Date: 2014-12-06
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6-9 in San Francisco, CA
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: minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukemia (ALL)
Therapeutic area: Cancer - Oncology - Rare diseases
Country:
Trial
details: The BLAST study is the largest prospective trial in patients with MRD-positive ALL. It is an open-label, multicenter, confirmatory single-arm, Phase 2 study evaluating the efficacy, safety and tolerability of Blincyto™ in adult patients (=18 years) with MRD positive B-cell precursor ALL in hematologic complete remission (
Latest
news: * On December 6, 2014, Amgen announced new data from the Phase 2 BLAST study which evaluated the bispecific T cell engager (BiTE®) immunotherapy Blincyto™ (blinatumomab) in patients with minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukemia (ALL). In the study, 78 percent of patients who received Blincyto™ experienced a complete MRD response (95 percent CI: 69-85 percent), a measure of eradication of residual disease at the molecular level, after one treatment cycle. Nearly all complete responses (98 percent) occurred within the first treatment cycle. The results from the BLAST study (Study \'203; abstract # 379) will be featured during the 56th American Society of Hematology (ASH) Annual Meeting and Exposition press briefing on Saturday, December 6 , at 10 a.m. PT and will be presented in an oral session at ASH on Monday, December 8 , at 10:30 a.m. PT. MRD is a state of disease in which the microscopic analysis does not show malignant cells, but more sensitive techniques still detect disease at the molecular level. Patients who have persistent or recurrent MRD after their first therapy have a higher risk of relapse than those with no detectable MRD. In addition to the majority (78 percent) of patients achieving a compete MRD response within one cycle of treatment, 80 percent achieved a complete MRD response across all cycles. Responses occurred in all subgroups including older patients and patients with high MRD level; no predictive factor for MRD response was identified. In the study, adverse events (AEs) of all grades occurring in 20 percent or more patients included pyrexia (90 percent), tremor (29 percent), chills (26 percent), fatigue (24 percent), nausea (22 percent), vomiting (22 percent) and diarrhea (20 percent). Grade =3 AEs occurring in five percent or more patients included neutropenia (16 percent), pyrexia (7 percent) and tremor (5 percent). Two fatal AEs occurred on treatment: subdural hemorrhage and pneumonitis in conjunction with influenza (the latter was deemed treatment-related). Treatment interruptions due to AEs occurred in 31 percent of patients.
