在黑色素瘤中,新辅助剂伊皮利马布加尼沃马布:5年生存率和生物标志物分析来自第二阶段PRADO试验
Lotte L Hoeijmakers1, Petros Dimitriadis1, Steven C M A Wijnen1
1Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Nature medicine
|January 28, 2026
概括
新辅助性 ipilimumab 和 nivolumab 治疗显示了 III 阶段黑色素瘤患者有希望的 5 年生存率. 诸如高瘤突变负担,干扰素-和PD-L1表达等生物标志物预测了有利的结果.
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:
- 新辅助药伊皮利穆马布加尼沃卢马布是治疗III期黑色素瘤的标准药物,但长期数据有限.
- 在OpACIN-neo试验的PRADO队列中,对99名患有宏观III期黑色素瘤的患者进行了评估.
研究的目的:
- 报告新辅助性伊皮利穆马布加尼沃卢马布在III期黑色素瘤中的第一个5年生存数据.
- 确定与有利的长期结果相关的基线生物标志物.
主要方法:
- 第2期临床试验 (OPACIN-neo的PRADO队列) 涉及99名患者.
- 分析了无事件的5年生存率,无复发的生存率,无远程转移的生存率和整体生存率.
- 结果与主要病理反应 (MPR),瘤突变负担 (TMB),干扰素- (IFNγ) 签名和PD-L1表达的相关性.
主要成果:
- 5年生存率:无事件71%;无复发74%;无远程转移79%;整体生存率86%.
- 高的TMB,IFNγ特征和PD-L1表达 (≥1%) 与有利的结果有关.
- 结合高TMB,IFNγ和PD-L1表达导致100%的MPR和100%的5年无事件生存,而三重低表达显示18%的MPR和41%的无事件生存.
结论:
- 新辅助药伊皮利马布加尼沃马布在III期黑色素瘤中显示出有利的长期存活率.
- 主要病理反应 (MPR) 与改善的结果有关.
- 干扰素- (IFNγ) 签名和PD-L1表达是预测治疗反应的有希望的基线生物标志物.
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