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Efficacy, safety, and pharmacokinetics of teclistamab in Chinese patients with relapsed/refractory multiple myeloma from the China cohort of MajesTEC-1

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机构: [1]First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, Zhejiang, China [2]Sun Yat‐Sen University Cancer Center, Guangzhou, China [3]The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China [4]Peking University First Hospital, Beijing, China [5]Tianjin Medical University Cancer Institute and Hospital, Tianjin, China [6]Shengjing Hospital of China Medical University, Shenyang, China [7]Janssen Research & Development, Beijing, China [8]Janssen Research & Development, Spring House, Pennsylvania, USA [9]Janssen Research & Development, Raritan, New Jersey, USA [10]Janssen Research & Development, Shanghai, China [11]Myeloma & Lymphoma Center, Shanghai Changzheng Hospital, Naval Medical University, Shanghai, China [12]West China Hospital, Sichuan University, Chengdu, Sichuan, China
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关键词: bispecific antibody (BsAb) relapsed/refractory multiple myeloma (RRMM) teclistamab triple‐class exposed (TCE)

摘要:
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.Patients received teclistamab 1.5 mg/kg subcutaneously weekly after step-up dosing; patients could switch to less frequent dosing with continued response.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.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.

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大类 | 2 区 医学
小类 | 2 区 肿瘤学
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第一作者机构: [1]First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, Zhejiang, China
通讯作者:
通讯机构: [11]Myeloma & Lymphoma Center, Shanghai Changzheng Hospital, Naval Medical University, Shanghai, China [*1]Department of Hematology, Myeloma & Lymphoma Center, Shanghai Changzheng Hospital, Naval Medical University, Shanghai, China.
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