文章：

特立妥单抗治疗复发难治性多发性骨髓瘤：多中心真实世界研究

Teclistamab in relapsed refractory multiple myeloma: multi-institutional real-world study

原文发布日期：2024-03-05

DOI: 10.1038/s41408-024-01003-z

类型: Article

开放获取: 是

英文摘要：

The objective of our study was to report real-world data on the safety and efficacy of standard-of-care teclistamab in patients with relapsed/refractory multiple myeloma (MM). This is a multi-institutional retrospective cohort study and included all consecutive patients that received at least one dose of teclistamab up until August 2023. One hundred and ten patients were included, of whom, 86% had triple-class refractory disease, 76% penta-refractory disease, and 35% had prior exposure to B-cell maturation antigen (BCMA)-targeting therapies. The overall response rate (ORR) in our cohort was 62%, with a ≥ very good partial remission (VGPR) rate of 51%. The ORR in patients with and without prior BCMA-targeted therapies was 54% vs 67%, respectively (p = 0.23). At a median follow-up of 3.5 months (range, 0.39–10.92), the estimated 3 month and 6 month progression free survival (PFS) was 57% (95% CI, 48%, 68%) and 52% (95% CI, 42%, 64%) respectively. The incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) was 56% and 11% respectively, with grade ≥3 CRS and ICANS noted in 3.5% and 4.6% of patients respectively. 78 unique infections were diagnosed in 44 patients, with the incidence of all-grade and grade ≥3 infections being 40% vs 26% respectively. Primary prophylaxis with intravenous immunoglobulin (IVIG) was associated with a significantly lower infection risk on multivariate analysis (Hazard ratio [HR] 0.33; 95% CI 0.17, 0.64; p = 0.001).
 

摘要翻译： 

本研究旨在报告复发/难治性多发性骨髓瘤患者接受标准治疗药物teclistamab在真实世界中的安全性与有效性数据。这是一项多机构回顾性队列研究，纳入了截至2023年8月所有至少接受过一剂teclistamab治疗的连续患者。共纳入110例患者，其中86%为三重难治性疾病，76%为五重难治性疾病，35%曾接受过靶向B细胞成熟抗原治疗。本队列的总体缓解率为62%，达到≥非常好部分缓解的比例为51%。既往接受与未接受过BCMA靶向治疗患者的总体缓解率分别为54%和67%（p=0.23）。中位随访3.5个月（范围0.39-10.92个月）时，预估的3个月和6个月无进展生存率分别为57%（95% CI 48%-68%）和52%（95% CI 42%-64%）。细胞因子释放综合征和免疫效应细胞相关神经毒性综合征的发生率分别为56%和11%，其中≥3级CRS和ICANS发生率分别为3.5%和4.6%。44例患者共发生78次独立感染事件，全级别感染与≥3级感染发生率分别为40%和26%。多变量分析显示，静脉注射免疫球蛋白的初级预防与显著降低的感染风险相关（风险比0.33；95% CI 0.17-0.64；p=0.001）。

原文链接：

Teclistamab in relapsed refractory multiple myeloma: multi-institutional real-world study