Amgen 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). 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)
Filed Under: Drug Discovery
