在卵泡淋巴瘤中的利索卡巴丁基马拉莱塞尔:第2阶段TRANSCEND FL研究
Franck Morschhauser1, Saurabh Dahiya2,3, M Lia Palomba4
1Centre Hospitalier Universitaire de Lille, Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France. franck.morschhauser@chu-lille.fr.
Nature medicine
|June 3, 2024
概括
利索卡巴丁基马拉利乌塞尔 (liso-cel) 在复发性/耐药性卵泡淋巴瘤 (FL) 中显示出高响应率,包括高风险的二线患者. 这种CAR T细胞疗法为那些没有满足需求的人提供了一个有前途的选择.
科学领域:
- 在瘤学瘤学.
- 血液学 血液学 血液学
- 免疫治疗是一种免疫疗法.
背景情况:
- 对于复发性/耐火性 (R/R) 毛囊淋巴瘤 (FL) 患者,特别是那些具有POD24或双重耐火性疾病等高风险特征的患者,存在重大未满足的需求.
- 目前对R/R FL的治疗选择有限,对于高风险患者没有确立的护理标准,导致结果不佳.
- 化学抗原受体 (CAR) T细胞疗法是一个新兴的选择,但其最佳时间和疗效在早期的治疗线,特别是二线 (2L) 高风险FL,尚未明确.
研究的目的:
- 评估利索卡巴丁基马拉利乌塞尔 (liso-cel) 的疗效和安全性,这是一种针对CD19的CAR T细胞疗法,用于R/RFL患者.
- 专门评估 liso-cel 在高风险FL特征患者的第二线 (2L) 治疗环境中的性能,包括那些POD24患者.
- 确定TRANSCEND FL研究中作为主要终点的整体响应率 (ORR) 和完整响应率 (CR).
主要方法:
- 第2期TRANSCEND FL研究招募了R/R FL患者,包括具有高风险特征的2L患者队列.
- 患者接受了 lisocabtagene maraleucel (liso-cel),这是一个自身的,CD19导向的,4-1BB CAR T细胞产物.
- 独立审查委员会 (IRC) 评估了整体响应率 (ORR) 和完整响应率 (CR) 作为主要和关键次要终点.
主要成果:
- 在第三行或更高的FL (n=101) 中, liso-cel实现了97%的ORR和94%的CR率.
- 在高风险的2L FL队列 (n=23) 中, liso-cel表现出高ORR为96%,所有响应者都实现了CR.
- 安全性概况包括58%的细胞因子释放综合征 (CRS) (等级≥3.1%) 和15%的神经事件 (等级≥3.2%).
结论:
- 利索卡巴丁基马拉莱塞尔 (liso-cel) 在复发/耐药的卵泡淋巴瘤患者中显示出显著的疗效.
- 该研究满足了其主要和关键的次要终点,显示了高的ORR和CR率,无论是在第三线或更晚和第二线高风险FL.
- 利索细胞为R/RFL提供了可行和有效的治疗选择,包括具有挑战性的高风险二线病例,具有可管理的安全性.
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