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在复发和难治性多发性骨髓瘤中,idecabtagene vicleucel(ide-cel,bb2121)与 selinexor + 地塞米松和 belantamab mafodotin 的疗效结局的匹配调整间接比较。

Matching adjusted indirect comparisons of efficacy outcomes for idecabtagene vicleucel (ide-cel, bb2121) versus selinexor + dexamethasone and belantamab mafodotin in relapsed and refractory multiple myeloma.

机构信息

Clínica Universidad de Navarra, Pamplona, Spain.

PRECISIONheor, Vancouver, BC, Canada.

出版信息

Leuk Lymphoma. 2021 Oct;62(10):2482-2491. doi: 10.1080/10428194.2021.1913143. Epub 2021 Apr 24.

DOI:10.1080/10428194.2021.1913143
PMID:33896344
Abstract

Idecabtagene vicleucel (ide-cel, bb2121), a chimeric antigen receptor (CAR) T cell therapy, has been investigated in patients with relapsed and refractory multiple myeloma (RRMM) who have received an immunomodulatory drug, proteasome inhibitor, and anti-CD38 antibody in the single-arm phase 2 KarMMa clinical trial. Two therapies with distinct mechanisms of action - selinexor plus dexamethasone (Sd) and belantamab mafodotin (BM) - are currently approved in the United States for heavily pretreated patients, including those who are triple-class refractory. To compare ide-cel versus Sd and ide-cel versus BM, matching-adjusted indirect comparisons were performed. Ide-cel extended progression-free survival (PFS) and overall survival (OS) versus both Sd and BM (hazard ratio (HR); 95% confidence interval (CI)). PFS: ide-cel versus Sd, 0.46; 0.28-0.75; ide-cel versus BM, 0.45; 0.27-0.77. OS: ide-cel versus Sd, 0.23; 0.13-0.42; ide-cel versus BM, 0.35; 0.14-0.87. These results suggest ide-cel offers clinically meaningful improvements over currently approved regimens for patients with heavily pretreated RRMM.

摘要

伊达基仑(ide-cel,bb2121)是一种嵌合抗原受体(CAR)T 细胞疗法,在接受过免疫调节剂、蛋白酶体抑制剂和抗 CD38 抗体治疗的复发/难治性多发性骨髓瘤(RRMM)患者中进行了研究,这些患者在单臂 2 期 KarMMa 临床试验中。两种具有不同作用机制的疗法——塞利尼索联合地塞米松(Sd)和贝兰他单抗mafodotin(BM)——目前在美国被批准用于接受过多线治疗的患者,包括三药难治的患者。为了比较 ide-cel 与 Sd 和 ide-cel 与 BM,进行了匹配调整的间接比较。与 Sd 和 BM 相比,ide-cel 延长了无进展生存期(PFS)和总生存期(OS)(风险比(HR);95%置信区间(CI))。PFS:ide-cel 与 Sd 相比,0.46;0.28-0.75;ide-cel 与 BM 相比,0.45;0.27-0.77。OS:ide-cel 与 Sd 相比,0.23;0.13-0.42;ide-cel 与 BM 相比,0.35;0.14-0.87。这些结果表明,ide-cel 为接受过多线治疗的 RRMM 患者提供了比目前批准的方案更有临床意义的改善。

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