LEAP-002 long-term follow-up: Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma.

作者：Richard S. Finn, Masatoshi Kudo, Philippe Merle, Tim Meyer, Shukui Qin, Masafumi Ikeda, Ruocai Xu, Julien Edeline, Baek‐Yeol Ryoo, Zhenggang Ren, Ann‐Lii Cheng, Peter R. Galle, Shuichi Kaneko, Hiromitsu Kumada, Simcha Pollack, Kalgi Mody, Leonid Dubrovsky, David E. Adelberg, Josep M. Llovet · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.4095 · 被引用次数：6 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cancer Immunotherapy and Biomarkers

4095 Background: LEAP-002 was a randomized, double-blind, phase 3 study (NCT03713593) that was conducted to evaluate the efficacy and safety of first-line lenvatinib plus pembrolizumab versus lenvatinib plus placebo in participants with advanced hepatocellular carcinoma (HCC). The study did not meet its primary end points of OS at final analysis and PFS at interim analysis. After a median study follow-up of 43.6 months, OS, PFS, and ORR remained consistent with the primary efficacy analysis (OS: HR, 0.84 [95% CI, 0.71-0.98]; PFS: HR, 0.81 [95% CI, 0.69-0.95]; ORR, 26.3% vs 17.5%); no new safety signals were observed. Here, we present results based on an additional 15 months of follow-up. Methods: Eligible participants with advanced HCC were randomly assigned 1:1 to receive lenvatinib (8 mg/day if bodyweight [BW] < 60 kg; 12 mg/day if BW ≥60 kg) plus pembrolizumab (200 mg IV Q3W) or lenvatinib plus placebo. Dual primary end points were OS and PFS (per RECIST v1.1 by BICR). Secondary end points included ORR and DOR, both per RECIST v1.1 by BICR, and safety. The database cutoff was September 24, 2024. Results: 794 participants were randomly assigned to receive lenvatinib plus pembrolizumab (n = 395) or lenvatinib plus placebo (n = 399). Median study follow-up was 59.2 mo (range, 52.9-68.3). The HR for OS was 0.80 (95% CI, 0.69-0.94; median, 21.1 months with lenvatinib plus pembrolizumab vs 19.0 months with lenvatinib plus placebo). 60-month OS rates were 19.7% with lenvatinib...