Amgen's Phase III Trial Of Kyprolis Meets Primary Endpoint

Amgen announced in a press release that an interim analysis of its Phase III trial of Kyprolis (carfilzomib) for relapsed multiple myeloma met its primary endpoint. In the ASPIRE trial, patients treated with Kyprolis, Revlimid (lenalidomide), and low-dose dexamethasone lived significantly longer, meeting the endpoint of progression-free survival (PFS). Amgen intends to use the results in regulatory filings worldwide beginning in 2015 and present the findings at the upcoming 56th Annual Meeting of the American Society of Hematology.

In the U.S., Onyx Pharmaceuticals, an Amgen subsidiary, markets Kyprolis. Pablo J. Cagnoni, M.D., president of Onyx Pharmaceuticals, said, "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.”

Kyprolis

Kyprolis (carfilzomib) is a proteasome inhibitor engineered for injection. It was granted a Food and Drug Administration (FDA) accelerated approval in July 2012 for patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD) and who have demonstrated disease progression on or within 60 days of completion of the last therapy. The FDA based its approval on response rate; survival times and diminishment of symptoms were not proven.

Kyprolis Phase III Study

Onyx conducted the Kyprolis Phase III ASPIRE Study, “CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma.” The trial was approved under a Special Protocol Assessment (SPA) from the FDA, and the European Medicines Agency (EMA) contributed to the design and analysis of the study. Patients treated with Kyprolis, Revlimid, and dexamethasone lived an average 26 months longer compared to patients treated with Revlimid and dexamethasone, who lived an average 18 months longer. Secondary endpoint data is not yet ready. The safety data collected is similar to the findings in the current U.S. label, with no new safety issues identified.

Amgen’s Pipeline

Robert A. Bradway, chairman and CEO of Amgen, said that Amgen’s pipeline shows “notable progress.” The company has filed regulatory submissions for ivabradine and talimogene laherparepvec and is preparing submissions for evolocumab and blinatumomab.

In July 2014, Amgen announced that a Phase III study of AMG 416 (formerly known as velcalcetide) met its primary and secondary endpoints when treating secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis.