Efficacy and safety blinatumomab in chinese adults with Ph-negative relapsed/refractory B-cell Precursor acute lymphoblastic leukemia: A multicenter open-label single-arm China registrational study
单位:[1]Southern Med Univ, Nanfang Hosp, Guangzhou, Peoples R China[2]Henan Canc Hosp, Zhengzhou, Peoples R China河南省肿瘤医院[3]Zhejiang Univ, Affiliated Hosp 1, Coll Med, Hangzhou, Peoples R China浙江大学医学院附属第一医院[4]Sichuan Univ, West China Hosp, Chengdu, Peoples R China四川大学华西医院[5]Peking Univ Int Hosp, Beijing, Peoples R China[6]Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Wuhan, Peoples R China华中科技大学同济医学院附属同济医院[7]Anhui Prov Hosp, Hefei, Peoples R China[8]China Med Univ, Hosp 1, Shenyang, Peoples R China[9]Cent South Univ, Xiangya Hosp, Changsha, Peoples R China[10]Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Guangzhou, Peoples R China中山大学附属第二医院[11]First Hosp Jilin Univ, Jilin, Jilin, Peoples R China[12]Fujian Med Univ Union Hosp, Fuzhou, Fujian, Peoples R China[13]Xi An Jiao Tong Univ, Affiliated Hosp 2, Xian, Shaanxi, Peoples R China[14]Guangdong Acad Med Sci, Guangdong Prov Peoples Hosp, Dept Hematol, Guangzhou, Peoples R China广东省人民医院[15]Chinese People Liberat Army Gen Hosp, Beijing, Peoples R China[16]Zhejiang Univ, Coll Med, Affiliated Hosp 2, Hangzhou, Zhejiang, Peoples R China[17]Peking Univ Third Hosp, Beijing, Peoples R China[18]Peking Union Med Coll Hosp, Beijing, Peoples R China[19]Soochow Univ, Affiliated Hosp 1, Suzhou, Jiangsu, Peoples R China[20]Fudan Univ, Huashan Hosp, Shanghai, Peoples R China[21]Amgen Inc, Global Biostat Sci, Thousand Oaks, CA 91320 USA[22]Amgen Inc, Global Dev, Thousand Oaks, CA 91320 USA[23]Amgen China, Shanghai, Peoples R China[24]Amgen Res Munich GmbH, Global Dev, Munich, Germany[25]Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol & Blood Dis Hosp, Tianjin, Peoples R China
Objectives: The prognosis for adults with relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (BCP-ALL) is poor. Blinatumomab is a CD3/CD19-directed BITE (R) (bispecific T-cell engager) molecule approved globally for the treatment of BCP-ALL in adults and children. This multicenter open-label single-arm China registrational study evaluated the safety, efficacy, and pharmacokinetics of blinatumomab in Chinese adults with Philadelphia chromosome-negative (Ph-) R/R BCP-ALL (NCT03476239). Methods: Patients aged >= 18 years were treated with up to 5 cycles of blinatumomab. The primary objective was to evaluate the hematological response rate (complete remission/ complete remission with partial hematological recovery [CR/CRh]) within 2 cycles of blinatumomab. Results: At the interim analysis (April 12, 2019), 90 patients (median age 31.5 years [range: 1874]; 53.3% female; 77.8% with bone marrow blasts >= 50% at study entry) were enrolled at 23 study centers in China and had received blinatumomab. As of data cutoff, 43 patients (47.8%) continued the study. The CR/CRh rate within 2 cycles of blinatumomab was 45.6% (41/90 [CR, 37; CRh, 4]; 95% CI: 35.0-56.4). Median overall survival was 9.2 months (95% CI: 6.5-11.7); median relapse-free survival was 4.3 months (95% CI: 3.2-9.4). Mean serum concentration at steady-state and systemic clearance of blinatumomab in Chinese patients were within the range reported in adults from global clinical trials. No new safety risks were identified in Chinese patients. Conclusions: The efficacy and safety of blinatumomab in these heavily pre-treated Chinese patients with Ph- R/R BCP-ALL is comparable to that for patients within global clinical trials.
第一作者单位:[1]Southern Med Univ, Nanfang Hosp, Guangzhou, Peoples R China
通讯作者:
推荐引用方式(GB/T 7714):
Zhou Hongsheng,Yin Qingsong,Jin Jie,et al.Efficacy and safety blinatumomab in chinese adults with Ph-negative relapsed/refractory B-cell Precursor acute lymphoblastic leukemia: A multicenter open-label single-arm China registrational study[J].HEMATOLOGY.2022,27(1):917-927.doi:10.1080/16078454.2022.2111992.
APA:
Zhou, Hongsheng,Yin, Qingsong,Jin, Jie,Liu, Ting,Cai, Zhen...&Wang, Jianxiang.(2022).Efficacy and safety blinatumomab in chinese adults with Ph-negative relapsed/refractory B-cell Precursor acute lymphoblastic leukemia: A multicenter open-label single-arm China registrational study.HEMATOLOGY,27,(1)
MLA:
Zhou, Hongsheng,et al."Efficacy and safety blinatumomab in chinese adults with Ph-negative relapsed/refractory B-cell Precursor acute lymphoblastic leukemia: A multicenter open-label single-arm China registrational study".HEMATOLOGY 27..1(2022):917-927