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Press Release

Long-Term Analysis Of Phase 3 Head-To-Head Study Confirms KYPROLIS® (Carfilzomib) Regimen Extends Overall Survival In Patients With Relapsed Multiple Myeloma

Amgen
Posted on: 02 Sep 17

ENDEAVOR Study Long-Term Data Shows KYPROLIS and Dexamethasone Reduced the Risk of Death by 24 Percent Versus Velcade® (Bortezomib) and Dexamethasone

Patients Treated With the KYPROLIS-Based Regimen Survived 9.0 Months Longer Than Patients Receiving Velcade and Dexamethasone

Long-Term Follow-Up Demonstrated Consistent Safety Profile

THOUSAND OAKS, Calif., Aug. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive results from a post-hoc analysis requested by the U.S. Food and Drug Administration (FDA) of the Phase 3 head-to-head ENDEAVOR trial, which followed patients for at least three years after enrollment. The analysis evaluated overall survival (OS) and long-term safety of KYPROLIS® (carfilzomib) administered at 56 mg/m2 twice weekly and dexamethasone (Kd) versus Velcade® (bortezomib) and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma. Kd reduced the risk of death by 24 percent over Vd (median OS 47.8 months for Kd versus 38.8 months for Vd, HR=0.76, 95 percent CI, 0.63-0.92; p=0.0017). This Kd regimen is currently approved in the U.S., European Union and other countries based on the primary analysis of progression-free survival in the ENDEAVOR study.

"For physicians making prescribing decisions, long-term follow-up helps to further support the safety and efficacy of a therapy and instills confidence in the treatment," said Robert Orlowski, M.D., Ph.D., Florence Maude Thomas Cancer Research professor and chair, ad interim, Department of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center. "The current three-year follow-up analysis demonstrates that this proteasome inhibitor continues to demonstrate a prolonged overall survival benefit and consistent safety profile when combined with dexamethasone for relapsed multiple myeloma patients."

"We are excited about the three-year follow-up of the ENDEAVOR study as the overall survival benefit reflects both the efficacy and the long-term safety of this KYPROLIS regimen in patients with relapsed multiple myeloma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "These results confirm that when a patient relapses, KYPROLIS should replace Velcade as a standard-of-care."

Adverse events observed in this updated analysis were consistent with those previously reported for ENDEAVOR. The most common adverse events (greater than or equal to 20 percent) in the KYPROLIS arm were anemia, diarrhea, pyrexia, hypertension, dyspnea, fatigue, cough, insomnia, upper respiratory tract infection, nausea, bronchitis, asthenia, back pain, thrombocytopenia, edema peripheral, headache and muscle spasms.

Results from the primary ENDEAVOR OS analysis were recently published online in The Lancet Oncology. Data showed Kd reduced the risk of death by 21 percent over Vd. Patients treated with KYPROLIS lived 7.6 months longer than those treated with Velcade (median OS 47.6 months for Kd versus 40.0 months for Vd, HR=0.79, 95 percent CI, 0.65-0.96). On Aug. 30, 2017, Amgen announced the FDA accepted for review the supplemental New Drug Application (sNDA) for KYPROLIS to include OS data from the Phase 3 head-to-head ENDEAVOR trial in the product information. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 30, 2018. 

Since its approval in 2012, more than 50,000 patients worldwide have received KYPROLIS. The KYPROLIS clinical program continues to focus on providing solutions for physicians and patients in treating this frequently relapsing and difficult-to-treat cancer. KYPROLIS is available for patients whose myeloma has relapsed or become resistant to another treatment and continues to be studied in a range of combinations and patient populations.

About ENDEAVOR

The randomized ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial of 929 patients evaluated Kd versus Vd in patients whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens. The primary endpoint of the trial was PFS, defined as the time from treatment initiation to disease progression or death. The primary analysis was published in The Lancet Oncology and is described in the Prescribing Information.

Patients received treatment until progression with KYPROLIS as a 30-minute infusion on days 1, 2, 8, 9, 15 and 16 of 28 day treatment cycles, along with low-dose dexamethasone (20 mg). For cycle one only, KYPROLIS was administered at 20 mg/m2 on days 1 and 2, and if tolerated was escalated to 56 mg/m2 from day 8 cycle one onwards. Patients who received bortezomib (1.3 mg/m2) with low-dose dexamethasone (20 mg) were treated with bortezomib administered subcutaneously or intravenously at the discretion of the investigator and in accordance with regional regulatory approval of bortezomib. More than 75 percent of the patients in the control arm received bortezomib subcutaneously. This study was conducted at 235 sites worldwide.

For information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT01568866.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.1 It is a rare and very aggressive disease that accounts for approximately one percent of all cancers.2,3 In the U.S., there are nearly 95,000 people living with, or in remission from, multiple myeloma.4 Approximately 30,330 Americans are diagnosed with multiple myeloma each year and 12,650 patient deaths are reported on an annual basis.4

About KYPROLIS® (carfilzomib) 

Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.5 KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.5 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.5,6

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, Oman and the European Union. Additional regulatory applications for KYPROLIS are underway and have been submitted to health authorities worldwide.

For more information:
investors.amgen.com/phoenix.zhtml?c=61656&p=RssLanding&cat=news&id=2297510

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 02/09/2017

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