THOUSAND OAKS - Amgen (NASDAQ: AMGN) today announced new data from its hematology pipeline and marketed portfolio to be presented at the 63rd 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.
Key Abstracts and Presentation Times: Disease State Amgen Sponsored Abstracts
Real World Assessment of Treatment Patterns and Outcomes Among Multiple Myeloma Patients Across Different Risk Stratification Criteria in the United States: A Retrospective Cohort Study
Abstract #1640, Poster Presentation, Saturday, Dec. 11 from 5:30 - 7:30 p.m. ET
Outcomes of Triple-Class (Proteasome Inhibitor, Immunomodulator, CD38
Monoclonal Antibody) Exposed Relapsed or Refractory Multiple Myeloma (RRMM) in United States (US) Real-World Practice
Abstract #3042, Poster Presentation, Sunday, Dec. 12 from 6 - 8 p.m. ET
A Temporal and Multinational Assessment of Acute Myeloid Leukemia (AML)
Cancer Incidence, Survival and Disease Burden
Abstract #4124, Poster Presentation, Monday, Dec. 13 from 6 - 8 p.m. ET
BLINCYTO Amgen Sponsored Abstracts
Superior Overall Survival With Blinatumomab Versus Chemotherapy in Children With High-Risk First Relapse of B-cell Precursor Acute Lymphoblastic Leukemia: A Randomized, Controlled Phase 3 Trial
Abstract #1231, Poster Presentation, Saturday, Dec. 11 from 5:30 - 7:30 p.m. ET
Safety and Efficacy of Subcutaneous (SC) Blinatumomab for the Treatment of Adults with Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
Abstract #2303, Poster Presentation, Sunday, Dec. 12 from 6 - 8 p.m. ET
A Phase 1b Study of Blinatumomab Regimen Including Subcutaneous Administration in Relapsed / Refractory (R/R) Indolent Non-Hodgkin's Lymphoma (NHL)
Abstract #2436, Poster Presentation, Sunday, Dec. 12 from 6 - 8 p.m. ET
Heterogeneity of Minimal/Measurable Residual Disease (MRD) Practices in Adult B-Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) in the United States
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.
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.
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
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 U.S: Nplate is approved for the treatment of thrombocytopenia in adult patients with ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Nplate is approved 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.
Adult ITP
In the placebo-controlled trials of adult ITP patients, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate and 32% of patients receiving placebo. Adverse drug reactions in adults with a 5% higher patient incidence in Nplate versus placebo were Arthralgia (26%, 20%), Dizziness (17%, 0%), Insomnia (16%, 7%), Myalgia (14%, 2%), Pain in Extremity (13%, 5%), Abdominal Pain (11%, 0%), Shoulder Pain (8%, 0%), Dyspepsia (7%, 0%), and Paresthesia (6%, 0%).
The safety profile of Nplate was similar across patients, regardless of ITP duration. The following adverse reactions (at least 5% incidence and at least 5% more frequent with Nplate compared with placebo or standard of care) occurred in Nplate patients with ITP duration up to 12 months: bronchitis, sinusitis, vomiting, arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough, nausea and oropharyngeal pain. The adverse reaction of thrombocytosis occurred with an incidence of 2% in adults with ITP duration up to 12 months.
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.
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:
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Tel: 805-447-5631
AMGEN INC. 
