Celgene says phase III study of pomalidomide combo met primary endpoint

A wholly-owned subsidiary of Celgene Corporation announced that updated results from MM-003, a phase III multi-center, randomized open-label study of pomalidomide plus low-dose dexamethasone, were published online ahead of print in The Lancet Oncology. 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. At the interim analysis, the study met its primary endpoint as pomalidomide plus low-dose dexamethasone demonstrated a significant improvement in progression-free survival compared with high-dose dexamethasone. There was also a significant improvement in the key secondary endpoint of overall survival compared with high-dose dexamethasone even though 45 patients in the high-dose dexamethasone arm crossed over and received pomalidomide. Additionally, the Data Monitoring Committee recommended that patients who had not yet progressed in the high-dose dexamethasone arm should have access to pomalidomide with or without low-dose dexamethasone.

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