onyx Pharmaceuticals has completed patient enrolment in the Carfilzomib, Lenalidomide and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma (ASPIRE) trial.
The trial enrolled 780 patients at approximately 200 sites to evaluate Carfilzomib in combination with lenalidomide (Revlimid) and low dose dexamethasone in patients with relapsed multiple myeloma.
In the study, patients were randomised to receive Carfilzomib 20mg/m2 and 27mg/m2, in addition to a standard dosing schedule of lenalidomide 25mg per day and low-dose dexamethasone 40mg per week compared to lenalidomide and low-dose dexamethasone alone.
The primary endpoint of the trial is progression-free survival, while the secondary endpoints include overall survival, overall response rate, duration of response, disease control rate, safety, time-to-progression and time-to-next treatment.
Onyx Pharmaceuticals executive vice president Ted Love said the ASPIRE trial will support full approval of Carfilzomib for use in patients with relapsed multiple myeloma.
"We are pleased to have completed enrolment in the ASPIRE study ahead of schedule, and could have interim results as early as the first half of 2013," Love added.
The previous Phase 1/2 dose-escalation trial demonstrated Carfilzomib in combination with lenalidomide and low dose dexamethasone in patients with relapsed and/or refractory myeloma, while the open-label, single-arm Phase 2b study investigated heavily pre-treated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies.
Currently, Carfilzomib is being studied in a Phase 3 FOCUS trial, which is designed to assess the drug in patients with relapsed and refractory myeloma who have received three or more prior therapies.
Onyx’s partner Ono Pharmaceutical is also conducting a Phase 1/2 study for examining Carfilzomib in Japanese patients with relapsed/refractory multiple myeloma.
The FDA is now reviewing a New Drug Application (NDA) for accelerated approval of Carfilzomib in the US for the treatment of patients with relapsed and refractory multiple myeloma, which is scheduled for completion in July 2012.
Based in California, US, Onyx Pharmaceuticals is a global biopharmaceutical company focused on the development and commercialisation of innovative therapies for improving the lives of people with cancer and other serious diseases.