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Ciltacabtagene Autoleucel 与标准治疗对既往接受过治疗的复发/难治性多发性骨髓瘤患者的疗效比较:一项匹配调整间接比较

英文原题:Comparative Efficacy of Ciltacabtagene Autoleucel Versus Standard-of-Care Treatments for Patients with Previously Treated Relapsed or Refractory Multiple Myeloma: A Matching-Adjusted Indirect Comparison.

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Comparative Efficacy of Ciltacabtagene Autoleucel Versus Standard-of-Care Treatments for Patients with Previously Treated Relapsed or Refractory Multiple Myeloma: A Matching-Adjusted Indirect Comparison.

PubMed 2025/05/12(内容时间) Adv Ther Q1 · IF 4.7(JCR 2025)

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

研究思路按摘要原文分段

采用匹配调整间接比较(MAICs)比较 cilta-cel 与 elotuzumab + pomalidomide + dexamethasone(EloPd)、isatuximab + carfilzomib + dexamethasone(IsaKd)、isatuximab + pomalidomide + dexamethasone(IsaPd)以及 selinexor + bortezomib + dexamethasone(SVd)在既往接受过至少一种治疗且对 lenalidomide 耐药的复发/难治性多发性骨髓瘤(RRMM)患者中的疗效。

采用非锚定MAIC,使用CARTITUDE-4中随机分配至cilta-cel组的所有单采患者的个体患者水平数据(IPD)(n = 208),以及ELOQUENT-3中EloPd已发表的组水平数据(n = 60)、IKEMA中IsaKd的数据(来那度胺难治亚组,n = 57)、ICARIA-MM中IsaPd的数据(n = 154)和BOSTON中SVd的数据(来那度胺难治亚组,n = 53)。将各对照试验的入组标准应用于cilta-cel组IPD,并通过加权cilta-cel患者数据以匹配对照试验报告的基线特征,进一步调整患者特征中的不平衡。比较疗效估计包括总缓解率、非常好的部分缓解或更好(≥ VGPR)率、完全缓解或更好(≥ CR)率、无进展生存期(PFS)和总生存期(OS)。

校正后,与EloPd、IsaPd和SVd相比,cilta-cel患者达到总体缓解的可能性显著更高,并且与所有对照相比,达到≥VGPR和≥CR的可能性也显著更高。与所有对照相比,cilta-cel患者在疾病进展或死亡(PFS)风险方面也显著降低:与EloPd相比降低64%,与IsaKd相比降低49%,与IsaPd相比降低69%,与SVd相比降低62%。同样,在所有可行的比较中,cilta-cel患者的OS均有显著改善:与EloPd相比改善52%,与IsaPd相比改善58%,与SVd相比改善60%。

Cilta-cel 患者在缓解和生存结局方面相较于 EloPd、IsaKd、IsaPd 和 SVd 显示出具有临床意义的获益,突显了其对于已接受至少一种既往治疗且对来那度胺难治的 RRMM 患者而言优于其他替代治疗方案。

展开英文摘要原文

Unanchored MAICs were performed using individual patient-level data (IPD) for all apheresed patients randomized to the cilta-cel arm of CARTITUDE-4 (n = 208) and published arm-level data for EloPd from ELOQUENT-3 (n = 60), IsaKd from IKEMA (lenalidomide-refractory subgroup, n = 57), IsaPd from ICARIA-MM (n = 154), and SVd from BOSTON (lenalidomide-refractory subgroup, n = 53). Eligibility criteria from each comparator trial were applied to the cilta-cel arm IPD, and further imbalances in patient characteristics were adjusted by weighting the cilta-cel patient data to match the reported baseline characteristics of the comparator trials. Comparative efficacy was estimated for overall response rate, very good partial response or better (≥ VGPR) rate, complete response or better (≥ CR) rate, progression-free survival (PFS), and overall survival (OS).

After adjustment, cilta-cel patients were significantly more likely to achieve an overall response versus EloPd, IsaPd, and SVd, and were significantly more likely to achieve ≥ VGPR and ≥ CR versus all comparators. Cilta-cel patients also had significant reductions in the risk of disease progression or death (PFS) versus all comparators: 64% versus EloPd, 49% versus IsaKd, 69% versus IsaPd, and 62% versus SVd. Similarly, cilta-cel patients had significant improvements in OS for all feasible comparisons: 52% versus EloPd, 58% versus IsaPd, and 60% versus SVd.

Cilta-cel patients demonstrated clinically meaningful benefits over EloPd, IsaKd, IsaPd, and SVd for response and survival outcomes, highlighting its superiority over alternative treatment options for patients with RRMM who have received at least one prior therapy and are refractory to lenalidomide.

论文信息

作者
Puig N、Diels J、van Sanden S、Mendes J、Burnett H、Cichewicz A、Lee S、Hernando T
第一作者单位
Hospital Universitario de Salamanca, Instituto de Investigacion Biomedica de Salamanca, Centro de Investigación del Cancer, Salamanca, Spain.Spain
通讯作者单位
The Janssen Pharmaceutical Companies of Johnson & Johnson, Lisbon, Portugal. jmendes6@ITS.JNJ.com.Portugal
文献类型
对照研究 · 随机对照试验
期刊
Advances in therapy2025 Jul
原文标识
PubMed 40354013 · DOI 10.1007/s12325-025-03205-8