Significant survival improvement shown by Kyprolis Phase III trial in myeloma

US biotech major Amgen (Nasdaq: AMGN) has announced positive results from the final analysis of the Phase III ASPIRE trial, confirming results of the previous ENDEAVOR study.

The study met the key secondary endpoint of overall survival (OS), demonstrating that Kyprolis (carfilzomib), lenalidomide and dexamethasone (KRd) reduced the risk of death by 2%1 over lenalidomide and dexamethasone alone (Rd) (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95% CI, 0.67 – 0.95). Per protocol, patients received 18 cycles of Kyprolis with Rd before continuing treatment with Rd alone to progression. This KRd regimen of twice-weekly Kyprolis administered at 27mg/m2 is currently approved in the USA, European Union and other countries based on the primary analysis of progression-free survival (PFS) in the ASPIRE study.

‘Should be considered a new standard of care’