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Celgene International Sàrl, a subsidiary of Celgene Corporation
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.”
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