Positive overall survival results for ASPIRE trial of Kyprolis for multiple myeloma
Amgen has announced new results showing the positive overall survival (OS) findings from the final analysis of the Phase III ASPIRE trial. The study met the key secondary endpoint of OS, demonstrating that the addition of Kyprolis (carfilzomib) to lenalidomide and dexamethasone (KRd) reduced the risk of death by 21 percent versus lenalidomide and dexamethasone alone (Rd) and extended survival by 7.9 months in patients with relapsed or refractory multiple myeloma (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 percent CI, 0.67 - 0.95; p = 0.0045). These results were presented during an oral presentation at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition in Atlanta (ASH abstract #743).
Comment: Based on the ASPIRE results, Amgen has submitted a supplemental New Drug Application to the FDA to include the OS data from ASPIRE in the product information for Kyprolis.
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