在患有复发性/耐药性卵泡淋巴瘤的成年人中,tisagenlecleucel后的持久反应:ELARA试验更新
Martin Dreyling1, Nathan Hale Fowler2,3, Michael Dickinson4
1Department of Medicine, Medical Clinic III, Ludwig-Maximilian-University Hospital, Munich, Germany.
Blood
|January 9, 2024
概括
Tisagenlecleucel在患有复发性/耐药性卵泡淋巴瘤 (FL) 的成年人中显示出持久的疗效和有利的安全性. 延长后续证实了高响应率和生存率,没有新的安全问题.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
背景情况:
- Tisagenlecleucel已批准用于复发性/耐药性 (r/r) 毛囊淋巴瘤 (FL) 的第三线或后一线治疗.
- 此前,ELARA试验在广泛预治疗的r/rFL患者中显示出高响应率和安全性.
研究的目的:
- 报告来自ELARA试验的长期疗效,安全性,药理动力学和生物标志物数据.
- 为了将基线临床因素和瘤微环境与临床反应相关联.
主要方法:
- 97名患有 r/r FL 的患者接受了 tisagenlecleucel 输液.
- 长期随访 (中位数为29个月) 包括疗效,安全性和生物标志物分析.
- 评估了基线因素和临床反应之间的相关性.
主要成果:
- 预计24个月无进展生存 (PFS),反应持续时间 (DOR) 和整体生存 (OS) 分别为57.4%,66.4%和87.7%.
- 完全响应 (CR) 和整体响应 (ORR) 的比率分别为68.1%和86.2%.
- 低水平的耗尽的T细胞和高水平的原始CD8+T细胞与改善的结果相关. 没有观察到新的安全信号或与治疗相关的死亡.
结论:
- Tisagenlecleucel在r / rFL患者中表现出持续的,持久的疗效和有利的安全概况,随着延长的随访.
- 生物标志物分析表明,对 tisagenlecleucel 治疗的反应的潜在预测因素.
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