Subcutaneous daratumumab in Chinese patients with relapsed or refractory multiple myeloma:an open-label,multicenter,phase 1 study(MMY1010)

作     者：Gang An Zheng Ge Hongmei Jing Jing Liu Guoping Yang Ru Feng Zhongyuan Xu Ming Qi Jianping Wang Juanjuan Song Wei Zhou Binbin Sun Dian Zhu Xi Chen Canchan Cui Lugui Qiu 

作者机构：National Clinical Research Center for Hematological DisordersState Key Laboratory of Experimental HematologyInstitute of Hematology and Blood Diseases HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeTianjin 300020China Department of HematologyZhongda Hospital Southeast UniversityNanjing 210009China Peking University Third HospitalBeijing 100191China Department of HematologyThe Third Xiangya Hospital of Central South UniversityChangsha 410013China Department of HematologyNanfang Hospital of Southern Medical UniversityGuangzhou 510515China Phase 1 Clinical Trial DepartmentNanfang Hospital of Southern Medical UniversityGuangzhou 510515China Janssen Research&DevelopmentLLCSpring HousePA 19477USA Janssen Research&DevelopmentLLCBeijing 100025China Janssen Research&DevelopmentLLCShanghai 200231Chin 

出 版 物：《Blood Science》 (血液科学（英文）)

年 卷 期：2024年第6卷第3期

页      面：42-47页

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：Janssen Research and Development  JRD 

主　　题：Chinese Daratumumab Multiple myeloma Pharmacokinetic Relapse/refractory Safety Subcutaneous 

摘      要：Despite recent progress in multiple myeloma(MM)treatments,most patients will relapse and require additional *** daratumumab,a human IgGκmonoclonal antibody targeting CD38,has shown good efficacy in the treatment of MM.A subcutaneous version of daratumumab was formulated to reduce the burden of intravenous *** aimed to investigate the efficacy and safety of subcutaneous daratumumab in Chinese patients with relapsed/refractory MM based on the demonstrated noninferiority of subcutaneous daratumumab to intravenous daratumumab,with a shorter administration time and reduced infusion-related reaction rate in global *** phase 1,multicenter study(MMY1010;*** Identifier:NCT04121260)evaluated subcutaneous daratumumab in Chinese patients with relapsed/refractory MM after 1 prior line(n=1)or≥2 prior lines(n=20)of therapy,including a proteasome inhibitor and an immunomodulatory *** endpoints were pharmacokinetics and ***(standard deviation)maximum trough concentration of daratumumab was 826(335)μg/mL,which was consistent with prior studies of subcutaneous daratumumab and intravenous *** was consistent with safety profiles observed in other daratumumab studies,with no new safety concerns *** of infusion-related reactions and injection-site reactions were low and consistent with other subcutaneous daratumumab *** a median follow-up of 7.5 months,the overall response rate was 57.1%,with a very good partial response or better rate of 38.1%and complete response or better rate of 19.0%.Our results demonstrate a favorable benefit/risk profile of subcutaneous daratumumab in Chinese patients with relapsed/refractory MM,potentially impacting clinical administration of daratumumab in this population.