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Amgen Announces Phase 3 ASPIRE Trial Of Kyprolis® In Patients With Relapsed Multiple Myeloma Met Primary Endpoint

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Aug. 4, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and its subsidiary, Onyx Pharmaceuticals, Inc., today announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE (C Arfilzomib, Lenalidomide, and Dexametha Sone versus Lenalidomide and Dexamethasone for the treatment of Pat Ients with Relapsed Multiple My Eloma) met its primary endpoint of progression-free survival (PFS). Patients treated with Kyprolis ® (carfilzomib) for Injection in combination with Revlimid ® (lenalidomide) and low-dose dexamethasone (KRd) lived significantly longer without their disease worsening (median 26.3 months) compared to patients treated with Revlimid and low-dose dexamethasone (Rd) (median 17.6 months) (HR=0.690, 95 percent CI, 0.570, 0.834, p<0.0001). While the data for overall survival, a secondary endpoint, are not yet mature, the analysis showed a trend in favor of KRd that did not reach statistical significance.

The safety profile observed in this study is consistent with the current U.S. Kyprolis label, including the rate of cardiac events. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. No new safety signals were identified.

Results will be submitted for presentation at the upcoming 56th Annual Meeting of the American Society of Hematology later this year.

"We are excited about these clinical results and the positive prospects they suggest for patients with multiple myeloma," said Robert A. Bradway, chairman and chief executive officer of Amgen, adding, "Our mission at Amgen is to serve patients by advancing medicines that address serious disease. Kyprolis is an important building block in our robust, differentiated pipeline."

Bradway further explained, "Coupled with our recent U.S. 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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