CANOPY-N:Canakinumab或Pembrolizumab单独或组合的第二阶段研究,作为可切除,IB-IIIA期NSCLC患者的新辅助疗法
Jay M Lee1, Jean-Louis Pujol2, Jun Zhang3
1UCLA Health, Los Angeles, California.
JTO clinical and research reports
|August 14, 2025
概括
新辅助药卡纳基努马布,单独或与潘布罗利祖马布一起,在早期非小细胞肺癌 (NSCLC) 中没有改善主要病理反应率. 组合治疗没有增加安全问题或不良外科结果.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 卡纳基努马布 (Canakinumab) 是一种抗联素-1β抗体,可以通过减少前瘤炎症来增强编程死亡配体1 (PD-1) 抑制剂的疗效.
- 早期非小细胞肺癌 (NSCLC) 治疗策略正在与新辅助免疫疗法一起发展.
研究的目的:
- 评估新助剂卡纳基努马布和潘布罗利祖马布在早期NSCLC患者的安全性和疗效.
- 为了确定单独或与 pembrolizumab 结合使用的 canakinumab 是否改善了主要病理反应 (MPR) 比率,而不是单独使用 pembrolizumab.
主要方法:
- 一项随机的第二阶段研究 (CANOPY-N) 招募了88名患有Ib-IIIa期NSCLC的患者.
- 患者接受了新辅助药卡纳基努马布,布罗利祖马布或其组合,MPR率作为主要终点.
- 二级终点包括整体反应率,安全性,药理动力学和手术结果.
主要成果:
- 卡纳基努马布的MPR率为2.9%,卡纳基努马布+佩布罗利祖马布为17.1%,佩布罗利祖马布为16.7%.
- 在任何治疗组中都没有观察到意外的安全信号.
- 手术结果没有受到不利影响,85.7%的患者达到6周的手术窗口.
结论:
- 新辅助药卡纳基努马布,单独或与潘布罗利祖马布结合,与潘布罗利祖马布单独治疗相比,没有提高MPR率.
- 卡纳基努马布显示了可接受的安全性概况,并没有对手术可行性或结果产生负面影响.
- 在新辅助免疫疗法后,手术内纤维化很少发生.
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