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The latest results from an international Phase III clinical study, show that pomalidomide with low-dose dexamethasone improves the length of remission and extends overall survival in relapsed and refractory myeloma patients.

Pomalidomide, an immunomodulatory drug (IMiD) similar to Revlimid® and derived from thalidomide, is being developed by the pharmaceutical company Celgene as a potential treatment in myeloma.

The study known as NIMBUS (MM-003) involved patients who had relapsed or who had not responded to at least two previous treatments. Patients received either pomalidomide and low-dose dexamethasone or high-dose dexamethasone only.

Celgene’s announcement of the results also included conclusions drawn by the data safety monitoring committee, which recommend patients in the high-dose dexamethasone group, who had not progressed, be moved to the pomalidomide plus low-dose dexamethasone group. The committee also found that the side-effects in the study were consistent with those reported from other pomalidomide studies involving myeloma patients.

Pomalidomide has recently been submitted to the European Medicines Agency (EMA) for licensing approval as a treatment for myeloma. A decision is anticipated in the second half of 2013.

Sarper Diler MPE chairman said, “These results are very promising and we look forward to additional data being presented at the American Society of Haematology Conference in December. The data bodes well and hopefully will strengthen the application for pomalidomide to become available as a much-needed new treatment for myeloma patients.”

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