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Positive Preliminary Results Reported for Leukemia Drug Blinatumomab (Blincyto)
Positive results have been reported from a phase II, open-label, single-arm, multicenter trial designed to evaluate the efficacy and safety of blinatumomab (Blincyto, Amgen) in adults with relapsed or refractory Philadelphia chromosome-positive (Ph+) B-cell precursor acute lymphoblastic leukemia (ALL).
The investigational study consisted of a screening period, an induction treatment period (two cycles of blinatumomab), a consolidation treatment period (up to three additional cycles of blinatumomab for appropriate subjects), and a safety follow-up visit 30 days after treatment. After the safety follow-up visit, the subjects were followed for response duration and survival every 3 months for 18 months or death, whichever occurred first.
In the study, blinatumomab monotherapy induced complete remission or complete remission with partial hematologic recovery within two cycles of treatment in a “clinically meaningful” number of patients. Amgen provided no further efficacy details. Overall safety results from this study were consistent with the known blinatumomab safety profile.
Blinatumomab is the first bispecific CD19-directed CD3 T-cell engager (BiTE) antibody construct product, and is the first single-agent immunotherapy to be approved by the FDA for the treatment of patients with Philadelphia chromosome-negative (Ph–) relapsed or refractory B-cell precursor ALL. Before approval, blinatumomab was granted “breakthrough therapy” and “priority review” designations by the FDA.
BiTE antibody constructs are a type of immunotherapy being investigated for treating 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 cancer cells, with the intent of allowing the T cells to inject toxins and to trigger apoptosis. BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.
At approximately $178,000 for two courses of treatment, blinatumomab is one of the world’s most expensive cancer treatments.
The drug’s labeling includes a boxed warning regarding the potential for cytokine release syndrome and neurologic toxicities.
Sources: Amgen; July 16, 2015; and Reuters; July 16, 2015.