Date: 2016-02-05
Type of information: Results
phase: 3
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: Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Therapeutic area: Cancer - Oncology
Country: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Republic of Korea, Mexico, Poland, Russian Federation, Spain, Taiwan, Turkey, UK, USA
Trial
details: The TOWER study is a Phase 3, randomized, open-label study investigating the efficacy of the BiTE® antibody Blincyto® 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 Blincyto® or treatment with investigator choice of one of four protocol defined SOC chemotherapy regimens. The primary endpoint was overall survival. (NCT02013167)
Latest
news: * On February 4, 2016, Amgen announced that the results of a prespecified interim analysis showed 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 Blincyto® (blinatumomab) 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 Blincyto® adverse events observed in the TOWER study were consistent with the known safety profile of Blincyto®. Secondary endpoints are currently being evaluated. These interim data will be submitted to a future medical conference and for publication.
