Results from the Phase III ASPIRE trial show that carfilzomib (Kyprolis®) in combination with lenalidomide (Revlimid®) and dexamethasone has a significant overall survival (OS) benefit in relapsed and refractory myeloma patients. Recently published in the Journal of Clinical Oncology, the results demonstrate that patients receiving carfilzomib, lenalidomide and dexamethasone had a median OS of 48.3 months, compared to 40.4 months for patients receiving lenalidomide and dexamethasone only.
In addition, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a label variation for carfilzomib, which includes OS survival data from the Phase III ENDEAVOUR trial. The results from this trial, published in The Lancet, demonstrate that relapsed and refractory myeloma patients who received carfilzomib and dexamethasone had a median OS of 47.6 months, compared to 40 months for patients receiving bortezomib (Velcade®) and dexamethasone. This label variation was also recently approved by the U.S. Food and Drug Administration (FDA).