在患有复发或耐火性非霍奇金淋巴瘤的患者中使用瓦莱梅托斯单疗法:这是首次在人体上进行多中心,开放标签,单臂,第一阶段研究
Dai Maruyama1, Eric Jacobsen2, Pierluigi Porcu3
1Department of Hematology, National Cancer Center Hospital, Tokyo, Japan; Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
The Lancet. Oncology
|November 1, 2024
概括
瓦莱梅托斯塔特是一种新型EZH2/EZH1抑制剂,在复发性或耐火性非霍奇金淋巴瘤患者中显示出可接受的安全性和有利的临床活性. 这些发现支持其作为这种患者群体的新治疗选择的潜力.
科学领域:
- 在瘤学瘤学.
- 血液学 血液学 血液学
- 药理学 药理学是指药理学的学科.
背景情况:
- 对于复发性或耐火性非霍奇金淋巴瘤 (NHL) 的治疗选择有限.
- 与先进NHL的当前疗法相关的不良结果.
- 需要针对EZH2和EZH1通路的新型治疗剂.
研究的目的:
- 评估valemetostat的安全性和初步临床活性.
- 确定valemetostat的推第二阶段剂量 (RP2D).
- 评估valemetostat在NHL复发/耐药患者中的抗瘤活性.
主要方法:
- 第1期,多中心,开放标签,单臂试验 (NCT02732275).
- 在90名患者中进行口服瓦莱梅托斯塔特剂量升级和剂量扩展研究.
- 评估了安全性,药理动力学和抗瘤活性;根据IWG 2007和修改后的2009标准评估了反应.
主要成果:
- 瓦莱梅托斯塔特一般耐受良好;没有发生与治疗相关的死亡.
- 最常见的不良事件:血小板数量下降 (58%),失血 (50%),贫血 (42%).
- 总体应答率 (ORR) 为54.5%;RP2D确定为每天200mg.
结论:
- 瓦莱梅托斯塔特单疗法在复发性/耐药性NHL中显示出可接受的安全性.
- 观察到有利的临床活性,支持其作为新疗法的潜力.
- 需要进一步研究NHL中的valemetostat.
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