在晚期黑色素瘤中使用尼沃卢马布和雷拉利马布的整体存活率和反应率
Georgina V Long1, F Stephen Hodi2, Evan J Lipson3
1Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney.
NEJM evidence
|February 6, 2024
概括
尼沃卢马布和relatlimab的组合在晚期黑色素瘤患者中显示出显著的无进展生存益处. 虽然整体存活率没有达到统计学意义,但与单独使用nivolumab相比,这种组合显示出更高的客观响应率.
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:
- 在RELATIVITY-047试验中,研究了尼沃卢马布和relatlimab在晚期黑色素瘤中的固定剂量组合.
- 之前的研究结果表明,与尼沃卢马布单独治疗相比,组合治疗具有无进展生存 (PFS) 的优势.
研究的目的:
- 报告来自RELATIVITY-047试验的更新的PFS和安全数据.
- 为了呈现初始整体存活率 (OS) 和客观响应率 (ORR) 的结果,尼沃卢马布加relatlimab组合疗法.
主要方法:
- 以前未经治疗的不可切除或转移性黑色素瘤患者被随机分配1:1接受nivolumab + relatlimab或每4周内静脉注射一次nivolumab.
- 无进展生存 (PFS) 是主要终点,通过盲目的独立中央审查 (BICR) 评估,使用固体瘤响应评估标准 (RECIST) v1.1.1.
- 总生存率 (OS) 和客观反应率 (ORR) 是关键的二次终点,也由BICR评估.
主要成果:
- 随访时间中位数为19.3个月,尼沃卢马布+莱特利马布的PFS中位数为10.2个月,仅尼沃卢马布的PFS为4.6个月 (HR,0.78;P=0.04).
- 两只手臂均未达到中位数,但危险比为0.80 (P=0.059),不符合预先规定的显著性水平.
- 组合治疗的客观反应率为43.1%,仅用尼沃卢马布治疗的比例为32.6%.
结论:
- 尼沃卢马布和relatlimab的固定剂量组合在晚期黑色素瘤患者中始终显示PFS益处.
- 虽然OS没有达到统计学意义,但该组合在ORR中显示出显著的差异.
- 与3/4级治疗相关的不良事件的更高率被观察到,与尼沃卢马布单独治疗相比,尼沃卢马布加relatlimab组合治疗.
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