Favorable Results of ASPIRE Clinical Trial Announced

Following favorable results of the ASPIRE clinical trial, Amgen acquired Onyx Pharmaceuticals for an estimated $9.7 billion.

Interim results of the phase 3 ASPIRE clinical trial evaluating treatments for patients with relapsed multiple myeloma have been released by scientists affiliated with Onyx pharmaceuticals.¹

The trial evaluated the use of lenolidomide, low-dose dexamethasone, and carfilzomib in patients with multiple myeloma compared with control patients receiving lenolidomide, low-dose dexamethasone, and a placebo. Overall survival was significantly longer (26.3 months versus 17.6 months; P <.0001) in patients receiving carfilzomib instead of placebo. In addition, the risk of disease progression was 31% lower with use of carfilzomib.¹

Regarding the favorable results, Onyx Pharmaceuticals, Inc president Pablo J Cagnoni, MD, stated, "The results of the ASPIRE study demonstrate that Kyprolis can significantly extend the time patients live without their disease progressing."¹

Shortly after the announcement of these results, Amgen bought Onyx pharmaceuticals for $9.7 billion.² In a statement, Amgen chairman and chief executive officer Robert A. Bradway stated, "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."¹

Kyprolis was initially approved by the FDA in 2012 for use in patients with multiple myeloma who had experienced a relapse after 2 lines of prior therapy, including bortezomib. Use of carfilzomib has been associated with cardiac complications, pulmonary hypertension, infusion reactions, tumor lysis syndrome, thrombocytopenia, and hepatic toxicity/liver failure.³

References:

• Onyx Pharmaceuticals. Amgen Announces Phase 3 ASPIRE Trial of Kyprolis in Patients with Relapsed Multiple Myeloma Met Primary Endpoint. http://www.onyx.com/view.cfm/714/amgen-announces-phase-3-aspire-trial-of-kyprolis-in-patients-with-relapsed-multiple-myeloma-met-primary-endpoint-. Accessed August 2014.
• Amgen Pharmaceuticals. Amgen Successfully Completes Onyx Pharmaceuticals Tender Offer. http://www.amgen.com/media/media_pr_detail.jsp?releaseID=1860143. Accessed August 2014.
• KYPROLIS (carfilzomib) [package insert]. South San Francisco, CA: Onyx Pharmaceuticals, Inc; 2012.