Celgene's pomalidomide meets primary endpoint in multiple myeloma

US biotech major Celgene (Nasdaq: CELG) announced that positive updated results from MM-003, a Phase III multicenter, randomized open-label study (n=455) of pomalidomide (marketed as Pomalyst  in the USA and Imnovid in the European Union) plus low-dose dexamethasone, were published on-line ahead of print in The Lancet Oncology.

Results of the MM-003 trial formed the basis of the recent approval of pomalidomide by the European Medicines Agency in patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy (The Pharma Letter August 9).

The study compared oral pomalidomide plus low-dose dexamethasone with high-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma who have failed at least two prior therapies with both bortezomib and lenalidomide, administered alone or in combination.