What is the role of blinatumomab (Blincyto) in the treatment of acute lymphoblastic leukemia (ALL)?

Updated: Mar 23, 2021
  • Author: Karen Seiter, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Blinatumomab (Blincyto), a bispecific T-cell engager (BiTE) antibody, was approved by the FDA in December 2014 for Ph- relapsed or refractory B-cell precursor ALL. BiTE antibodies enable CD3-positive T cells to recognize and eliminate CD19-positive ALL blasts. Approval of blinatumomab was based on results of a phase 2, multicenter, single-arm open-label study in which 77 (41.6%) of 185 adult patients achieved complete remission or complete remission with partial hematologic recovery within 2 cycles of treatment with blinatumomab. [76, 77]

A phase III trial in 405 adults with heavily pretreated B-cell precursor ALL found that treatment with blinatumomab (n = 271) resulted in significantly longer overall survival than treatment with chemotherapy (n = 134). Event-free survival estimates at 6 months were 31% with blinatumomab versus 12% with chemotherapy, and median duration of remission was 7.3 vs. 4.6 months, respectively. A total of 24% of the patients in each treatment group underwent allogeneic HSCT. [78]

Blinatumomab was also granted accelerated approval for the treatment of CD19-positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) ≥ 0.1% in adults and children. Efficacy was evaluated in the open-label, multicenter, single-arm BLAST study that enrolled 116 adult patients with B-precursor ALL in hematologic complete remission after at least 3 intensive chemotherapy treatments and with MRD ≥10-3. In BLAST, 78% of patients had a complete MRD response, 98% of which occurred within the first treatment cycle. [79]

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