Celgene's pomalidomide meets MM-003 study endpoints

US biotech firm Celgene’s (Nasdaq: CELG) European subsidiary yesterday revealed that its phase III, multi-center, randomized, open-label study (MM-003) of pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma met the primary endpoint of improvement in progression-free survival (PFS) as reviewed by a data safety monitoring board (DSMB).

Additionally, at the OS interim analysis, the study crossed the superiority boundary for overall survival (OS), a key secondary endpoint that the study was also powered to evaluate. Improvements in PFS and OS were both highly statistically significant and clinically meaningful. As a result, the DSMB recommended that patients who had not yet progressed in the high-dose dexamethasone arm should be crossed-over to the pomalidomide plus low-dose dexamethasone arm.

Safety results observed in MM-003 were consistent with previous studies of pomalidomide in relapsed/refractory multiple myeloma patients. Full data from the study are being prepared for submission to a future medical meeting for presentation.