肿瘤细胞治疗研究
英文原题：Matching-adjusted indirect comparison of efficacy outcomes for ciltacabtagene autoleucel in CARTITUDE-1 versus idecabtagene vicleucel in KarMMa for the treatment of patients with relapsed or refractory multiple myeloma.
Matching-adjusted indirect comparison of efficacy outcomes for ciltacabtagene autoleucel in CARTITUDE-1 versus idecabtagene vicleucel in KarMMa for the treatment of patients with relapsed or refractory multiple myeloma.
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这些分析表明，与 ide-cel 相比，cilta-cel 在所有结局上均显示出更优的疗效，突显了其在对三类药物暴露的 RRMM 患者中的治疗潜力。
本研究采用匹配调整间接治疗比较（MAIC）方法，评估了ciltacabtagene autoleucel（cilta-cel）与已获批的idecabtagene vicleucel（ide-cel）300-460 × 10 6 CAR阳性T细胞剂量范围在治疗既往接受过蛋白酶体抑制剂、免疫调节药物和抗CD38单克隆抗体（即三类暴露）的复发/难治性多发性骨髓瘤（RRMM）患者中的比较疗效。
MAIC 使用 cilta-cel 的个体患者数据（CARTITUDE-1；NCT03548207）和 ide-cel 已发表的汇总水平数据（KarMMa；NCT03361748）进行。CARTITUDE-1 中符合 KarMMa 入组标准的接受治疗患者被纳入分析。MAIC 对文献中及临床专业知识所确定的具有预后意义的基线协变量不平衡进行了调整。比较疗效估计包括 ORR、≥CR 率、DoR、PFS 和 OS。
与ide-cel相比，cilta-cel与统计学显著改善的ORR（比值比[OR]：94.93 [95%置信区间[CI]：21.86, 412.25；p < .0001]；相对风险[RR]：1.34）、≥CR率（OR：5.49 [95% CI：2.47, 12.21；p < .0001]；RR：2.21）、DoR（风险比[HR]：0.50 [95% CI：0.29, 0.87；p = .0137]）和PFS（HR：0.37 [95% CI：0.22, 0.62；p = .0002）相关。对于OS，结果倾向于cilta-cel且具有临床意义，但CI跨越1（HR：0.55 [95% CI：0.29, 1.05；p = .0702]）。
This study estimated the comparative efficacy of ciltacabtagene autoleucel (cilta-cel) versus the approved idecabtagene vicleucel (ide-cel) dose range of 300-460 × 10 6 CAR-positive T-cells for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who were previously treated with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody (i.e. triple-class exposed) using matching-adjusted indirect treatment comparisons (MAICs).
MAICs were performed with individual patient data for cilta-cel (CARTITUDE-1; NCT03548207) and published summary-level data for ide-cel (KarMMa; NCT03361748). Treated patients from CARTITUDE-1 who satisfied the eligibility criteria for KarMMa were included in the analyses. The MAIC adjusted for unbalanced baseline covariates of prognostic significance identified in the literature and by clinical expertise. Comparative efficacy was estimated for overall response rate (ORR), complete response or better (≥CR) rate, duration of response (DoR), progression-free survival (PFS), and overall survival (OS).
Cilta-cel was associated with statistically significantly improved ORR (odds ratio [OR]: 94.93 [95% confidence interval [CI]: 21.86, 412.25; p < .0001]; relative risk [RR]: 1.34), ≥CR rate (OR: 5.49 [95% CI: 2.47, 12.21; p < .0001]; RR: 2.21), DoR (hazard ratio [HR]: 0.50 [95% CI: 0.29, 0.87; p = .0137]), and PFS (HR: 0.37 [95% CI: 0.22, 0.62; p = .0002]) when compared with ide-cel. For OS, the results were in favor of cilta-cel and clinically meaningful but with a CI overlapping one (HR: 0.55 [95% CI: 0.29, 1.05; p = .0702]).
These analyses demonstrate improved efficacy with cilta-cel versus ide-cel for all outcomes, highlighting its therapeutic potential in patients with triple-class exposed RRMM.
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