blinatumomab

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Ligands
blinatumomab

GtoPdb Ligand ID: 7384

Synonyms: Blincyto® | bscCD19xCD3 | MEDI-538 | MT-103 | MT103 [2]

blinatumomab is an approved drug (FDA (2014), EMA (2015))

Comment: Blinatumomab is a monoclonal antibody with anti-cancer effects. Its mechanism of action classifies this antibody as a member of the bi-specific T-cell engager (BiTE®) group of engineered antibodies. It was the first biologic of this class to gain clinical approval.
Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record.

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Summary of Clinical Use
In December 2014 the FDA approved blinatumomab for use in the treatment of Philadelphia chromosome-negative (Ph-) precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL. Full approval for use in the European Union (to treat Ph- relapsed/refractory B-precursor ALL) was granted in November 2015, subsequent to orphan drug designation since mid 2014. In July 2017, the FDA expanded approval to include treatment of relapsed/refractory B-cell precursor ALL in adults and children, based on data from the Phase 3 TOWER study that shows that blinatumomab single agent therapy exhibits superior improvement in median overall survival over standard of care chemotherapy. This is the first single-agent immunotherapy approved to treat patients with Ph- relapsed or refractory B-cell precursor ALL. March 2018 saw FDA approval expanded further to include treatment of adult and pediatric patients with B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD), based on the BLAST trial (NCT01207388) [4]. Blinatumomab is undergoing clinical trial for other forms of ALL and lymphoma. A list of current trials can be viewed at ClinicalTrials.gov.

Summary of Clinical Use

In December 2014 the FDA approved blinatumomab for use in the treatment of Philadelphia chromosome-negative (Ph-) precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL. Full approval for use in the European Union (to treat Ph- relapsed/refractory B-precursor ALL) was granted in November 2015, subsequent to orphan drug designation since mid 2014.
In July 2017, the FDA expanded approval to include treatment of relapsed/refractory B-cell precursor ALL in adults and children, based on data from the Phase 3 TOWER study that shows that blinatumomab single agent therapy exhibits superior improvement in median overall survival over standard of care chemotherapy. This is the first single-agent immunotherapy approved to treat patients with Ph- relapsed or refractory B-cell precursor ALL. March 2018 saw FDA approval expanded further to include treatment of adult and pediatric patients with B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD), based on the BLAST trial (NCT01207388) [4].

Blinatumomab is undergoing clinical trial for other forms of ALL and lymphoma. A list of current trials can be viewed at ClinicalTrials.gov.

Mechanism Of Action and Pharmacodynamic Effects
Structurally, blinatumomab carries peptide sequences which interact with CD3e (part of the T cell receptor, TCR, of T cells) and CD19 found on B cells. Functionally, the antibody creates a temporary physical connection between cytotoxic T cells and target cancer cells which activates a cytotoxic signalling pathway to destroy the cancer cells. This activity is particularly effective as it circumvents common tumour cell resistance mechanisms [1,6-7].

Mechanism Of Action and Pharmacodynamic Effects

Structurally, blinatumomab carries peptide sequences which interact with CD3e (part of the T cell receptor, TCR, of T cells) and CD19 found on B cells. Functionally, the antibody creates a temporary physical connection between cytotoxic T cells and target cancer cells which activates a cytotoxic signalling pathway to destroy the cancer cells. This activity is particularly effective as it circumvents common tumour cell resistance mechanisms [1,6-7].

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT01207388	Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)	Phase 2 Interventional	Amgen Research (Munich) GmbH