Presentations Including Pivotal Data on Kyprolis® and Blinatumomab, a BiTE® Immunotherapy, Demonstrate Company's Continued Commitment to Developing Treatments for Difficult-to-Treat Blood Cancers
THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Nov. 6, 2014 /PRNewswire/ -- 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 Dec. 6 – 9, 2014, in San Francisco.
Presentations include data from the pivotal trial of Kyprolis® (carfilzomib) for Injection in relapsed multiple myeloma, and blinatumomab studies in adult acute lymphoblastic leukemia (ALL) and relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Additional data will be presented evaluating oprozomib in multiple myeloma and Waldenström macroglobulinemia, AMG 330 in acute myeloid leukemia (AML), and an analysis of Onyx's patient support and services program Onyx Pharmaceuticals 360TM (Onyx 360).
"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 demonstrate Amgen's commitment to advancing scientific knowledge to improve patient care."
A full list of Amgen abstracts is currently available on the ASH website at: https://ash.confex.com/ash/2014/webprogram/start.html.
Notable abstracts of interest:
Kyprolis® (carfilzomib) for Injection
Results will be presented from ASPIRE, a randomized, open-label, multicenter Phase 3 study comparing carfilzomib, lenalidomide, and dexamethasone to lenalidomide, and dexamethasone in patients with relapsed multiple myeloma.
- Carfilzomib, Lenalidomide, and Dexamethasone vs. Lenalidomide and Dexamethasone in Patients with Relapsed Multiple Myeloma: Interim Results from ASPIRE, a Randomized, Open-Label, Multicenter Phase 3 Study
Abstract # 79, Oral Presentation, Sunday, December 7, 12:00 p.m. PT (Session: 12:00-1:30 p.m. PT), West Building, 2001-2003-2014-2016
BiTE® Antibody Constructs (blinatumomab and AMG 330)
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.
- Allogeneic Hematopoietic Stem Cell Transplantation Following anti-CD19 BiTE® Blinatumomab in Adult Patients with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Abstract # 965, Poster Presentation, Saturday, December 6, 5:30-7:30 p.m. PT, North Building, Hall E
- 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
Abstract # 3704, Poster Presentation, Monday, December 8, 6:00-8:00 p.m. PT, North Building, Hall E
- BLAST: A Confirmatory, Single-Arm, Phase 2 Study of Blinatumomab, a Bispecific T-Cell Engager (BiTE®) Antibody Construct, in Patients With Minimal Residual Disease B-Precursor Acute Lymphoblastic Leukemia
Abstract # 379, Oral Presentation, Monday, December 8, 10:30 a.m. PT, (Session: 10:30 a.m.-12:00 p.m. PT), West Building, 3009-3011-3022-3024
- Long-term Survival in Adult Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia who Achieved Minimal Residual Disease Response Following Anti-CD19 BiTE® Blinatumomab
Abstract # 2287, Poster Presentation, Sunday, December 7, 6:00-8:00 p.m. PT, North Building, Hall E
- Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma with the Bispecific T-Cell Engager (BiTE®) Antibody Construct Blinatumomab: Primary Analysis Results From an Open-Label, Phase 2 Study
Abstract # 4460, Poster Presentation, Monday, December 8, 6:00-8:00 p.m. PT, West Building, Level 1
Key data on AMG 330 include three preclinical studies evaluating its potential as a therapeutic agent in AML.
