http://www.raredr.com/news/phase-3-arrow-study-meets-primary-endpoint
Phase 3 ARROW Study of Kyprolis Meets Primary Endpoint in Multiple Myeloma Patients

Mathew Shanley

A new dosing regimen for Amgen’s multiple myeloma drug Kyprolis (carfilzomib) appears to be more effective than what is currently approved.

On Tuesday, the company announced top-line data from the Phase 3 A.R.R.O.W. trial (RAndomized, Open-label, Phase 3 Study in Subjects with Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination with Dexamethazone, Comparing Once-Weekly versus Twice-weekly Carfilzomib Dosing), exhibiting that dosing Kyprolis once-weekly, rather than twice-weekly as currently indicated, led to an additional 3.6 months of living without cancer progression.

The proteasome inhibitor improved progression-free survival (PFS) by 3.6 months in patients with relapsed and refractory multiple myeloma when given once-weekly at a 70 mg/m2 dose with dexamethasone compared to when the drug was administered twice-weekly at the 27 mg/m2 dose with dexamethasone.

Multiple myeloma forms in the plasma cells, causing cancer to accumulate in the bone marrow. Symptoms most commonly include bone pain, nausea, constipation, loss of appetite, cognitive impairment, and excessive thirst. In August, Amgen announced impressive results from its 3-year post hoc analysis.
Per the National Cancer Institute, approximately 30,280 Americans are diagnosed with multiple myeloma each year, and 12,590 patient deaths are reported annually.

"Kyprolis has been demonstrated to be the most effective proteosome inhibitor available to patients with multiple myeloma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen in a press release. "We are encouraged by the efficacy and safety profile of KYPROLIS and dexamethasone administered once-weekly in the A.R.R.O.W. study."

In the study, 478 patients with relapsed and refractory multiple myeloma who had received either 2 or 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, were enrolled and treated with Kyprolis. Data showed that patients in the trial treated with the once-weekly Kyprolis regimen experienced a median PFS of 11.2 months; a significant upgrade compared to the 7.6 months PFS achieved by those treated with the twice-weekly regimen.

The multi-center A.R.R.O.W. trial had secondary endpoints including overall response rates, overall survival (OS), safety and tolerability. The most frequently reported adverse events (AEs) related to treatment in either cohort were anemia, diarrhea, fatigue, hypertension, insomnia, and pyrexia.

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