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lisocabtagene maraleucel 对比 axicabtagene ciloleucel 用于早期复发/难治性大 B 细胞淋巴瘤患者二线治疗的匹配调整间接比较

英文原题:Matching-adjusted indirect comparison of lisocabtagene maraleucel versus axicabtagene ciloleucel for second-line treatment of patients with early relapsed or refractory large B-cell lymphoma.

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Matching-adjusted indirect comparison of lisocabtagene maraleucel versus axicabtagene ciloleucel for second-line treatment of patients with early relapsed or refractory large B-cell lymphoma.

PubMed 2025/07/24(内容时间) Leuk Lymphoma Q3 · IF 2.1(JCR 2025)

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中文摘要

在缺乏CAR-T 细胞疗法头对头试验的情况下,一项匹配调整间接比较(MAIC)评估了lisocabtagene maraleucel(liso-cel)与axicabtagene ciloleucel(axi-cel)作为二线(2L)治疗用于早期复发/难治性(R/R)大B细胞淋巴瘤(LBCL)患者的比较疗效和安全性。数据来源为关键性3期试验:来自TRANSFORM的个体患者水平数据[liso-cel(NCT03575351),N = 184]和来自ZUMA-7的汇总水平数据[axi-cel(NCT03391466),N = 359]。疗效分析通过共同的标准治疗对照臂进行锚定,未显示统计学显著差异。安全性分析为非锚定,显示liso-cel发生3级严重治疗中出现的不良事件[0.49(0.27-0.90)]、细胞因子释放综合征[任何级别,0.09(0.04-0.18);3级,0.09(0.01-0.75)]和神经系统事件[任何级别,0.08(0.03-0.18);3级,0.21(0.06-0.68)]的比值(95%置信区间)更低。在这项MAIC中,liso-cel在R/R LBCL的2L治疗中相较于axi-cel表现出相当的疗效和更有利的安全性特征。

展开英文摘要原文

In the absence of head-to-head trials of chimeric antigen receptor T-cell therapies, a matching-adjusted indirect comparison (MAIC) evaluated the comparative efficacy and safety of lisocabtagene maraleucel (liso-cel) versus axicabtagene ciloleucel (axi-cel) as second-line (2L) therapies in patients with early relapsed or refractory (R/R) large B-cell lymphoma (LBCL). Data sources were the pivotal phase 3 trials: individual patient-level data from TRANSFORM [liso-cel (NCT03575351), N = 184] and summary-level data from ZUMA-7 [axi-cel (NCT03391466), N = 359].

Efficacy analyses were anchored via the common standard-of-care comparator arms and showed no statistically significant differences. Safety analyses were unanchored, showing liso-cel had lower odds (95% confidence interval) of grade 3 serious treatment-emergent adverse events [0. 49 (0. 27-0.

90)], cytokine release syndrome [any grade, 0. 09 (0. 04-0. 18); grade 3, 0. 09 (0. 01-0. 75)], and neurological events [any grade, 0. 08 (0. 03-0. 18); grade 3, 0. 21 (0. 06-0. 68)]. In this MAIC, liso-cel demonstrated comparable efficacy and a more favorable safety profile versus axi-cel for 2L treatment of R/R LBCL.

论文信息

作者
Abramson JS、Kamdar M、Liu FF、Crotta A、Previtali A、Klijn SL、Wang P、Zhang Y
第一作者单位
Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.United States
通讯作者单位
University of Nebraska Medical Center, Omaha, NE, USA.United States
文献类型
对照研究 · III 期临床试验
期刊
Leukemia & lymphoma2025 Dec
原文标识
PubMed 40708270 · DOI 10.1080/10428194.2025.2532674