Amgen (AMGN) To Present New Data

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Amgen To Present New Data At 22nd Congress of the European Hematology Association

Oral Presentation of Phase 3 Data Shows KYPROLIS® (Carfilzomib) and Dexamethasone Improved Median Overall Survival by 7.6 Months Compared to Velcade® (Bortezomib) and Dexamethasone in Relapsed Multiple Myeloma

New Subset Analysis Demonstrates BLINCYTO® (Blinatumomab) More Than Doubled Median Overall Survival Versus Standard of Care Chemotherapy in Adult Patients With Relapsed/Refractory Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in First Salvage

Oral Presentation of New Data From Head-to-Head Phase 3 Study of XGEVA® (Denosumab) Versus Zoledronic Acid in Time to First On-Study Skeletal-Related Event in Multiple Myeloma Patients

 Amgen (AMGN) today announced that new clinical data and analyses from its hematology portfolio will be presented at the 22nd Congress of the European Hematology Association (EHA) in Madrid, June 22-25, 2017. Key data will be presented from studies evaluating KYPROLIS® (carfilzomib), BLINCYTO® (blinatumomab), XGEVA® (denosumab) and Nplate® (romiplostim).

“Helping patients live longer is the ultimate goal of all of our oncology therapeutic research and development,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The KYPROLIS and BLINCYTO overall survival data at EHA are impressive and give us confidence that we are making significant progress finding effective new therapies for these difficult-to-treat cancers.”

KYPROLIS® is the first-and-only multiple myeloma therapy to demonstrate superior overall survival in a head-to-head comparison with a current standard of care, extending survival by 7.6 months over Velcade® (bortezomib).1 These results from the ENDEAVOR trial will be featured in an oral presentation at EHA.

  • Overall Survival of Patients With Relapsed or Refractory Multiple Myeloma Treated With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone in the Randomized Phase 3 ENDEAVOR Trial
    Abstract #S458, Oral Presentation, Saturday, June 24 at 4:30 p.m. CET in Feria de Madrid, Hall A
  • Updated Results From ASPIRE and ENDEAVOR, Randomised, Open-Label, Multicentre Phase 3 Studies Of Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
    Abstract #P333, Poster Presentation, Friday, June 23 at 5:15 p.m. CET in Feria de Madrid, Poster Area (Hall 7)

A new analysis will be presented from the Phase 3 TOWER study, which demonstrated that in adult patients treated with no prior salvage therapy, BLINCYTO more than doubled median overall survival compared to standard of care chemotherapy in Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). These data come from a subgroup analysis, and TOWER was not powered to assess overall survival efficacy in this subgroup.

  • Blinatumomab Versus SOC Chemotherapy in First Salvage Compared With Second or Greater Salvage in a Phase 3 Study
    Abstract #S478, Oral Presentation, Saturday, June 24 at 4:30 p.m. CET in Feria de Madrid, Hall E
  • Exposure-Adjusted Adverse Events Comparing Blinatumomab With Standard of Care Chemotherapy in Adults With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia From a Randomized Phase 3 Study
    Abstract #P524, Poster Presentation, Saturday, June 24 at 5:30 p.m. CET in Feria de Madrid, Poster Area (Hall 7)
  • Blinatumomab Use in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia From an Open-Label, Multicenter, Expanded Access Study
    Abstract #P521, Poster Presentation, Saturday, June 24 at 5:30 p.m. CET in Feria de Madrid, Poster Area (Hall 7)

New XGEVA data will be presented during an oral session, highlighting results from a post-hoc, 15-month landmark analysis of the Phase 3 ‘482 study, the largest international multiple myeloma trial ever conducted. This analysis demonstrated an improved delay in time to first skeletal-related event for the XGEVA treated patients. The study endpoint and the analysis were not powered to determine efficacy.

  • Comparison of Denosumab (DMB) With Zoledronic Acid (ZA) for the Treatment of Bone Disease in Patients (Pts) With Newly Diagnosed Multiple Myeloma; an International, Randomized, Double Blind Trial
    Abstract #S782, Oral Presentation, Sunday, June 25 at 8:45 a.m. CET in Feria de Madrid, Hall D

On June 16, the U.S. Food and Drug Administration (FDA) accepted for review the XGEVA supplemental Biologics License Application that seeks to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The Prescription Drug User Fee Act (PDUFA) target action date is Feb. 3, 2018. Data from the ‘482 study are also the basis of an application for a variation to the marketing authorization submitted to the European Medicines Agency. Currently, XGEVA is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

The Nplate abstracts to be presented at EHA‎ include data from an ongoing, open-label extension study evaluating the safety and efficacy of Nplate in children with immune thrombocytopenia (ITP):

  • Safety and Efficacy of Long-Term Open-Label Dosing of Subcutaneous (Sc) Romiplostim in Children With Immune Thrombocytopenia (ITP)
    Abstract #P727, Poster Presentation, Saturday, June 24 at 5:30 p.m. CET in Feria de Madrid, Poster Area (Hall 7)
  • A Single-Arm, Open-Label, Long-Term Efficacy and Safety Study of Subcutaneous (Sc) Romiplostim in Children With Immune Thrombocytopenia (ITP)
    Abstract #P367, Poster Presentation, Friday, June 23 at 5:15 p.m. CET in Feria de Madrid, Poster Area (Hall 7)

Abstracts are currently available on the EHA website.

About KYPROLIS® (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.2 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.2,3

KYPROLIS is approved in the U.S. for the following:

  • In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
  • As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

KYPROLIS is also approved in Argentina, Australia, Bahrain, Canada, Hong Kong, Israel, Japan, Kuwait, Lebanon, Macao, Mexico, Thailand, Colombia, S. Korea, Canada, Qatar, Switzerland, United Arab Emirates, Turkey, Russia, Brazil, India and the European Union. Additional regulatory applications for KYPROLIS are underway and have been submitted to health authorities worldwide.

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