在PD-1或PD-L1阻塞耐火转移性转移性黑色素瘤中使用或不使用ipilimumab:一个随机的第二阶段试验
Ari VanderWalde1, Shay L Bellasea2,3, Kari L Kendra4
1The West Clinic-Wolf River, Germantown, TN, USA. avanderwalde@westclinic.com.
Nature medicine
|August 17, 2023
概括
将CTLA-4阻断与PD-1阻断治疗结合起来,可以在转移性黑色素瘤患者中克服原发性耐药性. 与单独使用CTLA-4阻塞相比,这种组合显著改善了无进展生存率.
科学领域:
- 免疫治疗是一种免疫疗法.
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 转移性黑色素瘤患者经常对初始编程细胞死亡1 (PD-1) 阻塞疗法产生抗性.
- 细胞毒性T-淋巴细胞蛋白4 (CTLA-4) 阻断是一种替代性免疫疗法策略.
研究的目的:
- 评估CTLA-4阻断与持续的PD-1阻断相结合的疗效,而不是单独使用CTLA-4阻断,在患有转移性黑色素瘤的患者中,该疗法对先前的抗PD-1疗法有抗性.
- 评估无进展生存期 (PFS),客观反应率 (ORR),总生存期 (OS) 和毒性.
主要方法:
- 一个随机的第二阶段试验,涉及92名符合条件的转移性黑色素瘤患者,他们在前线抗PD-1或抗PD-L1治疗中取得进展.
- 患者被随机分为3:1接受伊皮利马布 (CTLA-4阻断) 加尼沃卢马布 (PD-1阻断) 或单独的伊皮利马布.
- 主要终点是PFS;次要终点包括ORR,OS,毒性和CD8 T细胞透.
主要成果:
- 尼沃卢马布和伊皮利穆马布的组合与单独的伊皮利穆马布相比,在统计学上显著地改善了PFS (HR=0.63,P=0.04).
- 组合手臂的客观响应率为28%,单独用伊皮利姆巴手臂的客观响应率为9% (P=0.05).
- 与治疗相关的3级或更高的不良事件发生在接受联合治疗的57%的患者和接受单独ipilimumab治疗的35%患者中.
结论:
- 结合CTLA-4和PD-1阻断的联合治疗可以在转移性黑色素瘤患者的一个子集中逆转对PD-1阻断的初级耐药性.
- 这种组合策略为那些在初始PD-1基础免疫治疗中取得进展的患者提供了一个有希望的方法.
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