Pembrolizumab in Chinese patients with advanced melanoma: 3-year follow-up of the KEYNOTE-151 study

作者：Lu Si, Xiaoshi Zhang, Yongqian Shu, Hongming Pan, Di Wu, Jiwei Liu, Lili Mao, Xuan Wang, Xizhi Wen, Yanhong Gu, Lingjun Zhu, Shijie Lan, Xin Cai, Scott J. Diede, Haiyan Dai, Cuizhen Niu, Jianfeng Li, Jun Guo · 发表于：Frontiers in Immunology · 年份：2022 · DOI：10.3389/fimmu.2022.882471 · 被引用次数：29 · 研究领域：Cutaneous Melanoma Detection and Management、Cancer Immunotherapy and Biomarkers、CAR-T cell therapy research

Survival is generally poor for Chinese patients with advanced melanoma because of high rates of acral and mucosal melanoma and limited therapeutic options. The first analysis of the phase 1b KEYNOTE-151 study showed second-line pembrolizumab was well tolerated and had clinically meaningful antitumor activity in Chinese patients with advanced melanoma. Three-year follow-up is presented. Eligible patients were of Chinese descent and had unresectable stage III/IV melanoma that progressed after first-line therapy. Patients received pembrolizumab 2 mg/kg every 3 weeks for ≤35 cycles. Primary end points were safety and objective response rate (ORR). Secondary end points included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Response was assessed per RECIST v1.1 by blinded independent central review. Subgroup analyses were conducted by melanoma subtype and BRAF and PD-L1 status (acral melanoma only). 103 patients were enrolled; median follow-up duration (time from first dose to data cutoff [July 13, 2020]) was 44.6 months (IQR, 39.1–46.2). Any-grade treatment-related adverse events (TRAEs) occurred in 85.4% of patients, and grade 3/4 TRAEs in 12.6%. No grade 5 TRAEs occurred. Three patients discontinued pembrolizumab because of TRAEs (immune-mediated hepatitis, pneumonia, and arthritis). Immune-mediated AEs and infusion reactions occurred in 34.0% (grade 3/4, 2.9%). ORR was 17.6% (95% CI, 10.8–26.4; 1 complete response/17 partial responses),...