Amgen's Kyprolis failed to meet primary endpoint in multiple myeloma trial

USA-based Amgen (Nasdaq: AMGN), the world’s leading independent biotech firm, and its subsidiary Onyx Pharmaceuticals, have said that their Phase III trial of Kyprolis (carfilzomib) in the treatment of advanced refractory multiple myeloma did not meet its primary endpoint.

The study compared single-agent Kyprolis for injection to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma. The incidence of treatment discontinuation due to adverse events and deaths on-study were comparable between both arms, and the rate of cardiac events observed in the Kyprolis arm was consistent with its current US labelling. The Kyprolis arm, however, showed an increase in the incidence of adverse renal events of all grades, compared to the active control arm and its labelling.

Patients were heavily pre-treated and had received a median of five therapeutic regimens prior to entering the study.