非诺莫单抗联合多西他赛与多西他赛治疗晚期鳞状细胞非小细胞肺癌的疗效和安全性：一项随机、双盲、III期试验

IF 3.5 2区医学 Q2 ONCOLOGY

Translational lung cancer research Pub Date : 2025-04-30 Epub Date: 2025-04-16 DOI:10.21037/tlcr-24-1042

Baohui Han, Lin Wu, Runxiang Yang, Hongbo Wu, Wei Li, Yan Yu, Mingjuan Zhang, Hongmei Sun, Tianqing Chu, Fukuan Zhong, Yong Fang, Rong Wu, Tao Bian, Xiaoqing Guo, Meili Sun, Yanming Zhang, Lianke Liu, Xuewen Liu, Yueyin Pan, Ou Jiang, Zonghui Wei, Haifeng Lin, Wei Guo, Jian Fang, Jialei Wang, Cuimin Ding, Yanping Hu, Feng Ye, Wu Zhuang, Shucheng Ye, Lihong Wang, Zhe Huang, Chang Liu, Ling Yang, Jinling Wang, Liangzhi Xie

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引用次数: 0

摘要

背景：肺癌是世界上最常见的癌症，其中非小细胞肺癌（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-1 （PD-1）单克隆抗体（SCT-I10A）加多西他赛治疗晚期鳞状细胞NSCLC （sqNSCLC）患者的疗效和安全性，并与多西他赛进行了比较。方法：将患者按2:1随机分为非诺单抗+多西他赛组（非诺单抗+多西他赛）和多西他赛组（安慰剂+多西他赛），最长6个周期，然后用非诺单抗/安慰剂维持单药治疗。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：188例符合条件的患者入组(非诺莫单抗+多西他赛组：n=126；多西他赛组：n=62)。非诺单抗联合多西他赛组的中位OS （mOS）为17.1个月[95%可信区间（CI）： 11.2, 20.0]，对照组的中位OS （mOS）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)。非诺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）。非诺单抗+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%）。非诺单抗联合多西他赛组DCR为68.3% (95% CI: 59.4%, 76.3%)，对照组DCR为56.5% （95% CI: 43.3%, 69.0%）。非诺单抗+多西他赛组治疗相关不良事件发生率为91.3%(115/126)，对照组为87.1%（54/62）。结论：与多西他赛相比，SCT-I10A联合多西他赛显著延长了接受治疗的晚期sqNSCLC患者的生存期，改善了临床结果，且未增加安全风险。试验注册：NCT04171284， ClinicalTrials.gov。

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Efficacy and safety of finotonlimab plus docetaxel vs. docetaxel in previously treated advanced squamous cell non-small-cell lung cancer: a randomized, double-blinded, phase III trial.

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.

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来源期刊

Translational lung cancer research Medicine-Oncology

CiteScore

7.20

自引率

2.50%

发文量

137

期刊介绍： Translational Lung Cancer Research(TLCR, Transl Lung Cancer Res, Print ISSN 2218-6751; Online ISSN 2226-4477) is an international, peer-reviewed, open-access journal, which was founded in March 2012. TLCR is indexed by PubMed/PubMed Central and the Chemical Abstracts Service (CAS) Databases. It is published quarterly the first year, and published bimonthly since February 2013. It provides practical up-to-date information on prevention, early detection, diagnosis, and treatment of lung cancer. Specific areas of its interest include, but not limited to, multimodality therapy, markers, imaging, tumor biology, pathology, chemoprevention, and technical advances related to lung cancer.