1. Efficacy, safety, and pharmacokinetics of teclistamab in Chinese patients with relapsed/refractory multiple myeloma from the China cohort of MajesTEC-1.
- Author
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Cai Z, Xia Z, He AL, Dong YJ, Wang Y, Liao A, Song Y, Song Mm J, Uhlar C, Chastain K, Watkins L, Luo X, Huang L, Niu Z, Quijano Cardé NA, Guo Y, Xu H, Verona RI, Zhou L, Li J, Fu W, Niu T, and Du J
- Subjects
- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, B-Cell Maturation Antigen, China epidemiology, Cohort Studies, East Asian People, Neoplasm Recurrence, Local drug therapy, Treatment Outcome, Antibodies, Bispecific pharmacokinetics, Antibodies, Bispecific administration & dosage, Antibodies, Bispecific adverse effects, Antibodies, Bispecific therapeutic use, Multiple Myeloma drug therapy, Multiple Myeloma pathology
- Abstract
Introduction: Teclistamab, the first approved B-cell maturation antigen-directed bispecific antibody for treatment of triple-class exposed relapsed/refractory multiple myeloma, demonstrated deep, durable responses with a manageable safety profile in the pivotal MajesTEC-1 cohort (NCT03145181/NCT04557098). Efficacy, safety, and pharmacokinetics from the MajesTEC-1 China cohort are reported., Methods: Patients received teclistamab 1.5 mg/kg subcutaneously weekly after step-up dosing; patients could switch to less frequent dosing with continued response., Results: In the China cohort (N = 26; median age, 66 years; median prior lines of therapy, 5) 15-month median follow-up, overall response rates, very good partial response or better, and complete response or better (≥CR) were 76.9%, 76.9%, and 57.7%, respectively. Median time to first response and ≥CR were 1.4 and 6.3 months, respectively; among patients with ≥CR and have available MRD samples, MRD negativity was achieved in 14/15 (93.3%) patients. Median duration of response, progression-free survival, and overall survival were not reached; 12-month duration of response, progression-free survival, and overall survival rates were 78.5%, 68.0%, and 83.5%, respectively. The safety profile was consistent with the pivotal cohort. Although infections occurred in 96.2% of patients, incidence decreased over time with six patients experiencing infections for >12 to 18 months. There were no discontinuations because of adverse events and no dose reductions. Ten patients switched to less frequent dosing. Teclistamab serum concentrations were consistent with the pivotal cohort, with a slightly lower mean pharmacokinetics profile., Conclusions: Teclistamab demonstrated efficacy and safety profiles in the China cohort consistent with the pivotal cohort, supporting teclistamab as a promising treatment option for triple-class exposed relapsed/refractory multiple myeloma in China., (© 2024 The Author(s). Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.)
- Published
- 2025
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