在治疗复发或难治性多发性骨髓瘤患者的 CARTITUDE-1 研究中比较 cilta-cabtagene autoleucel 与 idecabtagene vicleucel 的疗效结局的匹配调整间接比较。
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.
机构信息
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.
Levine Cancer Institute-Atrium Health, Charlotte, NC, USA.
出版信息
Curr Med Res Opin. 2021 Oct;37(10):1779-1788. doi: 10.1080/03007995.2021.1953456. Epub 2021 Jul 23.
OBJECTIVE
This study estimated the comparative efficacy of ciltacabtagene autoleucel (cilta-cel) versus the approved idecabtagene vicleucel (ide-cel) dose range of 300-460 × 10 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).
METHODS
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).
RESULTS
Cilta-cel was associated with statistically significantly improved ORR (odds ratio [OR]: 94.93 [95% confidence interval [CI]: 21.86, 412.25; < .0001]; relative risk [RR]: 1.34), ≥CR rate (OR: 5.49 [95% CI: 2.47, 12.21; < .0001]; RR: 2.21), DoR (hazard ratio [HR]: 0.50 [95% CI: 0.29, 0.87; .0137]), and PFS (HR: 0.37 [95% CI: 0.22, 0.62; = .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; = .0702]).
CONCLUSIONS
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.
目的
本研究使用匹配调整间接治疗比较（MAIC），比较了接受过蛋白酶体抑制剂、免疫调节剂和抗 CD38 单克隆抗体（即三药暴露）治疗的复发或难治性多发性骨髓瘤（RRMM）患者，cilta-cel（CARTITUDE-1；NCT03548207）的个体化患者数据与 ide-cel（KarMMa；NCT03361748）的已发表汇总水平数据，评估 cilta-cel 与批准的 ide-cel 剂量范围 300-460×10 CAR 阳性 T 细胞治疗疗效。
方法
使用匹配调整间接治疗比较（MAIC），比较了接受过蛋白酶体抑制剂、免疫调节剂和抗 CD38 单克隆抗体（即三药暴露）治疗的复发或难治性多发性骨髓瘤（RRMM）患者，cilta-cel（CARTITUDE-1；NCT03548207）的个体化患者数据与 ide-cel（KarMMa；NCT03361748）的已发表汇总水平数据。符合 KarMMa 入选标准的 CARTITUDE-1 接受治疗的患者被纳入分析。MAIC 调整了文献和临床专业知识确定的具有预后意义的不平衡基线协变量。通过评估总体缓解率（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），来评估疗效。
结果
Cilta-cel 与 ORR（比值比 [OR]：94.93 [95%置信区间 [CI]：21.86，412.25； < .0001]）、≥CR 率（OR：5.49 [95% CI：2.47，12.21； < .0001]）、DoR（风险比 [HR]：0.50 [95% CI：0.29，0.87； .0137]）和 PFS（HR：0.37 [95% CI：0.22，0.62； = .0002]）的改善具有统计学意义，而 ide-cel 与 ORR（OR：94.93 [95% CI：21.86，412.25； < .0001]）、≥CR 率（OR：5.49 [95% CI：2.47，12.21； < .0001]）、DoR（HR：0.50 [95% CI：0.29，0.87； .0137]）和 PFS（HR：0.37 [95% CI：0.22，0.62； = .0002]）的改善具有统计学意义，而 ide-cel 与 ORR（OR：94.93 [95% CI：21.86，412.25； < .0001]）、≥CR 率（OR：5.49 [95% CI：2.47，12.21； < .0001]）、DoR（HR：0.50 [95% CI：0.29，0.87； .0137]）和 PFS（HR：0.37 [95% CI：0.22，0.62； = .0002]）的改善具有统计学意义，而 ide-cel 与 OS（HR：0.55 [95% CI：0.29，1.05； = .0702]）的改善具有统计学意义。
结论
与 ide-cel 相比，cilta-cel 对所有结局的疗效均有改善，凸显了其在三药暴露 RRMM 患者中的治疗潜力。
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