Amgen has announced disappointing results from their phase 3 study, Carfilzomib for Advanced Refractory Multiple Myeloma European Study (FOCUS) as carfilzomib (Kyprolis) did not reach its primary endpoint for the treatment of refractory multiple myeloma.
The phase 3, open-label study assessed carfilzomib versus a regimen of low-dose dexamethasone plus optional cyclophosphamide for the treatment of patients with multiple myeloma who have received at least three prior therapies.
The study, which included 315 patients, showed that carfilzomib did not improve overall survival, their primary endpoint. Secondary endpoints consisted of clinical benefit rate, duration of response, overall response rate, progression-free survival, and safety. The study demonstrated an increased risk of nephrotoxicity in those that were randomized to carfilzomib.
Despite the setback, Amgen is optimistic that it will receive approval for its drug based on the positive phase 3 ASPIRE study, which evaluated the efficacy and safety of carfilzomib plus lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma.
Kyprolis, a selective proteasome inhibitor, was granted accelerated approval by the U.S. Food and Drug Administration for the treatment of patients with multiple myeloma who have received at least two prior treatments, including bortezomib and an immunomodulatory agent.
Amgen suffered a major setback when FOCUS did not meet its primary endpoint.
Amgen (AMGN) suffered a major setback when its phase III study, FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study) on multiple myeloma treatment, Kyprolis did not meet its primary endpoint.
The open-label study evaluated Kyprolis versus an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients suffering from relapsed and advanced refractory multiple myeloma.
However, the study did not meet its primary endpoint of improving overall survival (:OS). The results from the study showed that there was an increase in the incidence of renal adverse events of all grades in the Kyprolis arm compared to the active control arm and the label.
From Yahoo News
