Success for Pomalyst/Imnovid plus bortezomib and low-dose dexamethasone by improving PFS inOPTIMISMM trial for multiple myeloma.

Celgene Corporation announced that the Phase III, randomized, open-label, international clinical study, OPTIMISMM, achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the pomalidomide arm versus the comparator arm.

OPTIMISMM evaluated the efficacy and safety of Pomalyst/Imnovid (pomalidomide) plus bortezomib and low-dose dexamethasone (PVd) versus bortezomib and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma. It is the only phase III trial to investigate a triplet combination in patients who have all received prior lenalidomide (REvlimid), a population for which there is a growing unmet medical need.

In the study, the safety profile was consistent with previously reported data. Detailed data from OPTIMISMM will be presented at future medical meetings. The combination of Pomalyst/Imnovid, bortezomib and low-dose dexamethasone is not currently approved for use.