Derman Benjamin, Tan Carlyn, Steinfield Ian, Wilson Florence R, Lin Dee, Wu Bingcao, Fernandez Mariana, Fowler Jessica, Paner-Straseviciute Agne, Kim Nina, Doyle Margaret, Marshall Alexander, Cheadle Jessica, Keeping Sam, Liu Jane Jijun
Section of Hematology/Oncology, University of Chicago Medical Center, Chicago, IL 60637, USA.
Division of Hematology/Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
Cancers (Basel). 2025 Apr 5;17(7):1235. doi: 10.3390/cancers17071235.
: Teclistamab (TEC) is the first B-cell maturation antigen-directed bispecific antibody approved in 2022 by the European Medicines Agency and Food and Drug Administration for triple-class exposed relapsed/refractory multiple myeloma (RRMM). : As TEC is increasingly used in real-world (RW) settings, this study seeks to gather existing RW evidence on effectiveness, safety, healthcare resource utilization, and clinical practices associated with TEC. : A systematic literature review was performed to identify RW observational studies of TEC-treated adults with RRMM from 2023 to June 2024. : Sixty-one records representing 41 unique studies were included; sample sizes ranged from 8 to 572 patients. Where reported, median follow-up ranged from 2.3 to 33.6 months, and >65% of the patients would have been ineligible for the pivotal trial of TEC (MajesTEC-1) in all but one study. In eight studies with ≥50 patients and ≥3 months follow-up, overall response rates were 59-66% and cytokine release syndrome (CRS) rates were 18-64%. Tocilizumab use for CRS management was reported in 14 studies, with two indicating CRS rates of 13% and 26% when used prophylactically. Survival and infection outcomes showed wide variability due to short follow-up in most studies. : Overall, early RW effectiveness and safety outcomes of TEC were comparable to findings from MajesTEC-1.
泰吉华（TEC）是首个针对B细胞成熟抗原的双特异性抗体，于2022年获欧洲药品管理局和美国食品药品监督管理局批准用于治疗接受过三类药物治疗的复发/难治性多发性骨髓瘤（RRMM）。随着泰吉华在现实世界（RW）环境中越来越多地被使用，本研究旨在收集有关泰吉华的有效性、安全性、医疗资源利用以及临床实践的现有现实世界证据。进行了一项系统的文献综述，以确定2023年至2024年6月期间对接受泰吉华治疗的RRMM成年患者进行的现实世界观察性研究。纳入了代表41项独特研究的61条记录；样本量从8名至572名患者不等。在有报告的情况下，中位随访时间为2.3至33.6个月，除一项研究外，在所有研究中超过65%的患者不符合泰吉华关键试验（MajesTEC-1）的入组标准。在八项有≥50名患者且随访≥3个月的研究中，总缓解率为59%-66%，细胞因子释放综合征（CRS）发生率为18%-64%。14项研究报告了使用托珠单抗治疗CRS，其中两项表明预防性使用时CRS发生率分别为13%和26%。由于大多数研究的随访时间较短，生存和感染结果显示出很大的变异性。总体而言，泰吉华的早期现实世界有效性和安全性结果与MajesTEC-1的研究结果相当。
