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在日本患有晚期非小细胞肺癌的患者中使用Cemiplimab

Yuki Sato¹, Yoko Tani², Hidenobu Ishii³

¹Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.

Japanese journal of clinical oncology

|October 29, 2025

概括

塞米普利马布在患有晚期非小细胞肺癌 (aNSCLC) 的日本患者中显示出有效性. 它对PD-L1≥50%的单一治疗和任何PD-L1表达的化疗有效,显示出有利的益处风险概况.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
药理学药理学是指药理学的学科.

背景情况:

之前的研究 (EMPOWER-Lung 1 和 3) 在非日本先进非小细胞肺癌 (aNSCLC) 患者中显示出塞米普利马布的益处.
这项研究专注于日本aNSCLC患者,评估一线塞米普利马布的疗效和安全性.

研究的目的:

评估塞米普利马布在日本aNSCLC患者的安全性,耐受性,药理动力学和疗效.
评估塞米普利马布作为单疗法或与化疗结合使用.

主要方法:

一个单臂,剂量扩展研究在日本患者与aNSCLC.
队列A:Cemiplimab单一治疗PD-L1≥50% (n=60安全性,n=50有效性).
队列C:对于任何PD-L1表达 (n=50),Cemiplimab加上化疗.

主要成果:

安全性与塞米普利马布已知的特征一致;治疗发生的≥3级不良事件发生在51.7% (A队列) 和68.0% (C队列) 中.
客观反应率 (ORR) 为60.0% (A队列) 和42.0% (C队列),反应持续时间 (DOR) 分别为2.1-42.5个月和2.3-20.7个月.
药理动力学在所有队列中都是相似的,免疫原性是低的.

结论:

在日本的PD-L1 ≥50%aNSCLC患者中,Cemiplimab作为单一疗法的疗效被证明是有效的.
塞米普利马布加化学疗法在这个人群中,无论PD-L1表达如何,都显示出有效性.
对于日本患有aNSCLC的患者来说,Cemiplimab具有有利的益处风险概况.

关键词:

临床试验是指临床试验中的临床试验.免疫检查点抑制剂免疫检查点抑制剂免疫疗法免疫疗法非小细胞肺癌的肺癌.

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