Date: 2016-02-15
Type of information: Results
phase: 3
Announcement: results
Company: Amgen (USA - CA)
Product: Aranesp® (darbepoetin alfa)
Action mechanism: erythropoietin/erythropoiesis-stimulating agent (ESA)
Disease: anemic patients with low and intermediate-1 risk myelodysplastic syndrome (MDS)
Therapeutic area: Cancer - Oncology
Country:
Trial details: The Phase 3 ARCADE trial was a multicenter, randomized, double-blind, placebo-controlled study evaluating Aranesp in 146 patients with low or intermediate-1 risk MDS who had not previously taken ESAs or biologic response modifiers. During a 24-week period, patients received either Aranesp 500 ?g (n=97) or placebo (n=49) every three weeks. At week 25, when the primary and key secondary endpoints were assessed, patients underwent an end-of-treatment period (EOTP) visit and could subsequently enter a 48-week active treatment period where all participants crossed over to receive Aranesp, with dose escalation allowed beginning on week 31. Treatment continued until week 72 or 73, and long-term follow up continues to occur every 26 weeks, for a minimum of three years.
Latest news: * On February 15, 2016, Amgen announced that the randomized, double-blind, placebo-controlled Phase 3 Aranesp® (darbepoetin alfa) ARCADE trial met its primary endpoint of reducing the incidence of red blood cell transfusions in anemic patients with low and intermediate-1 risk MDS at the end of the blinded 25-week study period. Aranesp® also significantly improved erythroid response, a key measure of the formation of new red blood cells. Detailed results will be submitted to a future medical conference and for publication. Safety data was consistent with the known safety profile of Aranesp, and the adverse events were generally balanced between treatment arms. The adverse events reported in the Aranesp arm at least five percent more frequently than in the placebo group were fatigue, pyrexia, headache and myalgia.
