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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-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma was reviewed by a data safety monitoring board (DSMB). The DSMB determined MM-003 met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis. Additionally, at the OS interim analysis, the study crossed the superiority boundary for overall survival (OS), a key secondary endpoint that the study was also powered to evaluate. Improvements in PFS and OS were both highly statistically significant and clinically meaningful. As a result, the DSMB recommended that patients who had not yet progressed in the high-dose dexamethasone arm should be crossed-over to the pomalidomide plus low-dose dexamethasone arm.

Safety results observed in MM-003 were consistent with previous studies of pomalidomide in relapsed/refractory multiple myeloma patients. Full data from the study are being prepared for submission to a future medical meeting for presentation.

“The survival results in this study build on earlier observations of high response rates for pomalidomide and dexamethasone in multiple myeloma patients who had been exposed to multiple therapies, including immunomodulatory agents and proteasome inhibitors,” said Dr. Jesus San Miguel, Head of the Department of Hematology at the University of Salamanca, Director of the Biomedical Research Institute of Salamanca and principal investigator in the study. “The continued progress of new agents in this area of disease, particularly in later-stage patients is critical as we look to extend remissions and survival for these individuals.”

Posted-In: News FDA

 

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