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Efficacy and safety of teclistamab in patients with relapsed/refractory multiple myeloma after BCMA-targeting therapies

医学 中性粒细胞减少症 内科学 不利影响 发热性中性粒细胞减少症 多发性骨髓瘤 胃肠病学 细胞因子释放综合征 耐火材料(行星科学) 贫血 外科 肿瘤科 毒性 免疫疗法 嵌合抗原受体 癌症 物理 天体生物学
作者
Cyrille Touzeau,Amrita Krishnan,Philippe Moreau,Aurore Perrot,Saad Z. Usmani,Salomon Manier,Michèle Cavo,Carmen Martínez Chamorro,Ajay K. Nooka,Thomas G. Martin,Lionel Karlin,Xavier Leleu,Nizar J. Bahlis,Britta Besemer,Lixia Pei,Sarah Stein,Shun Xin Wang Lin,Danielle Trancucci,Raluca Verona,Suzette Girgis
出处
期刊:Blood [Elsevier BV]
卷期号:144 (23): 2375-2388 被引量:38
标识
DOI:10.1182/blood.2023023616
摘要

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.
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