Amgen's ASPIRE Trial Meets Primary Endpoint in Phase 3 for MM

The study evaluated carfilzomib in combination with Celgene's lenalidomide and dexamethasone.

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Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., today announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE (C A rfilzomib, Lenalidomide, and Dexametha S one versus Lenalidomide and Dexamethasone for the treatment of P at I ents with R elapsed Multiple My E loma) 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.

SourceL MarketWatch