San Francisco, Calif.-based Onyx Pharmaceuticals has reached the target enrollment in the ASPIRE trial, a phase III international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid) and low-dose dexamethasone in patients with relapsed multiple myeloma.
Onyx has a Special Protocol Assessment (SPA) from the FDA and is currently being reviewed for New Drug Application (NDA) status to accelerate approval of carfilzomib in the U.S. Onyx has also received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the ASPIRE trial, which is ahead of schedule and should produce interim results as early as the first half of 2013.
The ASPIRE trial evaluates carfilzomib in combination with lenalidomide and low-dose dexamethasone, versus lenalidomide and low-dose dexamethasone alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens. The primary endpoint of the trial is progression-free survival. Secondary endpoints include overall survival, overall response rate, duration of response, disease control rate, safety, time-to-progression and time-to-next-treatment.
Patients will be randomized to receive carfilzomib (20mg/m2 on days 1 and 2 of cycle 1 only, then 27mg/m2 subsequently), in addition to a standard dosing schedule of lenalidomide (25mg per day for 21 days on, 7 days off) and low-dose dexamethasone (40mg per week in 4 week cycles), versus lenalidomide and low-dose dexamethasone alone. The study targeted enrollment of 780 patients and will be conducted at approximately 200 sites in North America, Europe and Israel.
The Prescription Drug User Fee Act (PDUFA) date for completion of the NDA review by the FDA is July 27, 2012.