Date: 2015-07-16
Type of information: Results
phase: 2
Announcement: results
Company: Amgen (USA - CA)
Product: Blincyto® (blinatumomab)
Action
mechanism: bispecific antibody. Blinatumomab is an investigational BiTE® antibody designed to direct the body\'s cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. Bispecific T cell engager (BiTE®) antibodies are a type of immunotherapy being investigated for use in fighting cancer by helping to engage 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 antibodies help place the T cells within reach of the targeted cell, with the intent of allowing it to inject toxins and trigger the cell to die (apoptosis). Blincyto™ is the first BiTE® antibody construct and the first single-agent immunotherapy to be approved by the FDA. The drug was granted breakthrough therapy and priority review designations by the FDA , and is now approved in the U.S. for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Disease: relapsed or refractory Philadelphia chromosome-positive (Ph+) B-cell precursor acute lymphoblastic leukemia (ALL)
Therapeutic area: Cancer - Oncology - Rare diseases
Country: France, Germany, Italy, UK, USA
Trial
details: This study enrolled adult subjects with relapsed or refractory Ph+ B-cell precursor ALL. This was an open-label, single-arm, multicenter study consisting of a screening period, an induction treatment period (two cycles of blinatumomab), a consolidation treatment period (up to three additional cycles of blinatumomab for applicable subjects), and a safety follow-up visit 30 days after treatment. Following the safety follow-up visit, subjects were followed for response duration and survival every 3 months for 18 months or death, whichever occurred first. (NCT02000427)
Latest
news: * On July 16, 2015, Amgen announced the top-line results of a Phase 2 open-label, single-arm, multicenter trial to evaluate the efficacy and safety of Blincyto® (blinatumomab) in adults with relapsed or refractory Philadelphia chromosome-positive (Ph+) B-cell precursor acute lymphoblastic leukemia (ALL). The investigational study showed blinatumomab monotherapy induced a complete remission or complete remission with partial hematological recovery within two cycles of treatment in a clinically meaningful number of patients. Overall safety results from this study were consistent with the known blinatumomab safety profile. The data will be submitted to a future medical conference and for publication.
