在中国MajesTEC-1队列的复发/难治性多发性骨髓瘤患者中，替西妥单抗的疗效、安全性和药代动力学。
Efficacy, safety, and pharmacokinetics of teclistamab in Chinese patients with relapsed/refractory multiple myeloma from the China cohort of MajesTEC-1.
作者信息
Cai Zhen, Xia Zhongjun, He Ai-Li, Dong Yu-Jun, Wang Yafei, Liao Aijun, Song Yang, Song Mm Juanjuan, Uhlar Clarissa, Chastain Katherine, Watkins Latisha, Luo Xinchao, Huang Lin, Niu Zhuolu, Quijano Cardé Natalia A, Guo Yue, Xu Hongmei, Verona Raluca I, Zhou Longen, Li Jingyun, Fu Weijun, Niu Ting, Du Juan
机构信息
First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, Zhejiang, China.
Sun Yat-Sen University Cancer Center, Guangzhou, China.
出版信息
Cancer. 2025 Jan 1;131(1):e35665. doi: 10.1002/cncr.35665. Epub 2024 Dec 11.
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.
引言
替雷利珠单抗是首个获批用于治疗经三类药物治疗的复发/难治性多发性骨髓瘤的靶向B细胞成熟抗原的双特异性抗体，在关键的MajesTEC-1队列研究（NCT03145181/NCT04557098）中显示出深度、持久的疗效，且安全性可控。本文报告了MajesTEC-1中国队列研究的疗效、安全性和药代动力学情况。
方法
患者在递增剂量后每周皮下注射1.5mg/kg替雷利珠单抗；若持续有反应，患者可改为较低频率给药。
结果
在中国队列研究中（N = 26；中位年龄66岁；中位既往治疗线数5线），中位随访15个月，总缓解率、非常好的部分缓解或更好的缓解率以及完全缓解或更好的缓解率（≥CR）分别为76.9%、76.9%和57.7%。首次缓解和≥CR的中位时间分别为1.4个月和6.3个月；在有≥CR且有可用微小残留病（MRD）样本的患者中，14/15（93.3%）患者达到MRD阴性。缓解持续时间、无进展生存期和总生存期的中位值均未达到；12个月时的缓解持续率、无进展生存率和总生存率分别为78.5%、68.0%和83.5%。安全性与关键队列一致。虽然96.2%的患者发生感染，但随着时间推移感染发生率下降，有6名患者感染持续时间超过12至18个月。没有因不良事件而停药的情况，也没有剂量减少的情况。10名患者改为较低频率给药。替雷利珠单抗的血清浓度与关键队列一致，平均药代动力学曲线略低。
结论
替雷利珠单抗在中国队列研究中显示出与关键队列一致的疗效和安全性，支持替雷利珠单抗作为中国经三类药物治疗的复发/难治性多发性骨髓瘤的一种有前景的治疗选择。
Zotero 插件