Amgen: Phase 3 Study In Multiple Myeloma Meets Primary Goal

(RTTNews) - Biotechnology firm Amgen Inc. (AMGN) and its subsidiary, Onyx Pharmaceuticals, Inc. (ONXX), Monday said 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 or PFS.

Patients treated with Kyprolis (carfilzomib) for Injection in combination with Revlimid (lenalidomide) and low-dose dexamethasone or KRd lived significantly longer without their disease worsening compared to patients treated with Revlimid and low-dose dexamethasone or Rd.

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.

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.

Onyx conducted the ASPIRE study under a Special Protocol Assessment from the U.S. Food and Drug Administration and has received Scientific Advice from the European Medicines Agency on the design and planned analysis of the study.

AMGN, which closed down 1.4 percent at $125.55 on Friday, climbed 4.8 percent in pre-market activity.