Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) 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% 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 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.”
Results from the ASPIRE study will form the basis for regulatory submissions throughout the world beginning in the first half of 2015. In the U.S., the data may support the conversion of accelerated approval to full approval and expand the current indication.
“In the treatment of patients with multiple myeloma, periods of remission become shorter following each treatment regimen, underscoring the need for new options. The results of the ASPIRE study demonstrate that Kyprolis can significantly extend the time patients live without their disease progressing,” said Pablo Cagnoni, president, Onyx Pharmaceuticals Inc. “The ability of novel therapies to produce deep and durable responses may, one day, transform this uniformly fatal disease to one that is chronic and manageable.”
Onyx conducted the ASPIRE study under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) and has received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the study.
Date: August 4, 2014