Section of Hematology, Department of Internal Medicine, Yale School of Medicine University, New Haven, CT, USA.
Janssen Pharmaceutica NV, Beerse, Belgium.
Curr Med Res Opin. 2024 Sep;40(9):1597-1603. doi: 10.1080/03007995.2024.2391112. Epub 2024 Aug 22.
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]; = 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).
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.
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。
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。
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)。
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。