Low-dose dexamethasone with pomalidomide improved overall survival to 12.7 months, compared to 5.7 months with high-dose dexamethasone.
elgene International Sàrl, a wholly-owned subsidiary of Celgene Corp., announced that a retrospective analysis of MM-003, the company’s Phase 3 study of pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone in patients with refractory multiple myeloma who have failed therapy with both bortezomib and lenalidomide, administered either alone or in combination, were presented at the 19th European Hematology Association annual congress. Pomalidomide is marketed as Pomalyst in the United States and Imnovid in the European Union.
The primary data from the MM-003 trial have been previously reported (San Miguel et al, Lancet Oncology 2013). However, due to IDMC assessment of the final PFS analysis, more than 50% of the patients who received high-dose dexamethasone during the study crossed over to receive subsequent pomalidomide plus low-dose dexamethasone. As such, the goal of this retrospective analysis was to estimate the difference in overall survival between the two arms of the study after adjusting for those patients who crossed over and received subsequent pomalidomide plus low-dose dexamethasone.
Source: Drug Discovery and Development Magazine