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THOUSAND OAKS, Calif. (July 16, 2015) -- Amgen (NASDAQ:AMGN) today 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. 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.
“These top-line results are encouraging and support blinatumomab as a potential treatment option for patients with relapsed or refractory Philadelphia chromosome-positive B-cell precursor ALL,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We are hopeful that our comprehensive ALL development program for blinatumomab, the first clinical and regulatory validation of the BiTE® platform, will continue to demonstrate clinical effectiveness for patients with this serious disease.”
Philadelphia chromosome-positive B-cell precursor ALL
Approximately one-fourth of adult ALL expresses the oncogenic protein BCR-ABL that results from the t (9;22) chromosome translocation known as the Philadelphia chromosome.
Trial Design (NCT02000427)
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.
About BLINCYTO® (blinatumomab)
BLINCYTO® (blinatumomab) is the first bispecific CD19-directed CD3 T cell engager (BiTE®) antibody construct product, and the first single-agent immunotherapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL, a rare and rapidly progressing cancer of the blood and bone marrow.1,2 Prior to approval, BLINCYTO was granted breakthrough therapy and priority review designations by the FDA. BLINCYTO has a BOXED WARNING in its product label regarding Cytokine Release Syndrome (CRS) and Neurological Toxicities. (Please see Important Safety Information below).
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 Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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
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 one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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