Efficacy and safety of finotonlimab plus docetaxel

• Tác giả: Tao Bian, Tianqing Chu, Cuimin Ding, Jian Fang, Yong Fang, Wei Guo, Xiaoqing Guo, Baohui Han, Yanping Hu, Zhe Huang, Ou Jiang, Wei Li, Haifeng Lin, Chang Liu, Lianke Liu, Xuewen Liu, Yueyin Pan, Hongmei Sun, Meili Sun, Jialei Wang, Jinling Wang, Lihong Wang, Zonghui Wei, Hongbo Wu, Lin Wu, Rong Wu, Liangzhi Xie, Ling Yang, Runxiang Yang, Feng Ye, Shucheng Ye, Yan Yu, Mingjuan Zhang, Yanming Zhang, Fukuan Zhong, Wu Zhuang
• Ngôn ngữ: eng
• Ký hiệu phân loại: 583.625 *Violates
• Thông tin xuất bản: China : Translational lung cancer research , 2025
• Bộ sưu tập: NCBI
• ID: 749121

Tóm tắt

 BACKGROUND: Lung cancer is the most common cancer in the world, and non-small cell lung cancer (NSCLC) constitutes about 80-85%. In this phase III trial, we evaluate the efficacy and safety of anti-programmed cell death-1 (PD-1) monoclonal antibody (SCT-I10A) plus docetaxel compared to docetaxel in patients with previously treated advanced squamous cell NSCLC (sqNSCLC). METHODS: Patients were randomized 2:1 to finotonlimab plus docetaxel group (finotonlimab plus docetaxel) and docetaxel group (placebo plus docetaxel) for up to 6 cycles, followed by maintenance monotherapy with finotonlimab/placebo. The primary endpoint was overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS) as well as assessments of safety and immunogenicity. RESULTS: There were 188 eligible patients enrolled (finotonlimab plus docetaxel group: n=126
  docetaxel group: n=62). Median OS (mOS) was 17.1 months [95% confidence interval (CI): 11.2, 20.0] in the finotonlimab plus docetaxel group and 10.4 months (95% CI: 5.9, 14.0) in the control group. Hazard ratio (HR) was 0.66 (95% CI: 0.45, 0.96
  P=0.03). Median PFS (mPFS) was 4.2 months (95% CI: 3.3, 6.9) and 2.9 months (95% CI: 1.5, 3.8) respectively in the finotonlimab plus docetaxel group and control group. Patients in the finotonlimab plus docetaxel group achieved an ORR of 27.0% (95% CI: 19.5%, 35.6%), which was significantly higher than the 3.2% (95% CI: 0.4%, 11.2%) in the control group. The DCR was 68.3% (95% CI: 59.4%, 76.3%) in the finotonlimab plus docetaxel group and 56.5% (95% CI: 43.3%, 69.0%) in the control group. Treatment-related adverse events (TRAEs) occurred in 91.3% (115/126) patients of finotonlimab plus docetaxel group and 87.1% (54/62) patients of control group. CONCLUSIONS: SCT-I10A combined with docetaxel significantly prolonged OS and improved clinical outcomes in patients with treated advanced sqNSCLC compared to docetaxel, without increasing safety risk. TRIAL REGISTRATION: NCT04171284, ClinicalTrials.gov.