Adjuvant pembrolizumab for participants with hepatocellular carcinoma and complete radiologic response after surgical resection or local ablation: The phase 3 keynote-937 study.

作者：Stephen L. Chan, M. Bouattour, Thomas Yau, Ann-Lii Cheng, Yabing Guo, Chuang Peng, Do Young Kim, Lipika Goyal, Long-Bin Jeng, Ming-Chin Yu, Seung Woon Paik, В. В. Бредер, R. Martin, Arndt Vogel, Masatoshi Kudo, Jimin Wu, Usha Malhotra, Abby B. Siegel, J. Llovet, J. Fan · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco.2026.44.2_suppl.477 · 被引用次数：9 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cholangiocarcinoma and Gallbladder Cancer Studies、Cancer Immunotherapy and Biomarkers

477 Background: Tumor recurrence is frequent after surgical resection and local ablation in participants (pts) with hepatocellular carcinoma (HCC). There remains an unmet need for standard-of-care adjuvant therapy to prevent disease recurrence and improve overall survival. The phase 3, randomized, double-blind KEYNOTE-937 (NCT03867084) study evaluated the efficacy and safety of pembrolizumab vs placebo as adjuvant therapy in pts with HCC after surgical resection or local ablation with curative intent. We present results of the third interim (IA3) analysis of KN937. Methods: Eligible pts were aged ≥ 18 years with confirmed HCC, complete response after surgical resection or local ablation, ECOG PS 0 - 1, and Child-Pugh liver class A. Pts with past or ongoing hepatitis C or controlled hepatitis B virus infection could enroll after meeting prespecified criteria. All pts were randomized 1:1 to pembrolizumab 200 mg or placebo IV Q3W until disease recurrence, unacceptable toxicity, intercurrent illness, withdrawal, or up to 17 cycles of pembrolizumab or placebo. Randomization was stratified by geographic region, prior local therapy (resection vs ablation), recurrence risk, and alpha-fetoprotein level at diagnosis. The primary endpoints were recurrence-free survival (RFS) by imaging (BICR) or pathology, and overall survival (OS). Safety was a secondary endpoint. Key exploratory endpoints included distant metastases-free survival (DMFS) and time to recurrence. The data cut-off date wa...