对于NPM1-突变的复发性或耐火性急性髓性白血病,使用revumenib抑制阴膜:AUGMENT-101研究
Martha L Arellano1, Michael J Thirman2, John F DiPersio3
1Winship Cancer Institute of Emory University School of Medicine, United States.
Blood
|May 7, 2025
概括
雷文尼布对复发性或耐火性NPM1-突变的AML具有前景,提供有意义的反应,并使重度预治疗的患者能够进行干细胞移植. 这种治疗一般都能很好地忍受.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 复发性或耐火性 (R/R) 核胺1-突变性 (NPM1m) 急性髓性白血病 (AML) 的预后不佳,代表了未满足的医疗需求.
- 雷文尼布是一种脑膜抑制剂,已被批准用于KMT2A转移的急性白血病.
研究的目的:
- 评估revumenib在R/R NPM1m AML.患者中的疗效和安全性.
- 评估完全缓解 (CR) 或具有部分血液恢复 (CRh) 率和整体响应率 (ORR) 的CR.
主要方法:
- 在AUGMENT-101研究的第二阶段,招募了84名R/R NPM1m AML.患者.
- 患者每隔12小时接受revumenib,有或没有CYP3A4抑制剂.
- 疗效分析包括64名重度预治疗的成年患者.
主要成果:
- 在有效性可评估人群中,CR+CRh率为23.4% (P=.0014) 和ORR为46.9%.
- CR+CRh的中位持续时间为4.7个月.
- 五名受试者进行了血造干细胞移植 (HSCT);由于不良事件导致的治疗中止发生在4.8%的患者中.
结论:
- 雷文尼布在R/R NPM1m AML中显示出具有临床意义的反应,包括启用HSCT.
- 安全性概况与之前的研究结果一致.
- 雷梅尼布为这种具有挑战性的AML亚型提供了潜在的新治疗选择.
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