Amgen's Kyprolis meets in Phase III ASPIRE trial

An interim analysis showed Kyprolis carfilzomib from Amgen Inc. (NASDAQ:AMGN) plus Revlimid lenalidomide and low-dose dexamethasone met the primary endpoint of improving median progression-free survival (PFS) vs. Revlimid and low-dose dexamethasone alone in the Phase III ASPIRE trial to treat relapsed multiple myeloma (26.3 vs. 17.6 months, p<0.0001). Data for the secondary endpoint of overall survival (OS) are not yet mature, but show a trend in favor of the Kyprolis arm. The safety profile in ASPIRE, including the rate of cardiac events, was consistent with the Kyprolis U.S. label.

The open-label, international trial enrolled 792 patients with relapsed MM following treatment with one to three prior regimens. Onyx Pharmaceuticals Inc., which Amgen acquired in 2013, was required to complete ASPIRE as part of a 2012 accelerated approval for Kyprolis to treat MM in patients who have received at least two prior therapies. Based on the data, Amgen plans to submit regulatory applications worldwide beginning in 1H15. ...