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.

Abstract

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 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.

• Authors: 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, Daihong Liu, Xiaohong Zhang, Xiaoyan Ke, Junling Zhuang, Yue Han, Xiaoqin Wang, Yuqi Chen, Paul Gordon, Dong Yu, Gerhard Zugmaier, Jianxiang Wang
• Journal: Hematology (Amsterdam, Netherlands) (Hematology) Vol. 27 Issue 1 Pg. 917-927 (Dec 2022) ISSN: 1607-8454 [Electronic] England
• PMID: 36000952 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Antibodies, Bispecific
• Antineoplastic Agents
• blinatumomab

Topics

• Acute Disease
• Adult
• Antibodies, Bispecific (adverse effects)
• Antineoplastic Agents (therapeutic use)
• Child
• China
• Female
• Humans
• Lymphoma, B-Cell
• Male
• Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma (drug therapy)