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 

机构地区：[1]National Clinical Research Center for Hematological Disorders,State Key Laboratory of Experimental Hematology,Institute of Hematology and Blood Diseases Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Tianjin 300020,China [2]Department of Hematology,Zhongda Hospital Southeast University,Nanjing 210009,China [3]Peking University Third Hospital,Beijing 100191,China [4]Department of Hematology,The Third Xiangya Hospital of Central South University,Changsha 410013,China [5]Department of Hematology,Nanfang Hospital of Southern Medical University,Guangzhou 510515,China [6]Phase 1 Clinical Trial Department,Nanfang Hospital of Southern Medical University,Guangzhou 510515,China [7]Janssen Research&Development,LLC,Spring House,PA 19477,USA [8]Janssen Research&Development,LLC,Beijing 100025,China [9]Janssen Research&Development,LLC,Shanghai 200231,Chin

出　　处：《Blood Science》2024年第3期42-47,共6页血液科学（英文）

摘　　要：Despite recent progress in multiple myeloma(MM)treatments,most patients will relapse and require additional treatment.Intravenous 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 infusions.We 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 studies.This phase 1,multicenter study(MMY1010;ClinicalTrials.gov 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 drug.Primary endpoints were pharmacokinetics and safety.Mean(standard deviation)maximum trough concentration of daratumumab was 826(335)μg/mL,which was consistent with prior studies of subcutaneous daratumumab and intravenous daratumumab.Safety was consistent with safety profiles observed in other daratumumab studies,with no new safety concerns identified.Incidences of infusion-related reactions and injection-site reactions were low and consistent with other subcutaneous daratumumab studies.At 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.

关 键 词：Chinese Daratumumab Multiple myeloma PHARMACOKINETIC Relapse/refractory Safety SUBCUTANEOUS 

分 类 号：R733.3[医药卫生—肿瘤]