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

作者：Hongsheng Zhou, Qingsong Yin, Jie Jin, Ting Liu, Zhen Cai, Bin Jiang, Dengju Li, Zimin Sun, Yan Li, Yanjuan He, Liping Ma, Sujun Gao, Jianda Hu, Aili He, Xin Du, Dai‐Hong Liu, Xiaohong Zhang, Xiaoyan Ke, Junling Zhuang, Yue Han, Xiaoqin Wang, Yuqi Chen, Paul Gordon, Yu Dong, Gerhard Zugmaier, Jianxiang Wang · 发表于：Hematology · 年份：2022 · DOI：10.1080/16078454.2022.2111992 · 被引用次数：11 · 研究领域：Acute Lymphoblastic Leukemia research、CAR-T cell therapy research、Chronic Myeloid Leukemia Treatments

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® (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: 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...