CAR-T(CAR-T)细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CAR-T(CAR-T)细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
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.
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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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。
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.
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