Amgen at 20th Congress of EHA

Amgen announced that it will present data from multiple Kyprolis® (carfilzomib) for injection, Blincyto® (blinatumomab), oprozomib and Nplate® (romiplostim) studies at the 20th 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 haematologic 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 leukaemia, to make a positive impact for patients who desperately need more options,” said Sean E. Harper, MD, 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 leukaemia (ALL), Waldenström macroglobulinaemia 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 III head-to-head ENDEAVOR trial evaluating Kyprolis and dexamethasone compared to Velcade® (bortezomib) and dexamethasone, as well as results from the Phase I/II CHAMPION-1 study and a secondary analysis from the pivotal Phase III ASPIRE study.

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• Carfilzomib and dexamethasone improves progression-free survival and response rates versus bortezomib and dexamethasone in patients with relapsed multiple myeloma: the Phase III study ENDEAVOR.
• Abstract No. LB2071, Late-breaking Oral Presentation, Session Title: Late-breaking Abstracts 2, Sunday, June 14, Presentation Time: noon – 12:15PM Central European Time (CET), Room A7.
• Effect of carfilzomib, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone in patients with relapsed multiple myeloma by line of therapy: interim results from the Phase III ASPIRE study.
• Abstract No. S427, Oral Presentation, Session Title: Multiple Myeloma – Clinical Studies 2, Saturday, June 13, Presentation Time: 11:45AM – noon CET, Room A2+3.
• Weekly carfilzomib with dexamethasone for patients with relapsed or refractory multiple myeloma: updated results from the Phase I/II study CHAMPION-1 (NCT01677858).
• Abstract No. P269, Poster Presentation, Session Title: Multiple Myeloma – Clinical 1, Friday, June 12, 5:15PM – 6:45PM CET, Poster Area (Hall C).
• Impact of carfilzomib on health-related quality of life: results from a Phase II 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, 4:15PM – 6:15PM 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 II studies.
• Abstract No. S115, Oral Presentation, Session Title: ALL Clinical Trials, Friday, June 12, Presentation Time: 12:30PM – 12:45PM CET, Room C1.
• Retreatment with blinatumomab after CD-19-positive relapse: experience from three trials in patients with relapsed/refractory B-precursor acute lymphoblastic leukaemia.
• 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 leukaemia treated with blinatumomab.
• Abstract No. P161, Poster Presentation, Session Title: Acute Lymphoblastic Leukemia – Clinical 1, Friday, June 12, 5:15PM – 6:45PM CET, Poster Area (Hall C).
• Satellite Symposium: T-cell engagement strategies for ALL: examining the emerging data.
• Thursday, June 11, 1:30PM – 3:30PM 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 haematologic malignancies, including multiple myeloma and Waldenström macroglobulinaemia, 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, 5:15PM – 6:45PM CET, Poster Area (Hall C).
• Updated results from a multicentre, open-label, dose escalation Phase Ib/II study of single-agent oprozomib in patients with haematologic malignancies, including multiple myeloma.
• Abstract No. P646, Poster Presentation, Session Title: Multiple Myeloma – Clinical 3, Saturday, June 13, 5:15PM – 6:45PM CET, Poster Area (Hall C).
• Updated results from a multicentre, open-label, dose escalation Phase 1b/2 study of single-agent oprozomib in patients with haematologic malignancies, including Waldenström macroglobulinaemia.
• 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.