Efficacy and safety of blinatumomab in Chinese adults with Ph-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia: A multicenter open-label single-arm China registrational study
机构：[a]Nanfang Hospital, Southern Medical University, Guangzhou, China[b]Henan Cancer Hospital, Zhengzhou, China河南省肿瘤医院[c]The First Affiliated Hospital, College of Medicine, Zhejiang University College of Medicine, Hangzhou, China浙江大学医学院附属第一医院[d]West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[e]Peking University International Hospital, Beijing, China[f]Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属同济医院[g]Anhui Provincial Hospital, Hefei, China[h]The First Hospital of China Medical University, Shenyang, China[i]Xiangya Hospital Central South University, Changsha, China[j]Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China中山大学附属第二医院[k]The First Hospital of Jilin University, Jilin, China[l]Fujian Medical University Union Hospital, Fujian, China[m]The Second Affiliated Hospital of Xian Jiaotong University, Shaanxi, China[n]Department of Hematology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China[o]Chinese People Liberation Army General Hospital, Beijing, China[p]The Second Affiliated Hospital Zhejiang University College of Medicine, Zhejiang, China[q]Peking University Third Hospital, Beijing, China[r]Peking Union Medical College Hospital, Beijing, China[s]The First Affiliated Hospital of Soochow University, Jiangsu, China[t]Huashan Hospital Affiliated to Fudan University, Shanghai, China[u]Global Biostatistical Sciences, Amgen Inc., Thousand Oaks, CA, USA[v]Global Development, Amgen Inc., Thousand Oaks, CA, USA[w]Amgen China, Shanghai, People’s Republic of China[x]Global Development, Amgen Research (Munich) GmbH, Munich, Germany[y]Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People’s Republic of China
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® (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).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.At the interim analysis (April 12, 2019), 90 patients (median age 31.5 years [range: 18-74]; 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.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.
第一作者机构：[a]Nanfang Hospital, Southern Medical University, Guangzhou, China
通讯作者：
推荐引用方式(GB/T 7714)：
Hongsheng Zhou,Qingsong Yin,Jie Jin,et al.Efficacy and safety of 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：
Hongsheng Zhou,Qingsong Yin,Jie Jin,Ting Liu,Zhen Cai...&Jianxiang Wang.(2022).Efficacy and safety of 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：
Hongsheng Zhou,et al."Efficacy and safety of 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
