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在9岁时治疗切除的III或IV期黑色素瘤的尼沃卢马布

Paolo A Ascierto¹, Michele Del Vecchio², Barbara Merelli³

¹Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale, Naples, Italy.

The New England journal of medicine

|October 22, 2025

概括

在黑色素瘤患者中,尼沃卢马布显著改善了无复发的生存率,与伊皮利穆巴相比,在9年内观察到持续的好处. 这种免疫疗法在预防黑色素瘤复发和远程转移方面提供了持久的优势.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
黑色素瘤研究黑色素瘤研究

背景情况:

检查Mate 238试验显示,在切除的IIIB-C/IV阶段黑色素瘤中,nivolumab与ipilimumab的无复发生存率 (RFS) 比较高.
为了进一步评估这些治疗方法的疗效,需要长期生存数据.

研究的目的:

评估长期生存结果,包括无复发生存 (RFS),无远程转移生存 (DMFS) 和整体生存 (OS).
在延长的随访期内评估nivolumab与ipilimumab相比的安全概况.

主要方法:

随机, 1:1分配给尼沃卢马布 (3毫克/千克Q2W) 或伊皮利穆马布 (10毫克/千克Q3W为4剂量,然后Q12W) 长达1年或直到疾病进展/毒性.
根据疾病阶段和PD-L1状态进行分层.
主要终点:RFS. 二级终点:DMFS,操作系统和安全.

主要成果:

在约9年的随访期内,中位数的RFS为61.1个月 (尼沃卢马布) 与24.2个月 (伊皮利穆马布);9年的RFS为44%与37%.
在III期患者中,DMFS的中位数超过了9年 (nivolumab) 和83.8个月 (ipilimumab);9年的DMFS为54%和48%.
在这两组中,中位数的生存寿命都超过了9年;9年生存率为69% (尼沃卢马布) 和65% (伊皮利穆马布). 较少的患者接受了尼沃卢马布 (37.3%) 和伊皮利穆马布 (44.6%) 的后续治疗. 没有报告新的晚期不良事件.

结论:

最终的9年数据证实,在切除的IIIB-C/IV阶段黑色素瘤中,nivolumab与ipilimumab相比,具有持续优异的无复发生存期.
尼沃卢马布在这种患者群体中显示出长期生存益处和良好的安全性.

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