- The Broad Activity of the CD33/CD3 Bispecific BiTE® Antibody AMG 330 in Primary Human AML is Impacted By Disease Stage and Cytogenetic/Molecular Risk
Abstract # 266, Oral Presentation, Monday, December 8, 7:15 a.m. PT (Session: 7:00-8:30 a.m. PT), South Building, Esplanade 301
- Hydroxyurea is Most Suitable for Cytoreduction of AML Prior to CD33/CD3 Bispecific BiTE® Antibody (AMG 330) Therapy: Uncompromised T-Cell Proliferation Ex-Vivo and CD33 Upregulation on AML Cells
Abstract # 986, Poster Presentation, Saturday, December 6, 5:30-7:30 p.m. PT, North Building, Hall E
- PD-1/PD-L1 Blocking Enhances CD33/CD3-Bispecific BiTE® Antibody (AMG 330) Mediated Lysis of Primary AML Cells
Abstract # 3738, Poster Presentation, Monday, December 8, 6:00-8:00 p.m. PT, North Building, Hall E
Results will be presented from two Phase 1b/2 studies, including one trial evaluating oprozomib in adult patients with hematologic malignancies who have relapsed after receiving ≥1 line of therapy and another trial in patients with a form of non-Hodgkin's lymphoma. Oprozomib was recently granted orphan drug designation for the treatment of Waldenström macroglobulinemia and multiple myeloma.
- Clinical Profile of Single-Agent Oprozomib in Patients With Multiple Myeloma: Updated Results From a Multicenter, Open-Label, Dose Escalation Phase 1b/2 Study
Abstract # 34, Oral Presentation, Saturday, December 6, 12:45 p.m. PT (Session: 12:00-1:30 p.m. PT), West Building, 2001-2003-2014-2016
- Updated Results From a Multicenter, Open-Label, Dose-Escalation Phase 1b/2 Study of Single-Agent Oprozomib in Patients With Waldenström Macroglobulinemia
Abstract # 1715, Poster Presentation, Saturday, December 6, 5:30-7:30 p.m. PT, West Building, Level 1
Onyx Pharmaceuticals 360™ (Onyx 360)
Onyx Pharmaceuticals and Cancer Support Community established an integrated patient assistance program, Onyx 360, to screen and refer patients/caregivers facing advanced multiple myeloma for psychosocial services. Results will be reported evaluating the impact of distress screening on the utilization of resources offered by Onyx 360 and the effect of these resources on patient distress levels over time.
- Impact of a Patient-Access Program with Integrated Distress Screening on Resource Utilization and Psychosocial Distress Levels in Patients with Multiple Myeloma
Abstract # 1319, Poster Presentation, Saturday, December 6, 5:30-7:30 p.m. PT, North Building, Hall E
About Kyprolis® (carfilzomib) for Injection
On July 20, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Kyprolis® (carfilzomib) for Injection for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Kyprolis is marketed in the U.S. by Onyx Pharmaceuticals, Inc., an Amgen subsidiary.
Important Safety Information Regarding Kyprolis® (carfilzomib) for Injection
Safety data have been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent Kyprolis. There were 37 deaths in the Phase 2 studies, or 7% of patients. The most common causes of death, other than disease progression, were cardiac (5 patients), end-organ failure (4 patients), and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia; pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of Kyprolis administration. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months, and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2% of patients treated with Kyprolis and was Grade 3 or greater in less than 1% of patients. Dyspnea was reported in 35% of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events, and 1 death (Grade 5) was reported.
Infusion reactions, characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina can occur immediately following or up to 24 hours after administration of Kyprolis. Administration of dexamethasone prior to Kyprolis reduces the incidence and severity of reactions. Tumor lysis syndrome (TLS) occurred following Kyprolis administration in < 1% of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a dose reduction in 1% of patients and discontinuation of treatment with Kyprolis in < 1% of patients.
Cases of hepatic failure, including fatal cases, have been reported (< 1%). Kyprolis can cause elevations of serum transaminases and bilirubin.
There are no adequate and well-controlled studies in pregnant women using Kyprolis. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis.
The most common serious adverse reactions were pneumonia, acute renal failure, pyrexia, and congestive heart failure. The most common adverse reactions (incidence of 30% or greater) observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. Serious adverse reactions were reported in 45% of patients.
Full prescribing information is available at http://www.kyprolis.com.
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.
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.
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc., an Amgen subsidiary, is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Onyx Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.
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