Abstract：
Teclistamab is a B cell maturation antigen (BCMA)-directed bispecific antibody approved for relapsed/refractory multiple myeloma (RRMM) on the basis of the phase I/II MajesTEC-1 trial. Here we report clinical outcomes with standard-of-care teclistamab in a real-world RRMM population. A total of 106 patients from 5 academic centers who received teclistamab from August 2022 to August 2023 were included in this retrospective analysis, 83% of whom would have been considered ineligible for the MajesTEC-1 trial. All patients were triple-class exposed, 64% were penta-class refractory, and 53% had received prior BCMA-directed therapy. Cytokine release syndrome was observed in 64% of patients, and only 1 event was grade ≥3, whereas immune effector cell-associated neurotoxicity syndrome was observed in 14% of patients (3 events were grade 3 or 4). One-third (31%) of patients experienced at least 1 infection, with nearly half of these infections graded as severe (grade ≥3). The overall response rate (ORR) was 66%, and the complete or better response rate was 29%. The ORR was 47% for patients with extramedullary disease (EMD), 59% for patients with prior BCMA-directed therapy exposure, and 68% for patients with penta-refractory disease. At a median follow-up of 3.8 months, the median progression-free survival (PFS) was 5.4 months (95% CI, 3.4 months to not reached), while median overall survival was not reached. Patients with Eastern Cooperative Oncology Group Performance Status ≥2, EMD, and age ≤70 years had inferior PFS on multivariable analysis. Our study demonstrates reasonable safety and good efficacy of teclistamab in patients with RRMM treated in a real-world setting.
摘要：
Teclistamab是一种针对B细胞成熟抗原（BCMA）的双特异性抗体，在I/IIMajesTEC-1期试验的基础上被批准用于复发性难治性多发性骨髓瘤（RRMM）。在这里，我们报告了在现实世界的RRMM人群中使用标准治疗teclistamab的临床结局.从2022年8月8日至2023年8月8日，共有来自五个学术中心的106名患者接受了teclistamab，纳入了这项回顾性分析；其中83％的患者被认为不符合MajesTec-1试验的条件。所有患者都是三重暴露的，64%是五级耐火材料，53%曾接受过BCMA指导的治疗。在64％的患者中观察到细胞因子释放综合征，只有一个事件≥3级，而在14％的患者中观察到免疫效应细胞相关的神经毒性综合征（三个事件为3-4级）。三分之一（31%）的患者至少经历过一次感染，这些感染中有近一半被评为严重（≥3级）。总反应率（ORR）和完全或更好的反应率分别为66％和29％，分别。ORR为47%,59%和68%为髓外疾病（EMD）患者，先前的BCMA定向治疗，和五难治性疾病，分别。在中位随访3.8个月时，中位无进展生存期（PFS）为5.4个月（95%CI，3.4个月-未达到），而未达到中位总生存期.东部肿瘤协作组患者表现状态≥2，EMD，在多变量分析中，年龄≤70岁的PFS较差。我们的研究表明，在现实环境中接受RRMM治疗的患者中，teclistamab具有合理的安全性和良好的疗效。
