Efficacy and safety of KL-A167 in previously treated recurrent or metastatic nasopharyngeal carcinoma: a multicenter, single-arm, phase 2 study

作者：Yuankai Shi, Xintian Qin, Xingchen Peng, Aiping Zeng, Jingao Li, Chuanben Chen, Sufang Qiu, Suming Pan, Yulong Zheng, Jing Cai, Xiaopin Chen, Shenhong Qu, Lizhu Lin, Jian-Li Huang, Hui Wu, Ying Lu, Wei Wang, Changlu Hu, Xia He, Zhong-Hua Yu, Xiaojian Liu, Bo Xie, Anwen Liu, Guangyuan Hu, Shanghua Jing, Qingyuan Zhang, Renhua Guo, Qi Li, Jinsheng Hong, Feng Jin, Juan Meng, Jianhua Shi, Peiguo Wang, Jiuwei Cui, Kunyu Yang, Xuebang Zhang, Xiaojiang Li, Liangfang Shen, Yuxiang He, Limin Zhai, Xiuhua Sun, Junyou Ge, Yan Qing, Dekang Zong · 发表于：The Lancet Regional Health - Western Pacific · 年份：2022 · DOI：10.1016/j.lanwpc.2022.100617 · 被引用次数：23 · 研究领域：Head and Neck Cancer Studies、Cell Adhesion Molecules Research、Advanced Drug Delivery Systems

Background: KL-A167 is a fully humanized monoclonal antibody targeting programmed cell death-ligand 1. This phase 2 study aimed to evaluate the efficacy and safety of KL-A167 in Chinese patients with previously treated recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC). Methods: This was a multicentre, single-arm, phase 2 study of KL-A167 in R/M NPC (KL167-2-05-CTP) (NCT03848286), conducted at 42 hospitals across the People's Republic of China. Eligible patients had histologically confirmed non-keratinising R/M NPC, and had failed at least two lines of chemotherapy. Patients received KL-A167 900mg intravenously once every 2 weeks until confirmed disease progression, intolerable toxicity, or withdrawal of informed consent. The primary endpoint was objective response rate (ORR) assessed by the independent review committee (IRC) according to RECIST v1.1. Findings: Between Feb 26th, 2019 and Jan 13th, 2021, 153 patients were treated. Totally, 132 patients entered full analysis set (FAS) and were evaluated for the efficacy. As of data cutoff date on Jul 13th, 2021, the median follow-up time was 21.7 months (95%CI 19.8-22.5). For FAS population, the IRC-assessed ORR was 26.5% (95%CI 19.2-34.9%), and disease control rate (DCR) was 56.8% (95%CI 47.9-65.4%). Median progression-free survival (PFS) was 2.8 months (95%CI 1.5-4.1) . Median duration of response was 12.4 months (95%CI 6.8-16.5), and median overall survival (OS) was 16.2 months (95%CI 13.4-21.3). When using the cut...