Amgen's Kyprolis meets OS endpoint in Phase III ASPIRE trial for MM
Amgen Inc. (NASDAQ:AMGN) reported additional data from the Phase III ASPIRE trial in 792 patients with relapsed or refractory multiple myeloma (MM) following treatment with 1-3 prior regimens showing that Kyprolis carfilzomib (PR-171, ONO-7057) plus Revlimid lenalidomide and low-dose dexamethasone met the secondary endpoint of improving overall survival (OS) vs. Revlimid and low-dose dexamethasone alone (48.3 vs. 40.4 months, HR=0.79, 95% CI: 0.67, 0.95, p=0.0045). Data were presented at the American Society of Hematology meeting in Atlanta in December.
Amgen said it has submitted an sNDA to FDA to include ASPIRE's OS data on the drug's label. The company has previously reported that the Kyprolis arm met the primary endpoint of improving median progression-free survival (PFS) and the secondary endpoint of improving overall response rate (ORR) in ASPIRE (see BioCentury, Aug. 11, 2014 & Dec 15, 2014)...