Phase 3 clinical trials ASPIRE meets primary endpoint of progression-free survival -
Amgen (NASDAQ: AMGN) and its subsidiary, Onyx Pharmaceuticals, Inc., announced today than planned interim analysis showed that the clinical trial phase 3 ASPIRE (C a rfilzomib, lenalidomide and Dexametha S against a lenalidomide and dexamethasone for the treatment of P to I ents with R up multiple My E loma) has 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) significantly lived 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 = 0.60, 95 percent Cl, 0.570, 0.834, p <0.0001). Although 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 label Kyprolis US, including the rate of cardiac events. Discontinuation due to adverse events and the death of the study were comparable between the two arms. No new safety signals were identified.
The results will be submitted for presentation at the upcoming 56th Annual Meeting of the American Society of Hematology later this year.
"We are delighted to these clinical results and the positive outlook they suggest for multiple myeloma patients," said Robert A. Bradway, president and CEO of Amgen, adding, "our mission at Amgen is to serve patients by advancing medicines that treat serious. Kyprolis diseases is an important building block in our robust differentiated pipeline."
Bradway further explained, "Coupled with our recent US regulatory submissions for ivabradine and talimogene laherparepvec and our regulatory submissions coming for evolocumab and blinatumomab, our pipeline continues to show significant progress. "
the results of the ASPIRE study will form the basis for regulatory submissions worldwide from the first half of 2015 in the US, the data may support the conversion of accelerated approval of full approval and expand the current indication.
"In the treatment of multiple myeloma patients, remissions become shorter after each treatment regimen, which underlines the need for new options. The results of the ASPIRE study demonstrate that Kyprolis can significantly extend the time patients live without disease progression, "said Pablo J. Cagnoni, MD, President, Onyx Pharmaceuticals, Inc." the ability of new therapies to produce profound and lasting responses may one day , turn this uniformly fatal disease to one that is chronic and manageable. "
Onyx led the ASPIRE study under a special Protocol assessment (SPA) from the US Food and Drug administration (FDA) and received scientific Council of the European medicines Agency (EMA) on the design and planned analysis of the study.
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