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ciltacabtagene autoleucel 与 idecabtagene vicleucel 治疗既往接受 2-4 线治疗的复发/难治性多发性骨髓瘤患者的疗效比较:一项匹配调整间接比较

英文原题:Comparative efficacy of ciltacabtagene autoleucel versus idecabtagene vicleucel in the treatment of patients with relapsed or refractory multiple myeloma previously treated with 2-4 prior lines of therapy: a matching-adjusted indirect comparison.

查看英文原题

Comparative efficacy of ciltacabtagene autoleucel versus idecabtagene vicleucel in the treatment of patients with relapsed or refractory multiple myeloma previously treated with 2-4 prior lines of therapy: a matching-adjusted indirect comparison.

PubMed 2024/08/22(内容时间) Curr Med Res Opin Q1 · IF 2.8(JCR 2025)

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研究概要

对于接受过 2-4 线既往治疗的三类暴露 RRMM 患者,cilta-cel 在缓解和无进展生存期方面优于 ide-cel,提供了更佳的临床获益。

研究思路结论见上方概要

评估ciltacabtagene autoleucel(cilta-cel)与idecabtagene vicleucel(ide-cel)在接受过2-4线既往治疗的复发/难治性多发性骨髓瘤(RRMM)患者中的相对疗效。

使用CARTITUDE-1和CARTITUDE-4中cilta-cel的个体患者水平数据(IPD)以及KarMMa-3中ide-cel已发表的聚合数据,进行了匹配调整间接比较(MAIC)。筛选出符合KarMMa-3纳入标准的cilta-cel患者,并使用从KarMMa-3聚合水平数据模拟衍生的IPD,将结局与ide-cel的数据进行比较。通过重新加权cilta-cel IPD以匹配KarMMa-3中预后因素的分布,对患者特征进行了调整。使用加权logistic回归分析估计缓解结局的比较疗效,使用加权Cox比例风险模型估计无进展生存期。

接受 cilta-cel 治疗的患者达到总体缓解的可能性是 KarMMa-3 中 ide-cel 患者的 1.2 倍(相对缓解率 [RR]:1.18 [95% 置信区间:1.03-1.34];p = 0.04),达到非常好的部分缓解或更好的可能性是 1.3 倍(RR:1.34 [1.15-1.57];p = 0.003),达到完全缓解或更好的可能性是 1.9 倍(RR:1.91 [1.54-2.37];p < 0.0001)。与 ide-cel 相比,cilta-cel 与疾病进展或死亡风险显著降低 49% 相关(风险比:0.51 [95% 置信区间:0.31, 0.84];p = 0.0078)。

展开英文摘要原文

To estimate the comparative efficacy of ciltacabtagene autoleucel (cilta-cel) versus idecabtagene vicleucel (ide-cel) in patients with relapsed/refractory multiple myeloma (RRMM) treated with 2-4 prior lines of therapy.

Matching adjusted indirect comparison (MAICs) were performed using individual patient-level data (IPD) for cilta-cel from CARTITUDE-1 and CARTITUDE-4 and published aggregated data for ide-cel from KarMMa-3. Cilta-cel patients who met inclusion criteria from KarMMa-3 were selected, and outcomes were compared against data for ide-cel using simulated IPD derived from aggregate-level data from KarMMa-3. Patient characteristics were adjusted by reweighting cilta-cel IPD to match the distribution of prognostic factors in KarMMa-3. Comparative efficacy was estimated for response outcomes using a weighted logistic regression analysis and for progression-free survival using a weighted Cox proportional hazards model.

Patients treated with cilta-cel were 1.2 times more likely to achieve overall response (relative response ratio [RR]: 1.18 [95% confidence interval: 1.03-1.34]; p = 0.04), 1.3 times more likely to achieve very good partial response or better (RR: 1.34 [1.15-1.57]; p = 0.003), and 1.9 times more likely to achieve complete response or better (RR: 1.91 [1.54-2.37]; p < 0.0001) versus ide-cel patients from KarMMa-3. Cilta-cel was associated with a significant 49% reduction in risk of disease progression or death versus ide-cel (hazard ratio: 0.51 [95% confidence interval: 0.31, 0.84]; p = 0.0078).

For patients with triple-class exposed RRMM treated with 2-4 prior lines of treatment, cilta-cel was found to provide superior clinical benefit over ide-cel in terms of response and progression-free survival.

论文信息

作者
Bar N、Diels J、van Sanden S、Mendes J、Hernando T、Burnett H、Cost P、Schecter JM
第一作者单位
Section of Hematology, Department of Internal Medicine, Yale School of Medicine University, New Haven, CT, USA.United States
通讯作者单位
Hematology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.Spain
文献类型
对照研究
期刊
Current medical research and opinion2024 Sep
原文标识
PubMed 39129504 · DOI 10.1080/03007995.2024.2391112