In one analysis from the '211 study, 40 percent of patients treated with BLINCYTO who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) were enabled to proceed to allogeneic hematopoietic stem cell transplant (HSCT). Additionally, a secondary analysis from the study found that 82 percent of patients who had a CR or CRh also had a minimal residual disease (MRD) response, a measure used to predict disease recurrence in patients with ALL.
"The data from the '211 study expand the evidence of
In the study, the most frequent grade >3 adverse events (AEs) occurring in >5 percent of patients were febrile neutropenia (25 percent), neutropenia (16 percent), anemia (14 percent), pneumonia (9 percent), thrombocytopenia (8 percent), hyperglycemia (8 percent), leukopenia (8 percent), alanine aminotransferase increased (7 percent), hypokalemia (7 percent), pyrexia (7 percent), sepsis (6 percent), hypophosphatemia (5 percent). Grade > 3 neurologic events occurred in 13 percent of patients, and grade > 3 cytokine release syndrome occurred in 2 percent of patients.
ASH Abstract 965: Allogeneic Hematopoietic Stem Cell Transplantation Following anti-CD19 BiTE® Blinatumomab in Adult Patients with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
In one analysis of the '211 study, 40 percent of patients treated with BLINCYTO who achieved a CR or CRh were enabled to proceed to HSCT, including both patients who had received prior HSCT and patients who had not received prior HSCT. Additionally, the analysis found that responses to BLINCYTO were similar between patients who had received prior HSCT and patients who had not received HSCT (45 percent versus 42 percent, respectively).
ASH Abstract 3704: An Evaluation of Molecular Response in a Phase 2 Open-Label, Multicenter Confirmatory Study in Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Receiving Treatment with the BiTE® antibody construct Blinatumomab
A secondary analysis of the study demonstrated that, among patients receiving BLINCYTO who had a CR or CRh and had evaluable MRD data (n=73), 82 percent had an MRD response, with 70 percent of those patients achieving a complete MRD response. Median overall survival was longer among patients who had a CR or CRh and an MRD response compared to patients who didn't have an MRD response (11.5 months [95 percent CI, 8.5 – not estimable] versus 6.7 months [95 percent CI, 2.0 – not estimable], respectively).
In the U.S., more than 6,000 cases of ALL will be diagnosed in 2014, and in the
'211 Phase 2 Trial Design
The single arm, open-label, multicenter Phase 2 trial evaluated the safety and efficacy of BLINCYTO in adult patients with
About BLINCYTO™ (blinatumomab)
BLINCYTO is the first BiTE® antibody construct and the first single-agent immunotherapy to be approved by the U.S.
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
The most commonly reported adverse reactions (> 20%) in clinical trials were pyrexia (62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%), hypokalemia (23%), rash (21%), tremor (20%) and constipation (20%).
Dosage and Administration Guidelines
Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com.
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2 Gatta G, Maarten van der Zwan J, Casali P, et. al. Rare cancers are not so rare: The rare cancer burden in
4 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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