The results from the BLAST study (Study '203; abstract # 379) will be featured during the 56th
"BLINCYTO is the most advanced of
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.1 Patients who have persistent or recurrent MRD after their first therapy have a higher risk of relapse than those with no detectable MRD.1
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.
BLAST Phase 2 Trial Design
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 (<5 percent blasts in bone marrow) after three or more intensive chemotherapy treatments. Patients received continuous IV infusion of 15 μg/m2/d for four weeks, followed by two weeks off. Patients received up to four cycles of treatment, or could undergo a hematopoietic stem cell transplantation (HSCT) at any time after the first cycle, if eligible. The primary endpoint is rate of complete MRD response. Secondary endpoints include incidence and severity of AE, hematological relapse-free survival rate, overall survival, time to hematologic relapse, and duration of complete MRD response.
About BLINCYTO™ (blinatumomab)
BLINCYTO is the first BiTE® antibody construct and the first single-agent immunotherapy to be approved by the
About BiTE® Technology
Bispecific T cell engager (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 (a type of white blood cell capable of killing other cells perceived as threats) 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). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com.
Important U.S. Product Information
BLINCYTO is indicated for the treatment of
This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
BLINCYTO™ is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Warnings and Precautions
Dosage and Administration Guidelines
Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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1 National Comprehensive Cancer Network. "Acute Lymphoblastic Leukemia." Available at: http://www.alabmed.com/uploadfile/2014/0214/20140214092732754.pdf. Accessed on
2 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Acute Lymphoblastic Leukemia. Version 1.2014. Available at: https://www.nccn.org/store/login/login.aspx?ReturnURL=http://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Accessed on
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