Teclistamab is a B-cell maturation antigen (BCMA)–directed bispecific antibody approved for the treatment of patients with triple-class exposed relapsed/refractory multiple myeloma (R/RMM). In the phase 1/2 MajesTEC-1 study, a cohort of patients who had prior BCMA-targeted therapy (antibody-drug conjugate [ADC] or chimeric antigen receptor T-cell [CAR-T] therapy) was enrolled to explore teclistamab in patients previously exposed to anti-BCMA treatment. At a median follow-up of 28.0 months (range, 0.7-31.1), 40 patients with prior BCMA-targeted therapy had received subcutaneous 1.5 mg/kg weekly teclistamab. The median prior lines of treatment was 6 (range, 3-14). Prior anti-BCMA therapy included ADC (n = 29), CAR-T (n = 15), or both (n = 4). The overall response rate was 52.5%; 47.5% of patients achieved very good partial response or better, and 30.0% achieved complete response or better. The median duration of response was 14.8 months, the median progression-free survival was 4.5 months, and the median overall survival was 15.5 months. The most common treatment-emergent adverse events (TEAEs) were neutropenia, infections, cytokine release syndrome, and anemia; cytopenias and infections were the most common grade ≥3 TEAEs. Infections occurred in 28 patients (70.0%; maximum grade 3/4, n = 13 [32.5%]; grade 5, n = 4 [10%]). Before starting teclistamab, baseline BCMA expression and immune characteristics were unaffected by prior anti-BCMA treatment. The MajesTEC-1 trial cohort C results demonstrate favorable efficacy and safety of teclistamab in patients with heavily pretreated R/RMM and prior anti-BCMA treatment. This trial was registered at www.ClinicalTrials.gov as #NCT03145181 and #NCT04557098.

中文翻译：

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teclistamab 在 BCMA 靶向治疗后复发/难治性多发性骨髓瘤患者中的疗效和安全性


Teclistamab 是一种 B 细胞成熟抗原 （BCMA） 定向双特异性抗体，被批准用于治疗三类暴露复发/难治性多发性骨髓瘤 （R/RMM） 患者。在 1/2 期 MajesTEC-1 研究中，招募了一组既往接受过 BCMA 靶向治疗（抗体-药物偶联物 [ADC] 或嵌合抗原受体 T 细胞 [CAR-T] 治疗）的患者，以探索 teclistamab 在既往接受过抗 BCMA 治疗的患者中的应用。在中位随访 28.0 个月 （范围，0.7-31.1） 时，40 名既往接受过 BCMA 靶向治疗的患者每周接受 1.5 mg/kg 的 teclistamab。既往治疗的中位数为 6 线 （范围，3-14）。既往抗 BCMA 治疗包括 ADC （n = 29） 、 CAR-T （n = 15） 或两者 （n = 4）。总缓解率为 52.5%;47.5% 的患者达到非常好的部分缓解或更好，30.0% 的患者达到完全缓解或更好。中位缓解持续时间为 14.8 个月，中位无进展生存期为 4.5 个月，中位总生存期为 15.5 个月。最常见的治疗中出现的不良事件 （TEAE） 是中性粒细胞减少、感染、细胞因子释放综合征和贫血;血细胞减少和感染是最常见的 ≥3 级 TEAE。感染发生在 28 例患者 （70.0%;最大 3/4 级，n = 13 [32.5%];5 级，n = 4 [10%]）。在开始使用 teclistamab 之前，基线 BCMA 表达和免疫特性不受既往抗 BCMA 治疗的影响。MajesTEC-1 试验队列 C 结果表明，teclistamab 在既往接受过大量治疗的 R/RMM 和既往抗 BCMA 治疗患者中具有良好的疗效和安全性。该试验在 www.ClinicalTrials.gov 注册为 #NCT03145181 和 #NCT04557098。