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Press Release

Overall Survival Analysis From KYPROLIS® (carfilzomib) Phase 3 Endeavor Trial Published In The Lancet Oncology

BioMarin Pharmaceutical
Posted on: 25 Aug 17

KYPROLIS and Dexamethasone Reduced the Risk of Death by 21 Percent Compared to Velcade® (bortezomib) and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients

KYPROLIS is the First and Only Multiple Myeloma Therapy Proven to Extend Overall Survival in a Head-to-Head Comparison With a Current Standard of Care in the Relapsed Setting

THOUSAND OAKS, Calif., Aug. 23, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that results from an overall survival (OS) analysis of the Phase 3 head-to-head ENDEAVOR trial were published online first in The Lancet Oncology. Data showed that KYPROLIS® (carfilzomib) administered at 56 mg/m2 twice weekly and dexamethasone (Kd56) reduced the risk of death by 21 percent over Velcade® (bortezomib) and dexamethasone (Vd), resulting in a 7.6 month OS benefit (median OS 47.6 months for Kd56 versus 40.0 for Vd, HR=0.79; p=0.01). The OS benefit was consistent regardless of prior Velcade therapy (HR=0.75 for no prior Velcade; HR=0.84 for prior Velcade). This Kd56 regimen is already approved in the U.S., European Union and other countries based on the primary analysis of progression-free survival (PFS) in the ENDEAVOR study.

To view the multimedia assets associated with this release, please click: https://www.multivu.com/players/English/8004554-amgen-kyprolis-phase-3-endeavor-trial/

"These results showed KYPROLIS and dexamethasone significantly reduced the risk of death compared to Velcade and dexamethasone in patients with relapsed or refractory multiple myeloma," said study co-author and investigator Meletios A. Dimopoulos, M.D., professor of Clinical Therapeutics at the National and Kapodistrian University of Athens, School of Medicine. "These results support the use of KYPROLIS and dexamethasone as a standard of care for multiple myeloma patients at first relapse."

"In recent years, few clinical trials have demonstrated overall survival benefits in patients with relapsed or refractory multiple myeloma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "In ENDEAVOR, the only head-to-head trial comparing proteasome inhibitors, KYPROLIS showed a statistically significant overall survival benefit of 7.6 months over Velcade. These results published today in The Lancet Oncology support KYPROLIS as a superior proteasome inhibitor in relapsed multiple myeloma patients. We've shared these data with regulatory agencies in the U.S. and Europe to support a potential label update."

Adverse events observed in this updated analysis were consistent with those previously reported for ENDEAVOR. Notably, rates of grade 2 or higher peripheral neuropathy, a frequent dose-limiting toxicity of Velcade, were five-times lower in patients receiving Kd56 versus patients receiving Vd (7 percent versus 35 percent, respectively). The most common adverse events (greater than or equal to 20 percent) in the KYPROLIS arm were anemia, diarrhea, pyrexia, dyspnea, fatigue, hypertension, cough, insomnia, upper respiratory tract infection, peripheral edema, nausea, bronchitis, asthenia, back pain, thrombocytopenia and headache.

As previously published in The Lancet Oncology, patients treated with Kd56 also achieved PFS of 18.7 months compared to 9.4 months in those receiving Vd, meeting the primary endpoint of the study (HR=0.53; 95 percent CI: 0.44 – 0.65; p<0.0001).

Since its approval in 2012, KYPROLIS has been prescribed to over 50,000 patients worldwide. 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 Kd56 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 1 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 1 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 or the News Release section of Amgen.com.

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=2295334

Editor's Details

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

Last updated on: 25/08/2017

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