Article
作者: Han, Ping ; Li, Guoqing ; Jiang, Hao ; Shi, Yuankai ; Liu, Yanyan ; Zheng, Yulong ; Peng, Liang ; Zhang, Shurong ; Gui, Lin ; Cui, Jiuwei ; Wu, Yunteng ; Huang, Xiaoming ; Zhou, Xiaohong ; Ding, Yuhai ; Guo, Wei ; Wu, Yunong ; Jia, Xiaojing ; Cai, Qingqing ; Jing, Shanghua ; Chen, Xiaopin ; Xie, Liangzhi ; Xiong, Deming ; Wang, Yan ; Chang, Zhiwei ; Gai, Wenlin ; Wang, Lin ; Peng, Hanwei ; Fang, Meiyu ; Hu, Guangyuan ; Qu, Song ; Hu, Chunhong ; Shi, Jianhua ; Wang, Wei ; Wu, Hui ; Bai, Yuansong ; Zhai, Limin ; Wu, Rong ; Cui, Wei ; Zhang, Songnan ; Dong, Pin ; Zhang, Qingyuan ; Su, Yuehua ; Cao, Junning ; Sun, Yan ; Li, Xiaojiang ; Fu, Zhichao
Immunotherapy combined with chemotherapy regimen has been shown to be effective in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). However, due to the small number of patients, its efficacy remains controversial in Asian populations, particularly in mainland China. Here a randomized, double-blind phase 3 trial evaluated the efficacy and safety of finotonlimab (SCT-I10A), a programmed cell death 1 (PD-1) monoclonal antibody, combined with cisplatin plus 5-fluorouracil (C5F) for the first-line treatment of R/M HNSCC. Eligible patients (n = 370) were randomly 2:1 assigned to receive finotonlimab plus C5F (n = 247) or placebo plus C5F (n = 123). The primary endpoint was overall survival (OS). In the finotonlimab plus C5F group, OS was 14.1 months (95% confidence interval (CI) 11.1-16.4), compared with 10.5 months (95% CI 8.1-11.8) in the placebo plus C5F group. The hazard ratio was 0.73 (95% CI 0.57-0.95, P = 0.0165), meeting the predefined superiority criteria for the primary endpoint. Finotonlimab plus C5F showed significant OS superiority compared with C5F alone and acceptable safety profile with R/M HNSCC, supporting its use as a first-line treatment option for R/M HNSCC. These results validate the efficacy and safety of the combination of finotonlimab and C5F in Asian patients with R/M HNSCC. ClinicalTrials.gov identifier: NCT04146402 .