Background: 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).Objectives: 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.Methods: A systematic literature review was performed to identify RW observational studies of TEC-treated adults with RRMM from 2023 to June 2024.Results: 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.Conclusions: Overall, early RW effectiveness and safety outcomes of TEC were comparable to findings from MajesTEC-1.
背景：Teclistamab（TEC）是首个靶向B细胞成熟抗原的双特异性抗体，于2022年获得欧洲药品管理局和美国食品药品监督管理局批准，用于治疗三重暴露的复发/难治性多发性骨髓瘤（RRMM）。目的：随着TEC在真实世界（RW）中的应用日益广泛，本研究旨在收集关于TEC有效性、安全性、医疗资源利用及相关临床实践的现有真实世界证据。方法：通过系统性文献回顾，识别2023年至2024年6月期间针对TEC治疗成人RRMM的真实世界观察性研究。结果：共纳入61篇文献，涉及41项独立研究；样本量范围为8至572例患者。在报告随访时间的研究中，中位随访时间为2.3至33.6个月，除一项研究外，所有研究中超过65%的患者不符合TEC关键临床试验（MajesTEC-1）的入组标准。在8项样本量≥50例且随访时间≥3个月的研究中，总体缓解率为59%至66%，细胞因子释放综合征（CRS）发生率为18%至64%。14项研究报告了使用托珠单抗管理CRS的情况，其中两项研究显示预防性使用时CRS发生率分别为13%和26%。由于大多数研究随访时间较短，生存和感染结局存在较大差异。结论：总体而言，TEC在真实世界中的早期有效性和安全性结果与MajesTEC-1试验的发现具有可比性。
肿瘤(癌症)患者之家