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THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif. (Nov. 6, 2014) – Amgen (NASDAQ:AMGN) and its subsidiary, Onyx Pharmaceuticals, Inc., today announced that more than 50 abstracts from the Company’s oncology and hematology portfolios have been accepted for presentation at the 56th Annual Meeting and Exposition of the American Society of Hematology (ASH) being held December 6 – 9, 2014 in San Francisco.
Presentations include data from blinatumomab studies in adult acute lymphoblastic leukemia (ALL) and relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
“The presentations at ASH demonstrate our commitment to taking on the toughest challenges in hematology and oncology by developing innovative treatments for patients with difficult-to-treat blood cancers,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “These data demostrate Amgen’s commitment to advancing scientific knowledge to improve patient care.”
A full list of Amgen abstracts is currently available on the ASH at: https://ash.confex.com/ash/2014/webprogram/start.html.
Notable abstracts of interest:
Data on two investigational bispecific T cell engager (BiTE®) antibody constructs, blinatumomab and AMG 330, will be presented at ASH. BiTE® antibody constructs represent an innovative immunotherapy approach that helps the body's immune system target cancer cells.
Key data on blinatumomab include two analyses from Study ’211, a pivotal Phase 2 trial in patients with ALL; results from BLAST, a confirmatory single-arm, Phase 2 study in patients with minimal residual disease positive ALL; and long-term follow-up data from Study ’206, an exploratory Phase 2 study in patients with relapsed/refractory B-precursor ALL.
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.
Blinatumomab is an investigational BiTE® antibody construct 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. Blinatumomab, the first of the investigational BiTE® antibody constructs, has received orphan drug designation from the FDA and European Medicines Agency (EMA), and breakthrough therapy and priority review designation from the FDA for the treatment of ALL. The FDA has accepted for review the Biologics License Application (BLA) for blinatumomab, and a Marketing Authorization Application (MAA) has been submitted to the EMA via the centralized procedure for approval to market blinatumomab for the treatment of adults with Ph- relapsed/refractory B-precursor ALL. Blinatumomab has also received orphan drug designation from the FDA for the treatment chronic lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia and indolent B-cell lymphoma and from the EMA for the treatment of indolent B-cell lymphoma, CLL and mantle cell leukemia (MCL). Blinatumomab is also being investigated for its potential to treat pediatric relapsed/refractory ALL, relapsed/refractory Philadelphia positive (Ph+) B-precursor ALL, minimal residual disease positive (MRD+) B-precursor ALL, relapsed/refractory non-Hodgkin's lymphoma (NHL), including relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
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.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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