Amgen announced that the Journal of Clinical Oncology published positive overall survival (OS) findings from the final analysis of the Phase 3 ASPIRE trial, which demonstrated that the addition of KYPROLIS® (carfilzomib) to lenalidomide and dexamethasone reduced the risk of death by 21% versus lenalidomide and dexamethasone alone (Rd) and extended OS by 7.9 months in patients with relapsed or refractory multiple myeloma. Notably, an OS improvement of 11.4 months was observed for patients at first relapse, supporting early use of KRd. The safety data from ASPIRE was consistent with the known safety profile of KYPROLIS. The most common adverse events 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. The final analysis of ASPIRE included subgroup analyses by prior lines of therapy, prior Velcade® (bortezomib) exposure at first relapse, and prior transplant at first relapse. Among these three groups, there was an 18% to 29% reduction in the risk of death for KRd versus Rd, consistent with findings in the overall population. Median OS was 11.4 months longer for KRd versus Rd in patients who had received one prior line of therapy and 6.5 months longer for patients with two or more prior lines. Among patients who had received one prior line, median OS was improved by 12 months with KRd versus Rd in those with prior Velcade exposure and by 7.9 months in those without prior Velcade. Median OS was also improved by 18.6 months with KRd versus Rd among patients with prior transplantation at first relapse. The KRd regimen used in this trial is currently approved in the U.S., European Union and other countries based on primary analysis of progression-free survival (PFS) in the ASPIRE study. Amgen has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration and a variation to the marketing application to the European Medicines Agency to include the OS data from ASPIRE in the product information for KYPROLIS.