西达基奥仑赛与标准治疗方案用于既往治疗过的复发或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
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.
作者信息
Puig Noemi, Diels Joris, van Sanden Suzy, Mendes João, Burnett Heather, Cichewicz Allie, Lee Seina, Hernando Teresa, Schecter Jordan M, Lendvai Nikoletta, Patel Nitin, Sanchez-Pina José María, Rocchi Serena, Mina Roberto, Corradini Paolo, Cavo Michele, Miguel Jesús San, Shune Leyla, Khan Abdullah M, Sidana Surbhi, Leleu Xavier, Manier Salomon, Lipe Brea, Weisel Katja, Martinez-Lopez Joaquin
机构信息
Hospital Universitario de Salamanca, Instituto de Investigacion Biomedica de Salamanca, Centro de Investigación del Cancer, Salamanca, Spain.
The Janssen Pharmaceutical Companies of Johnson & Johnson, Beerse, Belgium.
出版信息
Adv Ther. 2025 May 12. doi: 10.1007/s12325-025-03205-8.
INTRODUCTION
Matching adjusted indirect comparisons (MAICs) were performed to compare the efficacy of cilta-cel versus elotuzumab + pomalidomide + dexamethasone (EloPd), isatuximab + carfilzomib + dexamethasone (IsaKd), isatuximab + pomalidomide + dexamethasone (IsaPd), and selinexor + bortezomib + dexamethasone (SVd) in patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy and are lenalidomide-refractory.
METHODS
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).
RESULTS
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.
CONCLUSION
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.
简介
进行匹配调整间接比较（MAIC）以比较西达基奥仑赛与埃罗妥珠单抗+泊马度胺+地塞米松（EloPd）、isatuximab+卡非佐米+地塞米松（IsaKd）、isatuximab+泊马度胺+地塞米松（IsaPd）以及塞利尼索+硼替佐米+地塞米松（SVd）在复发或难治性多发性骨髓瘤（RRMM）患者中的疗效，这些患者既往至少接受过一种治疗且对来那度胺耐药。
方法
使用所有接受单采的随机分配至CARTITUDE - 4试验西达基奥仑赛组的患者个体水平数据（IPD）（n = 208）以及来自ELOQUENT - 3试验EloPd的已发表的组水平数据（n = 60）、IKEMA试验IsaKd的（来那度胺耐药亚组，n = 57）、ICARIA - MM试验IsaPd的（n = 154）和BOSTON试验SVd的（来那度胺耐药亚组，n = 53）进行非锚定MAIC。将各对照试验的纳入标准应用于西达基奥仑赛组的IPD，并通过对西达基奥仑赛患者数据加权以匹配对照试验报告的基线特征，进一步调整患者特征的不平衡。估计总体缓解率、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）的比较疗效。
结果
调整后，与EloPd、IsaPd和SVd相比，西达基奥仑赛治疗的患者实现总体缓解的可能性显著更高，与所有对照相比，实现≥VGPR和≥CR的可能性也显著更高。与所有对照相比，西达基奥仑赛治疗的患者疾病进展或死亡风险（PFS）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，西达基奥仑赛治疗的患者OS有显著改善：与EloPd相比提高52%，与IsaPd相比提高58%，与SVd相比提高60%。
结论
对于缓解和生存结局，西达基奥仑赛治疗的患者显示出优于EloPd、IsaKd、IsaPd和SVd的具有临床意义的益处，突出了其相对于接受过至少一种既往治疗且对来那度胺耐药的RRMM患者的替代治疗方案的优越性。
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