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对比西达基奥仑赛与伊达基仑赛治疗既往接受 2-4 线治疗的复发或难治性多发性骨髓瘤患者的疗效:一项匹配调整的间接比较。

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.

机构信息

Section of Hematology, Department of Internal Medicine, Yale School of Medicine University, New Haven, CT, USA.

Janssen Pharmaceutica NV, Beerse, Belgium.

出版信息

Curr Med Res Opin. 2024 Sep;40(9):1597-1603. doi: 10.1080/03007995.2024.2391112. Epub 2024 Aug 22.

Abstract

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];  = 0.04), 1.3 times more likely to achieve very good partial response or better (RR: 1.34 [1.15-1.57];  = 0.003), and 1.9 times more likely to achieve complete response or better (RR: 1.91 [1.54-2.37];  < 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];  = 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.

摘要

目的

评估在接受 2-4 线治疗的复发/难治性多发性骨髓瘤(RRMM)患者中,cilta-cel 对比 idecabtagene vicleucel(ide-cel)的疗效。

方法

使用 CARTITUDE-1 和 CARTITUDE-4 的 cilta-cel 患者个体水平数据(IPD)和 KarMMa-3 的 ide-cel 发表的汇总数据进行匹配调整间接比较(MAIC)。从 KarMMa-3 中选择符合纳入标准的 cilta-cel 患者,使用从 KarMMa-3 的汇总数据中得出的模拟 IPD 与 ide-cel 的数据进行比较。通过重新加权 cilta-cel IPD 来匹配 KarMMa-3 中预后因素的分布,对患者特征进行调整。使用加权逻辑回归分析估计反应结局的疗效,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 治疗的患者总体反应的可能性是接受 ide-cel 治疗的患者的 1.2 倍(相对反应比[RR]:1.18[95%置信区间:1.03-1.34];=0.04),获得非常好的部分缓解或更好缓解的可能性是接受 ide-cel 治疗的患者的 1.3 倍(RR:1.34[1.15-1.57];=0.003),获得完全缓解或更好缓解的可能性是接受 ide-cel 治疗的患者的 1.9 倍(RR:1.91[1.54-2.37];<0.0001)。与来自 KarMMa-3 的 ide-cel 患者相比,cilta-cel 显著降低疾病进展或死亡风险 49%(风险比:0.51[95%置信区间:0.31, 0.84];=0.0078)。

结论

对于接受 2-4 线治疗的三药暴露复发/难治性多发性骨髓瘤患者,与 ide-cel 相比,cilta-cel 在反应和无进展生存期方面具有更好的临床获益。

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