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Amgen Inc announces top-line results from phase 3 focus trial of Kyprolis in patients with relapsed and advanced refractory multiple myeloma


Wednesday, 13 Aug 2014 04:01pm EDT 

Amgen Inc:Announced that Phase 3 clinical trial FOCUS did not meet its primary endpoint of improving overall survival (OS) (HR=0.975, 95 percent CI, 0.760, 1.249).Says 315-patient, open-label study evaluated single-agent Kyprolis (carfilzomib) for Injection compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma.Nearly all patients in control arm received cyclophosphamide.Patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry.Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms.Says rate of cardiac events observed in Kyprolis arm was consistent with the current U.S. Kyprolis label.Says there was an increase in incidence of renal adverse events of all grades observed in Kyprolis arm compared to the active control arm and label. 

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