OREANDA-NEWS. May 28, 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 20thCongress 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), Waldenstr?m 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 Waldenstr?m 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 Waldenstr?m 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

About Kyprolis® (carfilzomib) for Injection
On July 20, 2012, the U.S. FDA granted accelerated approval of Kyprolis for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD) and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. Kyprolis is under regulatory review by the European Medicines Agency (EMA).

Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals is a subsidiary of Amgen and holds development and commercialization rights to Kyprolis globally, excluding Japan. Kyprolis is also approved for use in Argentina, Israel and Mexico. For more information about Kyprolis, visit www.kyprolis.com.

Important Safety Information Regarding Kyprolis® (carfilzomib) for Injection
This safety information is specific to the current U.S. approved indication, which is based on Phase 2 studies.

Safety data have been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent Kyprolis. There were 37 deaths in the Phase 2 studies, or 7 percent of patients. The most common causes of death, other than disease progression, were cardiac events (5 patients), end-organ failure (4 patients) and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia, pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity, thrombotic thrombocytopenic purpura / hemolytic uremic syndrome (TTP/HUS), posterior reversible encephalopathy syndrome (PRES), and embryo-fetal toxicity.

Death due to cardiac arrest has occurred within a day of Kyprolis administration. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications.

Pulmonary arterial hypertension (PAH) was reported in 2 percent of patients treated with Kyprolis and was Grade 3 or greater in less than 1 percent of patients. Dyspnea was reported in 35 percent of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5 percent; no Grade 4 events and 1 death (Grade 5) was reported.

Infusion reactions, characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina can occur immediately following or up to 24 hours after administration of Kyprolis. Administration of dexamethasone prior to Kyprolis reduces the incidence and severity of reactions. Tumor lysis syndrome (TLS) occurred following Kyprolis administration in <1 percent of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.

Thrombocytopenia following Kyprolis administration resulted in a dose reduction in 1 percent of patients and discontinuation of treatment with Kyprolis in <1 percent of patients.

Cases of hepatic failure, including fatal cases, have been reported (<1 percent). Kyprolis can cause elevations of serum transaminases and bilirubin.

Cases of thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) including fatal outcome have been reported in patients who received KYPROLIS.

PRES, formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS), is a neurological disorder, which can present with seizure, headache, lethargy, confusion, blindness, altered consciousness, and other visual and neurological disturbances, along with hypertension, and the diagnosis is confirmed by neuro-radiological imaging (MRI). Cases of PRES have been reported in patients receiving KYPROLIS.

There are no adequate and well-controlled studies in pregnant women using Kyprolis. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis.

The most common serious adverse reactions were pneumonia, acute renal failure, pyrexia and congestive heart failure. The most common adverse reactions (incidence of 30 percent or greater) observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea and pyrexia. Serious adverse reactions were reported in 45 percent of patients.

Full prescribing information is available at www.kyprolis.com.