The primary endpoint of improved overall survival has been met in a phase 3, randomized, open-label study comparing blinatumomab (Blincyto, Amgen) with standard of care in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). An independent data-monitoring committee recommended that the study end early for efficacy.
Blinatumomab is a bispecific CD19-directed CD3 T-cell engager (BiTE) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and to CD3 expressed on the surface of T cells.
BiTE antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger apoptosis. BiTE antibody constructs are currently being investigated for their potential to treat a variety of cancers.
Blinatumomab was granted breakthrough therapy and priority review designations by the FDA, and is now approved for the treatment of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.
Source: Amgen; February 22, 2016.