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在复发性或耐火性NPM1突变AML中使用齐夫托梅尼布

Eunice S Wang¹, Pau Montesinos², James Foran³

¹Roswell Park Comprehensive Cancer Center, Buffalo, NY.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

|September 25, 2025

概括

齐夫托梅尼布对复发性/耐药性NPM1-突变的AML显示出显著的临床益处. 这种口服脑膜抑制剂耐受性良好,在重度预治疗的患者中表现出可控的副作用和深度反应.

科学领域:

血液学血液学血液学
在瘤学瘤学.
药理学药理学是指药理学的学科.

背景情况:

与NPM1突变 (NPM1-m) 复发/不耐药的急性髓性白血病 (AML) 呈现出显著的未满足需求.
针对性治疗为AML提供了一种新的治疗策略.

研究的目的:

评估强烈的口服脑膜抑制剂齐夫托梅尼布 (ziftomenib) 的疗效和安全性,作为复发性/耐药NPM1-mAML的单疗法.
在接受齐夫托梅尼布治疗的患者中,确定完全缓解 (CR) 或具有部分血液恢复 (CRh) 的CR率.

主要方法:

在KOMET-001试验的第二阶段,纳入了复发/耐药NPM1-mAML的患者.
齐夫托梅尼布是每天服用一次600毫克的药物.
主要终点是CR/CRh比率.

主要成果:

CR/CRh率为22% (95% CI,14-32),符合主要终点.
61%的患者获得了可测量的残留疾病负面影响.
总体应答率为33%,平均持续时间为4.6个月. 常见的不良事件包括发烧性中性质衰竭,贫血和血栓细胞衰竭. 差异化综合征发生在25%的患者中,并且可以控制.

结论:

齐夫托梅尼布在重复/耐药NPM1-mAML的重度预治疗患者中显示出显著的临床益处和深度反应.
该药物耐受性良好,具有可管理的安全性,包括差异化综合征.
齐夫托梅尼布为这种患者群体提供了一个有前途的向治疗方法.

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