Blinatumomab: A first-in-class bispecific T-cell engager for precursor B-cell acute lymphoblastic leukemia Journal Article
| Authors: | Buie, L. W.; Pecoraro, J. J.; Horvat, T. Z.; Daley, R. J. |
| Article Title: | Blinatumomab: A first-in-class bispecific T-cell engager for precursor B-cell acute lymphoblastic leukemia |
| Abstract: | Objective: To review the clinical pharmacology, efficacy, and safety of blinatumomab for the treatment of pediatric and adult precursor B-cell acute lymphoblastic leukemia (B-ALL). Data Sources: A literature search of EMBASE (1947 to April 2015), Medline (1946 to April 2015), PubMed (1996 to April 2015), the U.S. National Institutes of Health Clinicaltrials.gov, the Food and Drug Administration, and relevant meeting abstracts was conducted using the terms blinatumomab, BiTE, bispecific T-cell engager, MT103, MEDI-538, and Blincyto. Study Selection/Data Extraction: Human and animal studies describing the pharmacology, pharmacokinetics and pharmacodynamics, efficacy, and safety of blinatumomab for precursor B-ALL were identified. Data Synthesis: Blinatumomab is a first-in-class bispecific T-cell engager (BiTE) antibody derived from a B-lineage specific antitumor mouse monoclonal antibody that binds to both CD19 of B-cells and CD3 of T-cells. A pivotal phase II trial demonstrated that response rates were high in a refractory or relapsed patient population, with 43% achieving complete remission (CR). Median relapse-free survival was 5.9 months for those with CR or CR with incomplete hematological recovery. Median overall survival was 6.1 months, and 60% of patients achieved minimal residual disease (MRD) negativity. The most common adverse events included pyrexia, neurological events, headache, febrile neutropenia, peripheral edema, nausea, hypokalemia, constipation, and anemia. Conclusions: Blinatumomab is a novel BiTE therapeutic monoclonal antibody that has shown promising results in patients with relapsed or refractory ALL or those achieving a CR with persistent MRD. Phase III clinical trials should define the optimal place in therapy of blinatumomab. © 2015, © The Author(s) 2015. |
| Keywords: | survival rate; constipation; fatigue; neutropenia; review; drug efficacy; drug safety; hypophosphatemia; cd3 antigen; t lymphocyte; interleukin 2; drug eruption; anemia; leukopenia; nausea; thrombocytopenia; vomiting; interleukin 10; food and drug administration; acute lymphoblastic leukemia; b lymphocyte; monoclonal antibody; alanine aminotransferase blood level; aspartate aminotransferase blood level; chill; febrile neutropenia; fever; hyperglycemia; lymphocytopenia; pneumonia; tumor lysis syndrome; alanine aminotransferase; aspartate aminotransferase; bilirubin; confusion; drug induced headache; hypokalemia; hypotension; survival time; tumor necrosis factor alpha; gamma interferon; drug mechanism; minimal residual disease; systematic review; brain disease; interleukin 6; peripheral edema; sepsis; medline; flu like syndrome; drug half life; aphasia; antigen binding; cytokine release; tremor; speech disorder; bilirubin blood level; cd19 antigen; embase; recurrence free survival; phase 2 clinical trial (topic); wheezing; disorientation; capillary leak syndrome; urinary excretion; consciousness disorder; clinical pharmacology; convulsion; blinatumomab; disseminated intravascular clotting; drug formulary; human; priority journal; bite; b-cell acute lymphoblastic leukemia; blincyto; concentration at steady-state |
| Journal Title: | Annals of Pharmacotherapy |
| Volume: | 49 |
| Issue: | 9 |
| ISSN: | 1060-0280 |
| Publisher: | Sage Publications |
| Date Published: | 2015-09-01 |
| Start Page: | 1057 |
| End Page: | 1067 |
| Language: | English |
| DOI: | 10.1177/1060028015588555 |
| PROVIDER: | scopus |
| PUBMED: | 26041811 |
| DOI/URL: | |
| Notes: | Export Date: 2 October 2015 -- Source: Scopus |
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