Amgen announces 'positive' results from final analysis of Phase 3 ASPIRE trial
Amgen announced positive results from the final analysis of the Phase 3 ASPIRE trial. The study met the key secondary endpoint of overall survival, demonstrating that KYPROLIS, lenalidomide and dexamethasone reduced the risk of death by 21% over lenalidomide and dexamethasone alone (Rd) (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 percent 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 27 mg/m2 is currently approved in the U.S., European Union and other countries based on the primary analysis of progression-free survival in the ASPIRE study. Adverse events observed in this updated analysis were consistent with those previously reported for ASPIRE. The most common adverse events (greater than or equal to 20%) in the KYPROLIS arm were diarrhea, anemia, neutropenia, fatigue, upper respiratory tract infection, pyrexia, cough, hypokalemia, thrombocytopenia, muscle spasms, pneumonia, nasopharyngitis, nausea, constipation, insomnia and bronchitis.