcinoma, Child-Pugh A, BCLC stage B or C.

Primary Endpoint

overall survival (OS) and progression-free survival (PFS)

Key Result

Median OS 21.2 vs 19.0 mo (HR 0.84) — numerically improved but did not meet the prespecified significance threshold.

Guideline Impact

Did not change practice; informs first-line HCC regimen selection