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利索卡巴丁基马拉卢塞尔与二线复发性/耐火性大B细胞淋巴瘤的护理标准:随机的3年随访,第三阶段转化研究
Manali Kamdar1, Scott R Solomon2, Jon Arnason3
1University of Colorado Cancer Center, Aurora, CO.
概括
在二线大B细胞淋巴瘤 (LBCL) 患者中,与标准护理相比,利索卡巴丁基马拉莱塞尔 (liso-cel) 显示出优越,持久的疗效. 三年后的随访证实,利索是一种安全有效的治疗方法,具有治愈潜力.
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:
- 大型B细胞淋巴瘤 (LBCL) 是一种具有攻击性的血液性恶性瘤.
- 在初始治疗后,初级耐火性或早期复发性LBCL的预后不佳.
- 这些患者的标准护理 (SOC) 通常涉及救援化疗,其次是自身干细胞移植 (ASCT).
研究的目的:
- 报告TRANSFORM研究的3年随访结果,比较Lisocabtagene maraleucel (liso-cel) 与SOC在LBCL的二线治疗中.
- 在符合ASCT条件的患者中评估 liso-cel与SOC的长期疗效和安全性.
主要方法:
- 这项TRANSFORM研究是一项随机的1:1试验,涉及184名患有二线原发性耐火性/早期复发性LBCL的成年人.
- 患者被分配接受 liso-cel (100 × 10^6 CAR-T细胞) 或SOC.
- 无事件生存 (EFS),无进展生存 (PFS) 和总生存 (OS) 被描述性地评估,随访时间中位数为33.9个月.
主要成果:
- 利索-细胞 (29.5个月) 与SOC (2.4个月) (HR,0.375) 的中位数EFS显著更长.
- 利索细胞的PFS中位数未达到 (NR) 与SOC的6.2个月相比 (HR,0.422),36个月的PFS率为51%与26.5%.
- 两个手臂的中位数OS是NR,但36个月的OS率为lizo-cel的63%和SOC的52%,在考虑交叉后有利于lizo-cel.
结论:
- 与SOC相比,Lisocabtagene maraleucel在LBCL的二线治疗中表现出更优越和更持久的疗效.
- 在3年的随访中,利索-细胞显示出良好的安全概况,没有新的安全信号.
- 这些发现支持liso-cel作为一种有效的二线治疗,具有治疗复发/耐药LBCL的治疗潜力.
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