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Updated: Sep 11, 2025

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在MDM2放大和野生型TP53的高级固体瘤中使用米拉德梅坦:临床前和2期临床试验结果

Ecaterina E Dumbrava¹, Thomas E Stinchcombe², Mrinal Gounder³

¹The University of Texas MD Anderson Cancer Center, Houston, TX, United States.

Clinical cancer research : an official journal of the American Association for Cancer Research

|August 11, 2025

概括

米拉德梅坦在MDM2-放大,TP53-野生型固体瘤中表现出活性,但反应是短暂的. 未来的研究应该探索组合疗法或早期治疗,以获得持续的临床益处.

科学领域:

在瘤学瘤学.
分子生物学分子生物学
药理学药理学是指药理学的学科.

背景情况:

在癌症中,MDM2会放大,降低瘤抑制剂p53,导致p53-null表型.
即使没有TP53突变,这种情况也会发生,这突出了MDM2作为治疗点.

研究的目的:

评估口服MDM2-p53抑制剂米拉迪梅坦的临床前和临床活性.
评估milademetan在MDM2-放大,TP53-野生型固体瘤中的疗效.

主要方法:

米拉德梅坦在实验室模型和II期篮子研究 (MANTRA-2) 中测试了患有高级MDM2amp,TP53-wt固体瘤的患者.
主要终点是客观应答率 (ORR);次要终点包括无进展生存率 (PFS) 和不良事件.

主要成果:

米拉德梅坦在临床前模型中表现出强烈的活性.
在第二阶段试验 (n=40) 中,ORR为19.4% (6/31),有1个确认的部分反应和5个未确认的部分反应.
中位数PFS为3.5个月,常见的3/4级不良事件包括血小板缺血和中性质缺血.

结论:

米拉德梅坦在耐火MDM2amp,TP53-wt固体瘤中表现出可管理的安全性,并诱导反应.
观察到的瘤减少是短暂的,这表明需要结合策略或早期干预才能获得持久的益处.

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