Martin Thomas G, Madduri Deepu, Pacaud Lida, Usmani Saad Z
Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA 94158, USA.
Janssen Research & Development, Raritan, NJ 08869, USA.
Future Oncol. 2023 Nov;19(34):2297-2311. doi: 10.2217/fon-2022-1317. Epub 2023 Jul 27.
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.
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。
