在III/IV阶段黑色素瘤中辅助尼沃卢马布和relatlimab:随机的第三阶段RELATIVITY-098试验
Georgina V Long1, Charlie Garnett-Benson2, Sonia Dolfi2
1Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia. georgina.long@sydney.edu.au.
Nature medicine
|October 18, 2025
概括
在被切除的黑色素瘤中,辅助尼沃卢马布加上relatlimab与单独的尼沃卢马布相比,没有改善无复发的存活率. 这种组合疗法虽然对晚期黑色素瘤有效,但在切除病例的辅助治疗中没有显示出任何额外的益处.
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:
- 先进的黑色素瘤治疗已经看到了成功的nivolumab加relatlimab.
- 对于完全切除的黑色素瘤,还需要更有效的辅助疗法.
- 在RELATIVITY-098试验中,研究了被切除的黑色素瘤的辅助剂尼沃卢马布加上relatlimab.
研究的目的:
- 为了比较辅助尼沃卢马布加莱特利马布与单独尼沃卢马布在完全切除的III/IV阶段黑色素瘤患者的疗效.
- 评估无复发生存率 (RFS) 作为主要终点和整体生存率作为关键的次要终点.
主要方法:
- 第三阶段,双盲,随机试验 (RELATIVITY-098) 涉及1093名患者.
- 患者接受480毫克的尼沃卢马布加上160毫克的relatlimab或480毫克的尼沃卢马布静脉注射每4周,长达1年.
- 主要终点:RFS. 二级终点:整体存活率. 翻译终点是探索性的.
主要成果:
- 在nivolumab加relatlimab和单独nivolumab之间没有显著的RFS差异 (HR=1.01,P=0.928).
- 由于RFS没有差异,因此没有测试整体存活率.
- 翻译数据表明,与晚期黑色素瘤相比,辅助剂的LAG-3+T细胞循环量较低.
结论:
- 辅助尼沃卢马布加上relatlimab在切除黑色素瘤的无复发生存方面没有显示出比单独尼沃卢马布的附加益处.
- 在辅助的环境下,较低的外围LAG-3+T细胞可能解释了与转移性疾病相比缺乏益处.
- 可能需要进一步的研究来确定患者群体,这些患者可以从辅助组合中受益.
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