Amgen Says Phase 3 Focus Trial Fails To Meet Primary Endpoint

(RTTNews) - Amgen Inc. (AMGN) and its subsidiary, Onyx Pharmaceuticals, Inc., said Wednesday that the Phase 3 clinical trial FOCUS did not meet its primary endpoint of improving overall survival.

The 315-patient, open-label study evaluated single-agent Kyprolis 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 the 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. The rate of cardiac events observed in the Kyprolis arm was consistent with the current U.S. Kyprolis label. There was an increase in the incidence of renal adverse events of all grades observed in the Kyprolis arm compared to the active control arm and the label.