西达基奥仑赛,一种用于经大量预处理的复发/难治性多发性骨髓瘤患者的靶向B细胞成熟抗原(BCMA)的嵌合抗原受体T细胞(CAR-T)疗法。

Cilta-cel, a BCMA-targeting CAR-T therapy for heavily pretreated patients with relapsed/refractory multiple myeloma.

作者信息

Martin Thomas G, Madduri Deepu, Pacaud Lida, Usmani Saad Z

机构信息

Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA 94158, USA.

Janssen Research & Development, Raritan, NJ 08869, USA.

出版信息

Future Oncol. 2023 Nov;19(34):2297-2311. doi: 10.2217/fon-2022-1317. Epub 2023 Jul 27.

Abstract

Cilta-cel, a BCMA-targeting chimeric antigen receptor T-cell therapy for multiple myeloma, was approved in USA on 28 February 2022, for patients with relapsed or refractory disease who have received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Approval in the EU followed for patients with ≥3 prior therapies. At median 28-month follow-up, the pivotal CARTITUDE-1 trial showed a 98% response rate (83% stringent complete response); median progression-free survival had not been reached, and adverse events could be managed with supportive therapy. Cilta-cel efficacy and safety in earlier lines of therapy, and its optimal sequencing in a complex treatment landscape are important areas of investigation.

摘要

西达基奥仑赛(Cilta-cel)是一种用于治疗多发性骨髓瘤的靶向B细胞成熟抗原(BCMA)的嵌合抗原受体T细胞疗法,于2022年2月28日在美国获批,用于治疗接受过≥4线既往治疗(包括蛋白酶体抑制剂、免疫调节药物和抗CD38单克隆抗体)的复发或难治性疾病患者。欧盟随后批准其用于接受过≥3线既往治疗的患者。在中位28个月的随访中,关键的CARTITUDE-1试验显示缓解率为98%(严格完全缓解率为83%);中位无进展生存期尚未达到,不良事件可用支持性治疗进行处理。西达基奥仑赛在早期治疗线中的疗效和安全性,以及在复杂治疗格局中的最佳用药顺序,都是重要的研究领域。

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