对于KMT2A-重新安排的复发性或耐火性急性白血病 (AUGMENT-101) 的revumenib的男性抑制
Ghayas C Issa1, Ibrahim Aldoss2, Michael J Thirman3
1Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
概括
雷文尼布在治疗复发性/耐药性KMT2A重组性急性白血病方面表现出显著的疗效,在大量患者队列中实现了高缓解率和可管理的安全性.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 分子生物学分子生物学
背景情况:
- 重组KMT2A (KMT2Ar) 的急性白血病是一个具有挑战性的诊断,治疗选择有限.
- 雷文尼布向的是KMT2A的menin相互作用,这是KMT2Ar白血病的关键驱动因素.
研究的目的:
- 为了评估revumenib在复发/耐药 (R/R) KMT2Ar急性白血病患者中的疗效和安全性.
- 在这个患者群体中评估完全缓解 (CR) 或CR与部分血液恢复 (CR + CRh) 率.
主要方法:
- 一/二期,开放标签,剂量升级和扩展研究 (AUGMENT-101).
- 招募的患者年龄≥30天,患有R/R KMT2Ar急性白血病.
- 在28天周期中,Revumenib每12小时口服一次.
主要成果:
- 94名患者接受治疗;57名患者的疗效可评估.
- CR + CRh率为22.8% (95% CI,12.7至35.8),超过了零假设 (P = .0036).
- 总体应答率为63.2%,其中68.2%的患者没有可检测的残留疾病.
结论:
- 雷文尼布在R/R KMT2Ar急性白血病中显示出高缓解率和可预测的安全性.
- 这项研究代表了针对KMT2Ar急性白血病的向治疗的最大评估.
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