Phase 3 A.R.R.O.W. Study Of Once-Weekly KYPROLIS® (Carfilzomib) Regimen Meets Primary Endpoint Of Progression-Free Survival In Relapsed And Refractory Multiple Myeloma Patients

On October 23, 2017 Amgen (NASDAQ: AMGN) reported top-line results of the Phase 3 A.R.R.O.W. trial, which showed KYPROLIS (carfilzomib) administered once-weekly at the 70 mg/m2 dose with dexamethasone allowed relapsed and refractory multiple myeloma patients to live 3.6 months longer without their disease worsening than KYPROLIS administered twice-weekly at the 27 mg/m2 dose with dexamethasone (Press release, Amgen, OCT 23, 2017, View Source [SID1234521103]). The overall safety profile of the once-weekly KYPROLIS regimen was comparable to that of the twice-weekly regimen.

The study included 478 patients with relapsed and refractory multiple myeloma who received two or three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent (IMiD). Patients in the trial treated with the once-weekly KYPROLIS regimen achieved a statistically significant superior progression-free survival (PFS) with a median of 11.2 months compared to 7.6 months for those treated with the twice-weekly KYPROLIS regimen (HR = 0.69, 95 percent CI, 0.54 – 0.88).

“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. “We are encouraged by the efficacy and safety profile of KYPROLIS and dexamethasone administered once-weekly in the A.R.R.O.W. study.”

The most frequently reported treatment-emergent adverse events (greater than or equal to 20 percent) in either treatment arm were anemia, diarrhea, fatigue, hypertension, insomnia and pyrexia.