Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line treatment for unresectable hepatocellular carcinoma (uHCC): First results from CheckMate 9DW.

作者：Peter R. Galle, Thomas Decaens, Masatoshi Kudo, Shukui Qin, Leonardo Fonseca, Bruno Sangro, Hatim Karachiwala, Joong‐Won Park, Edward Gane, Matthias Pinter, David Tai, Armando Santoro, Gonzalo Pizarro, Chang‐Fang Chiu, Michael Schenker, Aiwu Ruth He, Qi Wang, Caitlyn Stromko, Joseph Hreiki, Thomas Yau · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.17_suppl.lba4008 · 被引用次数：151 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cancer Genomics and Diagnostics、Cancer Immunotherapy and Biomarkers

LBA4008 Background: First-line therapies based on programmed death ligand 1 (PD-L1) inhibitors are standard of care (SOC) in uHCC and demonstrate improved outcomes over SOR; however, prognosis remains poor and there is an unmet need for alternative therapies with long-term benefits. Second-line NIVO + IPI demonstrated clinically meaningful efficacy and manageable safety in SOR-treated patients (pts) with HCC in CheckMate 040, leading to its accelerated approval in the United States. We report first results from the preplanned interim analysis of the phase 3, open-label, randomized CheckMate 9DW trial evaluating the efficacy and safety of NIVO + IPI vs LEN or SOR as first-line therapy for pts with uHCC (NCT04039607). Methods: Adult pts with previously untreated HCC not eligible for curative surgical or locoregional therapies, Child-Pugh score 5–6, and ECOG performance status 0–1 were included. Pts were randomly assigned 1:1 to receive NIVO 1 mg/kg + IPI 3 mg/kg Q3W (up to 4 cycles) followed by NIVO 480 mg Q4W or investigator’s choice of LEN 8 mg or 12 mg QD or SOR 400 mg BID until disease progression or unacceptable toxicity. NIVO was given for a maximum of 2 years. The primary endpoint was overall survival (OS). Secondary endpoints included objective response rate (ORR) and duration of response (DOR) per blinded independent central review (BICR) using RECIST v1.1. Results: In total, 668 pts were randomized to NIVO + IPI (n = 335) or LEN/SOR (n = 333); among 325 pts treated in...