Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)

Phase 3 Completed 794 enrolled Merck Sharp & Dohme LLC Eisai Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).

Timeline

Start: 2018-12-31
Primary completion: 2022-06-21
Completion: 2024-09-24

Outcome

Missed primary endpoint

paper lenvatinib plus pembrolizumab did not meet prespecified significance for improved overall survival and progression-free survival versus lenvatinib plus placebo. PMID 38039993 ↗

release “臨床第Ⅲ相試験（LEAP-002試験）において、全生存期間（Overall Survival: OS）と無増悪生存期間（Progression-Free Survival: PFS）の二つの主要評価項目を達成できなかった” msd.co.jp ↗

Publications

Results Llovet JM, Kudo M, Merle P, Meyer T, Qin S, Ikeda M, Xu R, Edeline J, Ryoo BY, Ren Z, Masi G, Kwiatkowski M, Lim HY, Kim JH, Breder V, Kumada H, Cheng AL, Galle PR, Kaneko S, Wang A, Mody K, Dutcus C, Dubrovsky L, Siegel AB, Finn RS; LEAP-002 Investigators. Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma (LEAP-002): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Dec;24(12):1399-1410. doi: 10.1016/S1470-2045(23)00469-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenvatinib	Small molecule	8 mg	Oral
Subject	Lenvatinib	Small molecule	12 mg	Oral
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous