USA-based Amgen (Nasdaq: AMGN), the world’s leading independent biotech firm, and its subsidiary Onyx say their Phase III trial of Kyprolis (carfilzomib) in combination with Revlimid (lenalidomide) and low-dose dexamethasone has met its primary endpoint of progression-free survival in multiple myeloma.
The trial compared this combination against patients treated with Revlimid and low-dose dexamethasone. The data showing overall survival, a secondary endpoint of the trial, are not yet mature, but analysis showed a trend that did not reach statistical significance. Treatment discontinuation due to adverse events and on-study deaths were comparable in both arms of the trial, and no new safety signals were detected.
Robert Bradway, chief executive of Amgen, said: "Kyprolis is an important building block in our robust, differentiated pipeline. Coupled with our recent US regulatory submissions for ivabradine and talimogene laherparepvec and our upcoming regulatory submissions for evolocumab and blinatumomab, our pipeline continues to show notable progress."
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