Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Amgen (NASDAQ: AMGN) today announced that it will present data from multiple Kyprolis^® (carfilzomib) for Injection, BLINCYTO^® (blinatumomab), oprozomib and Nplate^® (romiplostim)‎ studies at the 20^th Congress of the European Hematology Association (EHA) taking place in Vienna, June 11 - 14, 2015. The data reinforce Amgen's commitment to advancing the care of patients with hematologic malignancies through the development of novel treatment approaches and continued evaluation of marketed products.

"We focus on blood cancers that have high unmet medical need, such as multiple myeloma and acute lymphoblastic leukemia, to make a positive impact for patients who desperately need more options," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The data being presented at EHA show advancements in understanding how novel treatment approaches, such as Kyprolis, BLINCYTO and oprozomib, can work across various patient populations and stages of the treatment continuum."

Key data include findings from clinical trials in multiple myeloma, acute lymphoblastic leukemia (ALL), Waldenström macroglobulinemia and immune thrombocytopenia (ITP). Notable abstracts and satellite symposia of interest include:

Kyprolis
In multiple myeloma, full results will be presented as a late-breaking oral presentation from the Phase 3 head-to-head ENDEAVOR trial evaluating Kyprolis and dexamethasone compared to Velcade^® (bortezomib) and dexamethasone, as well as results from the Phase 1/2 CHAMPION-1 study and a secondary analysis from the pivotal Phase 3 ASPIRE study.

• Carfilzomib and dexamethasone improves progression-free survival and response rates vs. bortezomib and dexamethasone in patients with relapsed multiple myeloma: the Phase 3 study ENDEAVOR
  Abstract No. LB2071, Late-breaking Oral Presentation, Session Title: Late-breaking Abstracts 2, Sunday, June 14, Presentation Time: noon - 12:15 p.m. Central European Time (CET), Room A7
• Effect of carfilzomib, lenalidomide, and dexamethasone vs. lenalidomide and dexamethasone in patients with relapsed multiple myeloma by line of therapy: interim results from the Phase 3 ASPIRE study
  Abstract No. S427, Oral Presentation, Session Title: Multiple Myeloma - Clinical Studies 2, Saturday, June 13, Presentation Time: 11:45 a.m. - noon CET, Room A2+3
• Weekly carfilzomib with dexamethasone for patients with relapsed or refractory multiple myeloma: updated results from the Phase 1/2 study CHAMPION-1 (NCT01677858)
  Abstract No. P269, Poster Presentation, Session Title: Multiple Myeloma - Clinical 1, Friday, June 12, 5:15 p.m. - 6:45 p.m. CET, Poster Area (Hall C)
• Impact of carfilzomib on health-related quality of life: results from a Phase 2 post-hoc analysis of single-agent carfilzomib in patients with relapsed and refractory multiple myeloma
  Abstract No. E1433, e-Poster Presentation
• Satellite Symposium: Charting new depths in the treatment of multiple myeloma
  Thursday, June 11, 4:15 p.m. - 6:15 p.m. CET, Room C2, Messe Wien Vienna

BLINCYTO^® (blinatumomab)
Blinatumomab data at EHA will focus on targeted patient populations within relapsed/refractory ALL to better understand response to treatment.

• Blinatumomab safety and activity in older patients with relapsed/refractory B-precursor acute lymphoblastic leukemia in two Phase 2 studies
  Abstract No. S115, Oral Presentation, Session Title: ALL Clinical Trials, Friday, June 12, Presentation Time: 12:30 p.m. - 12:45 p.m. CET, Room C1
• Retreatment with blinatumomab after CD-19-positive relapse: experience from three trials in patients with relapsed/refractory B-precursor acute lymphoblastic leukemia
  Abstract No. P165, Poster Presentation, Session Title: Acute Lymphoblastic Leukemia - Clinical 1, Friday, June 12, 5:15 p.m. - 6:45 p.m. CET, Poster Area (Hall C)
• Influence of baseline factors on outcomes in patients with relapsed/refractory B-precursor acute lymphoblastic leukemia treated with blinatumomab
  Abstract No. P161, Poster Presentation, Session Title: Acute Lymphoblastic Leukemia - Clinical 1, Friday, June 12, 5:15 p.m. - 6:45 p.m. CET, Poster Area (Hall C)
• Satellite Symposium: T-cell engagement strategies for ALL: examining the emerging data
  Thursday, June 11, 1:30 p.m. - 3:30 p.m. CET, Room Lehar 1 & 2, Reed Messe Vienna

Oprozomib
Updated results will be featured from three dose escalation studies of oprozomib, a novel oral proteasome inhibitor; one in combination with dexamethasone in patients with relapsed and/or refractory multiple myeloma, and two as a single agent in patients with hematologic malignancies, including multiple myeloma and Waldenström macroglobulinemia, respectively.

• Oprozomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma: updated results from dose escalation in a Phase 1b/2, multicenter, open-label study
  Abstract No. P653, Poster Presentation, Session Title: Multiple Myeloma - Clinical 3, Saturday, June 13, 5:15 p.m. - 6:45 p.m. CET, Poster Area (Hall C)
• Updated results from a multicenter, open-label, dose escalation Phase 1b/2 study of single-agent oprozomib in patients with hematologic malignancies, including multiple myeloma
  Abstract No. P646, Poster Presentation, Session Title: Multiple Myeloma - Clinical 3, Saturday, June 13, 5:15 p.m. - 6:45 p.m. CET, Poster Area (Hall C)
• Updated results from a multicenter, open-label, dose escalation Phase 1b/2 study of single-agent oprozomib in patients with hematologic malignancies, including Waldenström macroglobulinemia
  Abstract No. E1154, e-Poster Presentation

Nplate
Interim results from the PLATON trial, an observational clinical practice study of Nplate in patients with ITP, will be presented, focusing on the effect of Nplate on platelet counts in ITP patients in clinical practice, as well as the tolerability of Nplate.

• An observational clinical practice study of romiplostim in patients with chronic immune thrombocytopenic purpura – PLATON interim results
  Abstract No. E1415, e-Poster Presentation

Disease State Research
Amgen will also present a study at EHA that focuses on trends in splenectomy in adult patients with chronic ITP.

• Recent time trends in the uptake of splenectomy in adults diagnosed with chronic immune thrombocytopenia: A nationwide historical cohort study in Denmark, 1996 - 2012
  Abstract No. E1411, e-Poster Presentation