Celgene Reports Phase III Results

Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG)today announced that its phase III, multi-center, randomized, open-label study(MM-003) of pomalidomide plus low-dose dexamethasone compared to high-dosedexamethasone in patients with relapsed and/or refractory multiple myeloma wasreviewed by a data safety monitoring board (DSMB). The DSMB determined MM-003met the primary endpoint of improvement in progression-free survival (PFS) atthe PFS final analysis. Additionally, at the OS interim analysis, the studycrossed the superiority boundary for overall survival (OS), a key secondaryendpoint that the study was also powered to evaluate. Improvements in PFS andOS were both highly statistically significant and clinically meaningful. As aresult, the DSMB recommended that patients who had not yet progressed in thehigh-dose dexamethasone arm should be crossed-over to the pomalidomide pluslow-dose dexamethasone arm.Safety results observed in MM-003 were consistent with previous studies ofpomalidomide in relapsed/refractory multiple myeloma patients. Full data fromthe study are being prepared for submission to a future medical meeting forpresentation.“The survival results in this study build on earlier observations of highresponse rates for pomalidomide and dexamethasone in multiple myeloma patientswho had been exposed to multiple therapies, including immunomodulatory agentsand proteasome inhibitors,” said Dr. Jesus San Miguel, Head of the Departmentof Hematology at the University of Salamanca, Director of the BiomedicalResearch Institute of Salamanca and principal investigator in the study. “Thecontinued progress of new agents in this area of disease, particularly inlater-stage patients is critical as we look to extend remissions and survivalfor these individuals.”