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

作者：Zhou, Hongsheng; Yin, Qingsong; Jin, Jie; Liu, Ting; Cai, Zhen; Jiang, Bin; Li, Dengju; Sun, Zimin; Li, Yan; He, Yanjuan; Ma, Liping; Gao, Sujun; Hu, Jianda; He, Aili; Du, Xin; Liu, Daihong; Zhang, Xiaohong; Ke, Xiaoyan; Zhuang, Junling; Han, Yue; Wang, Xiaoqin; Chen, Yuqi; Gordon, Paul; Yu, Dong; Zugmaier, Gerhard; Wang, Jianxiang^*

来源：Hematology, 2022, 27(1): 917-927.

DOI：10.1080/16078454.2022.2111992

• Acute lymphoblastic leukemia
• relapsed/refractory
• BiTE (R) molecule
• blinatumomab
• Chinese adults

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.

• 单位
  中山大学; 1; 四川大学; 华中科技大学; 吉林大学; 复旦大学; 浙江大学; 中国医学科学院北京协和医院; 北京大学; 苏州大学; 中国医科大学; 南方医科大学; 西安交通大学; 广东省人民医院