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Safety and Efficacy of Teclistamab in Patients with Relapsed/Refractory Multiple Myeloma: A Real-World Experience

医学 内科学 耐火材料(行星科学) 多发性骨髓瘤 细胞因子释放综合征 临床试验 人口 肿瘤科 无进展生存期 挽救疗法 胃肠病学 外科 总体生存率 免疫疗法 化疗 癌症 嵌合抗原受体 物理 环境卫生 天体生物学
作者
Danai Dima,James A. Davis,Nausheen Ahmed,Xuefei Jia,Aishwarya Sannareddy,Hira Ghazal Shaikh,Leyla Osman Shune,Gurbakhash Kaur,Jack Khouri,Aimaz Afrough,Christopher Sun Strouse,Jonathan S. Lochner,Zahra Mahmoudjafari,Shahzad Raza,Jason Neil Valent,Larry Don Anderson,Faiz Anwer,Al-Ola A. Abdallah,Hamza Hashmi
出处
期刊:Biology of Blood and Marrow Transplantation [Elsevier BV]
卷期号:30 (3): 308.e1-308.e13 被引量:93
标识
DOI:10.1016/j.jtct.2023.12.016
摘要

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.
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