用于复发或耐药的外围T细胞淋巴瘤 (VALENTINE-PTCL01) 患者的瓦莱梅托斯塔特:多中心,开放标签,单臂,第二阶段研究
Pier Luigi Zinzani1, Koji Izutsu2, Neha Mehta-Shah3
1Lymphoma and Chronic Lymphoproliferative Syndromes Unit, Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Bologna, Italy.
The Lancet. Oncology
|November 1, 2024
概括
在患有复发或耐药的外围T细胞淋巴瘤的患者中,瓦莱梅托斯塔特显示出持久的反应. 这种新型EZH2/EZH1抑制剂在VALENTINE-PTCL01试验中显示出可管理的安全性.
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:
- 周围T细胞淋巴瘤 (PTCL) 是一种具有侵略性的非霍奇金淋巴瘤,对于复发性或耐药性疾病的治疗选择有限.
- 瓦莱梅托斯酸是一种针对EZH2和EZH1酶的新型双重抑制剂.
- 研究了valemetostat在PTCL和成人T细胞白血病/淋巴瘤 (ATLL) 的临床活性和安全性.
研究的目的:
- 评估valemetostat在患有复发或耐药PTCL的患者中的疗效和安全性.
- 评估瓦莱梅托斯塔特在复发性或耐火性ATLL患者的安全性和耐受性.
主要方法:
- 一个多中心,开放标签,单臂,第二阶段试验 (VALENTINE-PTCL01) 招募了18岁以上的患者,ECOG性能状态为0-2.
- 患者每天服用口服valemetostat200毫克,直到疾病进展或毒性.
- PTCL的主要疗效终点是BICR的客观反应率 (ORR);ATLL的主要安全终点是安全性和耐受性.
主要成果:
- 纳入了133名复发/耐药PTCL患者和22名ATLL患者.
- 在可有效性评估的PTCL患者中,客观应答率 (ORR) 为44% (95%CI 35-53).
- 最常见的3-4级不良事件包括血小板缺血 (23%PTCL,50%ATLL),贫血 (19%PTCL,46%ATLL) 和中性质缺血 (17%PTCL,18%ATLL). 严重的治疗不良事件发生在40%的PTCL患者和68%的ATLL患者中.
结论:
- 在患有复发性或耐火性PTCL的患者中,valemetostat治疗导致了持久的反应.
- 在研究的患者群体中,valemetostat的安全性概况是可控的.
- 这些发现支持valemetostat作为PTCL的潜在治疗选择.
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