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在可切除非小细胞肺癌中使用或不使用relatlimab的新辅助尼沃卢马布:一个随机的第二阶段试验

Martin Schuler^1,2,3, Kristof Cuppens^4,5, Till Plönes^6,7,8

¹West German Cancer Center, Department of Medical Oncology, University Hospital Essen, Essen, Germany. martin.schuler@uk-essen.de.

Nature medicine

|April 30, 2024

概括

单独使用尼沃卢马布 (抗PD-1) 或与relatlimab (抗LAG-3) 结合的手术前免疫疗法对于可切除的非小细胞肺癌是可行的和安全的. 这两种组合都显示出有希望的生存率和病理反应,支持它们在早期肺癌治疗中的潜力.

科学领域:

免疫治疗是一种免疫疗法.
在瘤学瘤学.
手术瘤学手术瘤学

背景情况:

针对PD-1,PD-L1和CTLA-4的免疫检查点抑制剂是转移性非小细胞肺癌 (NSCLC) 的标准.
在NSCLC中进行手术前免疫治疗已经显示出有前途的瘤反应和改善无事件生存率.
新型抗体组合可能会提高早期NSCLC的疗效和耐受性.

研究的目的:

评估新辅助药尼沃卢马布 (抗PD-1) 与或没有relatlimab (抗LAG-3) 的可行性和安全性,用于治疗未经治疗的可切除NSCLC患者.
评估病理和放射性反应率,手术结果和生存数据.
探索双重PD-1和LAG-3阻断在瘤微环境中的生物效应.

主要方法:

一项正在进行的,开放的,随机的第二阶段研究,涉及60名生物标志物未被选择的,未经治疗的患有可切除NSCLC的患者.
患者接受了两次单独或与relatlimab.com结合的nivolumab手术前剂量.
主要终点:在43天内进行手术的可行性. 二级终点:病理/放射性反应,生存率和安全性.

主要成果:

对所有患者来说,手术在43天内是可行的,在95%的患者中实现了治愈切除.
在27% (nivolumab) 和30% (nivolumab + relatlimab) 的患者中观察到主要的病理反应.
十二个月无病和整体存活率很高:89%/93% (尼沃卢马布) 和93%/100% (尼沃卢马布+relatlimab).
治疗出现的≥3级不良事件很少 (10%和13%).

结论:

在手术前对PD-1和LAG-3的双重向是可行的,对于切除的NSCLC是安全的.
组合治疗方案显示了令人鼓舞的病理和生存结果.
这种方法有可能改善接受手术的早期NSCLC患者的治疗结果.

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