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塞米普利马布加上peltopepimut-S疫苗治疗宫癌复发:一项2期临床试验

Domenica Lorusso¹, Ana Oaknin², Giuliano S Borges³

¹Humanitas San Pio X, Milan, Italy; Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

Gynecologic oncology

|March 28, 2025

概括

塞米普利马布加上peltopepimut-S疫苗在复发性HPV16+宫癌患者的化疗后显示出临床益处. 更高的PD-L1表达可能会预测这种免疫疗法组合的更好反应.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
宫癌研究研究宫癌研究

背景情况:

在一线化疗失败后,复发的HPV16+宫癌构成了重大治疗挑战.
确定有效的救援疗法对于改善患者的治疗结果至关重要.

研究的目的:

评估在患有复发性HPV16+子宫癌的患者中将塞米普利马布与peltopepimut-S疫苗结合使用的临床疗效和安全性.
评估客观反应率 (ORR),反应持续时间 (DOR),整体存活率 (OS) 和无进展存活率 (PFS).

主要方法:

一项全球性,第二阶段的开放性研究 (NCT04646005) 招募了113名患者,在一线化疗后进展.
患者每三周内接受三剂peltopepimut-S疫苗和静脉注射塞米普利马布.
主要终点是ORR by RECIST v1.1;次要终点包括DOR,OS,PFS和安全性.

主要成果:

客观响应率 (ORR) 为16.8%.
中位数DOR为5.6个月;中位数OS为13.3个月;中位数PFS为3.0个月.
治疗引起的不良事件发生在92.9%的患者中,最常见的是注射部位反应和贫血. 六个死亡被归因于TEAE.

结论:

塞米普利马布加上peltopepimut-S疫苗在这个患者群体中显示出临床益处.
瘤细胞中PD-L1表达率较高可能表明这种组合疗法受益的可能性更高.
安全性概况与已知的毒性相一致.

关键词:

在Cemiplimab的墓地里宫癌是发生在宫癌的原因之一.在HPV16中,HPV16是最重要的.佩尔托佩皮皮穆特-S 疫苗复发性/转移性复发性/转移性

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