肿瘤细胞治疗研究
英文原题：Updated results from a 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.
Updated results from a 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，在更长时间的随访中，cilta-cel 相比 ide-cel 在所有结局上均显示出更优的疗效，并突显了其在对三类药物暴露的 RRMM 患者中的治疗潜力。
本研究使用CARTITUDE-1和KarMMa临床试验的最新可用数据截止点，更新了先前发表的匹配调整间接治疗比较（MAIC），评估ciltacabtagene autoleucel（cilta-cel）与FDA批准的idecabtagene vicleucel（ide-cel）300至450 × 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。
采用cilta-cel（CARTITUDE-1）最新可获得的个体患者数据以及ide-cel（KarMMa）已发表的汇总水平数据进行了MAIC。分析纳入了CARTITUDE-1中符合KarMMa入组标准的接受治疗的患者。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校正。比较疗效评估的指标包括总缓解率（ORR）、完全缓解或更好（≥CR）率、缓解持续时间（DoR）、无进展生存期（PFS）和总生存期（OS）。
Cilta-cel 与 ide-cel 相比，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：5.65 [95% CI：2.51, 12.69；p < .0001]；RR：2.23）、DoR（风险比 [HR]：0.52 [95% CI：0.30, 0.88；p = .0152]）、PFS（HR：0.38 [95% CI：0.24, 0.62；p < .0001]）和 OS（HR：0.43 [95% CI：0.22, 0.88；p = .0200]）相关。
This study used the latest available data cuts from the CARTITUDE-1 and KarMMa clinical trials to update previously published matching-adjusted indirect treatment comparisons (MAICs) assessing the comparative efficacy of ciltacabtagene autoleucel (cilta-cel) versus the FDA-approved idecabtagene vicleucel (ide-cel) dose range of 300 to 450 × 10 6 CAR-positive T-cells in 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).
MAICs were performed with the latest available individual patient data for cilta-cel (CARTITUDE-1) and published summary-level data for ide-cel (KarMMa). The analyses included treated patients from CARTITUDE-1 who satisfied the eligibility criteria for KarMMa. The MAIC adjusted for unbalanced baseline covariates of prognostic significance identified in the literature and by clinical expertise. Comparative efficacy was assessed 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: 5.65 [95% CI: 2.51, 12.69; p < .0001]; RR: 2.23), DoR (hazard ratio [HR]: 0.52 [95% CI: 0.30, 0.88; p = .0152]), PFS, (HR: 0.38 [95% CI: 0.24, 0.62; p < .0001]), and OS (HR: 0.43 [95% CI: 0.22, 0.88; p = .0200]) compared with ide-cel.
These analyses demonstrate improved efficacy with cilta-cel versus ide-cel for all outcomes over longer follow-up and highlight its therapeutic potential in triple-class exposed RRMM patients.
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