Full Press Release Details
THOUSAND OAKS, Calif. , Dec. 6, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced new data from its hematology pipeline and marketed portfolio to be presented at the 63 rd American Society of Hematology (ASH) Annual Meeting & Exposition in Atlanta, Georgia , and virtually, from Dec. 11-14, 2021 .
"The data being presented at ASH demonstrates Amgen's commitment to reaching more patients with our innovative hematology medicines and improving the patient experience by exploring more convenient administrations for people living with blood cancers," said David M. Reese , M.D., executive vice president of Research and Development at Amgen. "By accelerating the development and delivery of transformative medicines in difficult to treat and vulnerable patient populations, including children and pregnant women, we continue to focus on the relentless pursuit of breakthroughs for blood cancer patients and their families."
Amgen will present data on its bispecific T-cell engager (BiTE ® ) platform, including BLINCYTO ® (blinatumomab), as well as KYPROLIS ® (carfilzomib) and Nplate ® (romiplostim). Updated data from the Phase 3 '215 trial in children with high-risk first relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) showed BLINCYTO improved event-free survival (EFS) and overall survival (OS) versus chemotherapy before allogeneic hematopoietic stem cell transplant (alloHSCT). The first presentation of safety and efficacy data with BLINCYTO administered subcutaneously in adults with relapsed or refractory B-ALL also demonstrated encouraging results.
Additionally, results from the Phase 1b study investigating KYPROLIS in combination with vincristine, dexamethasone, PEG-asparaginase, daunorubicin (VXLD) induction therapy in children with relapsed or refractory ALL showing promising efficacy in highly advanced relapsed/refractory pediatric ALL will be presented in a poster discussion session. Analyses from the Pregnancy Surveillance Program (PSP) evaluating pregnancy and fetal outcomes of women exposed to Nplate highlighting no substantial safety concerns identified for mothers, fetuses and infants due to Nplate use during pregnancy will also be shared as an oral presentation on Monday, Dec. 13, 2021 .
Abstracts are available on the ASH website .
Key Abstracts and Presentation Times:
Disease State Amgen Sponsored Abstracts
BLINCYTO Amgen Sponsored Abstracts
BLINCYTO Investigator Sponsored Studies (ISS)
KYPROLIS Amgen Sponsored Abstracts
KYPROLIS Investigator Sponsored Studies (ISS)
Nplate Clinical Data Abstracts
Nplate Investigator Sponsored Studies (ISS)
About the 20120215 Study Study 20120215 is a Phase 3 open-label, multicenter, randomized, controlled trial evaluating event-free survival (EFS) after treatment with BLINCYTO compared with standard of care consolidation chemotherapy in pediatric patients with high-risk first-relapse B-cell ALL. In September 2019 , the BLINCYTO arm showed superior efficacy on the primary endpoint of EFS, exceeding the prespecified stopping boundary; based on the recommendation from the Independent Data Monitoring Committee (DMC), Amgen terminated enrollment. Key secondary endpoints included overall survival and MRD response, adverse events (AEs), 100-day mortality after alloHSCT, incidence of anti-blinatumomab antibody formation, cumulative incidence of relapse. This is a global study that is being conducted as part of the PIP (Pediatric Investigation Plan) agreed to between Amgen and the EMA and is being conducted in Australia and various countries in the EU and Latin America. Click here to read about the trial on ClinicalTrials.gov .
About BLINCYTO ® (Blinatumomab) BLINCYTO is a BiTE ® (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.
BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration and is approved in the U.S. for the treatment of:
In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of:
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
Contraindications
BLINCYTO ® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Warnings and Precautions
Adverse Reactions
Dosage and Administration Guidelines
Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com .
About BiTE ® Technology BiTE ® (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com .
About KYPROLIS ® (carfilzomib) Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. 1 KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells. 2 In some cells, KYPROLIS can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins. 1,2
Since its first approval in 2012, approximately 200,000 patients worldwide have received KYPROLIS. 3 KYPROLIS is approved in the U.S. for the following:
KYPROLIS is also approved in Algeria , Argentina , Australia , Bahrain , Belarus , Brazil , Canada , Chile , Colombia , Ecuador , Egypt , European Union, Hong Kong , India , Israel , Japan , Jordan , Kazakhstan , Kuwait , Lebanon , Macao , Malaysia , Mexico , Morocco , New Zealand , Oman , Peru , Philippines , Qatar , Russia , Saudi Arabia , Serbia, Singapore , S. Africa, S. Korea, Switzerland , Taiwan , Thailand , Turkey and United Arab Emirates .
U.S. KYPROLIS ® (carfilzomib) Important Safety Information
IMPORTANT SAFETY INFORMATION FOR KYPROLIS
Cardiac Toxicities
Acute Renal Failure
Tumor Lysis Syndrome
Pulmonary Toxicity
Pulmonary Hypertension
Venous Thrombosis
Infusion Reactions
Thrombocytopenia
Hepatic Toxicity and Hepatic Failure
Thrombotic Microangiopathy
Posterior Reversible Encephalopathy Syndrome (PRES)
Progressive Multifocal Leukoencephalopathy (PML)
Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients
Embryo-fetal Toxicity
Adverse Reactions
Please see accompanying full Prescribing Information.
About Multiple Myeloma Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse. 4 It is a rare and life-threatening disease that accounts for approximately one percent of all cancers. 4,5 Worldwide, approximately 176,000 people are diagnosed with multiple myeloma each year, and 117,000 patient deaths are reported on an annual basis. 5
About Nplate ® (romiplostim) Nplate is a thrombopoietin (TPO) receptor agonist that mimics the body's natural TPO and is designed to increase platelet counts in patients with ITP. 6
In the European Union (EU):
Nplate is also approved in 69 countries, including Canada and Australia.
For more information about Nplate, please visit www.Nplate.com .
IMPORTANT SAFETY INFORMATION
Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia
Thrombotic/Thromboembolic Complications
Loss of Response to Nplate ®
Adverse Reactions
Nplate ® administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate ® . In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate ® therapy.
INDICATIONS Nplate ® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate ® is indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Nplate ® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. Nplate ® should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate ® should not be used in an attempt to normalize platelet counts.
Please see full Prescribing Information and Medication Guide.
About Amgen Oncology At Amgen Oncology, our mission to serve patients drives all that we do. That's why we're relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.
For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.
At Amgen, we're advancing oncology at the speed of life™.
About Amgen 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 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.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's .
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CONTACT: Amgen, Thousand Oaks Trish Rowland , 805-447-5631 (media) Megan Fox , 805-447-1423 (media) Arvind Sood , 805-447-1060 (investors)