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
目的
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。
方法
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。
结果
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
OBJECTIVE
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.
METHODS
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.
RESULTS
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).
CONCLUSION
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