Abstract | OBJECTIVE: 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:
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Authors | Larry W Buie, Joshua J Pecoraro, Troy Z Horvat, Ryan J Daley |
Journal | The Annals of pharmacotherapy
(Ann Pharmacother)
Vol. 49
Issue 9
Pg. 1057-67
(Sep 2015)
ISSN: 1542-6270 [Electronic] United States |
PMID | 26041811
(Publication Type: Journal Article, Review)
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Copyright | © The Author(s) 2015. |
Chemical References |
- Antibodies, Bispecific
- Antineoplastic Agents
- blinatumomab
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Topics |
- Acute Disease
- Animals
- Antibodies, Bispecific
(pharmacokinetics, pharmacology, therapeutic use)
- Antineoplastic Agents
(pharmacokinetics, pharmacology, therapeutic use)
- Clinical Trials as Topic
- Drug Interactions
- Humans
- Mice
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
(drug therapy, immunology)
- Remission Induction
- T-Lymphocytes
(immunology)
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