菲诺妥单抗联合多西他赛用于既往治疗过的晚期鳞状非小细胞肺癌的疗效和安全性：一项随机、双盲、III期试验。
Efficacy and safety of finotonlimab plus docetaxel docetaxel in previously treated advanced squamous cell non-small-cell lung cancer: a randomized, double-blinded, phase III trial.
作者信息
Han Baohui, Wu Lin, Yang Runxiang, Wu Hongbo, Li Wei, Yu Yan, Zhang Mingjuan, Sun Hongmei, Chu Tianqing, Zhong Fukuan, Fang Yong, Wu Rong, Bian Tao, Guo Xiaoqing, Sun Meili, Zhang Yanming, Liu Lianke, Liu Xuewen, Pan Yueyin, Jiang Ou, Wei Zonghui, Lin Haifeng, Guo Wei, Fang Jian, Wang Jialei, Ding Cuimin, Hu Yanping, Ye Feng, Zhuang Wu, Ye Shucheng, Wang Lihong, Huang Zhe, Liu Chang, Yang Ling, Wang Jinling, Xie Liangzhi
机构信息
Respiratory Medicine Department, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Thoracic Medical Oncology, Hunan Cancer Hospital, Changsha, China.
出版信息
Transl Lung Cancer Res. 2025 Apr 30;14(4):1231-1241. doi: 10.21037/tlcr-24-1042. Epub 2025 Apr 16.
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.
背景
肺癌是全球最常见的癌症，非小细胞肺癌（NSCLC）约占80 - 85%。在这项III期试验中，我们评估了抗程序性细胞死亡蛋白1（PD - 1）单克隆抗体（SCT - I10A）联合多西他赛与多西他赛相比，在先前接受过治疗的晚期鳞状细胞非小细胞肺癌（sqNSCLC）患者中的疗效和安全性。
方法
患者按2:1随机分为替雷利珠单抗联合多西他赛组（替雷利珠单抗联合多西他赛）和多西他赛组（安慰剂联合多西他赛），进行最多6个周期的治疗，随后用替雷利珠单抗/安慰剂进行维持单药治疗。主要终点是总生存期（OS）。次要终点包括客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DoR）、无进展生存期（PFS）以及安全性和免疫原性评估。
结果
共纳入188例符合条件的患者（替雷利珠单抗联合多西他赛组：n = 126；多西他赛组：n = 62）。替雷利珠单抗联合多西他赛组的中位OS（mOS）为17.1个月[95%置信区间（CI）：11.2，20.0]，对照组为10.4个月（95% CI：5.9，14.0）。风险比（HR）为0.66（95% CI：0.45，0.96；P = 0.03）。替雷利珠单抗联合多西他赛组和对照组的中位PFS（mPFS）分别为4.2个月（95% CI：3.3，6.9）和2.9个月（95% CI：1.5，3.8）。替雷利珠单抗联合多西他赛组患者的ORR为27.0%（95% CI：19.5%，35.6%），显著高于对照组的3.2%（95% CI：0.4%，11.2%）。替雷利珠单抗联合多西他赛组的DCR为68.3%（95% CI：59.4%，76.3%），对照组为56.5%（95% CI：43.3%，69.0%）。替雷利珠单抗联合多西他赛组91.3%（115/126）的患者发生了治疗相关不良事件（TRAEs），对照组为87.1%（54/62）的患者。
结论
与多西他赛相比，SCT - I10A联合多西他赛显著延长了治疗晚期sqNSCLC患者的OS并改善了临床结局，且未增加安全风险。
试验注册
NCT04171284，ClinicalTrials.gov。
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