The results of a prespecified interim analysis have shown that the primary endpoint of improved overall survival was met in the phase 3 TOWER study.
The randomized, open-label TOWER study evaluated the efficacy of Blinatumomab ( Blincyto ) versus standard of care ( SOC ) in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia ( ALL ).
The independent data monitoring committee recommended, and Amgen has accepted, that the study end early for efficacy.

The adverse events observed in the TOWER study were consistent with the known safety profile of Blinatumomab.

Secondary endpoints are currently being evaluated.

The TOWER study was a phase 3, randomized, open-label study investigating the efficacy of the BiTE antibody Blinatumomab versus SOC chemotherapy in adult subjects with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.
Patients were randomized in a 2:1 ratio to receive Blinatumomab or treatment with investigator choice of one of four protocol defined SOC chemotherapy regimens.
The primary endpoint was overall survival.

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 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 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 the cancer cell to die ( apoptosis ). ( Xagena )

Source: Amgen, 2016

XagenaMedicine2016