Study met its primary endpoint demonstrating significant improvement in progression-free survival (PFS) with POMALYST®/IMNOVID® in combination with bortezomib and dexamethasone (PVd) compared with bortezomib and low-dose dexamethasone
SUMMIT, NJ, USA I February 6, 2018 I Celgene Corporation (NASDAQ:CELG) today announced that the Phase III, randomized, open-label, international clinical study, OPTIMISMM, achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the pomalidomide arm versus the comparator arm.
OPTIMISMM evaluated the efficacy and safety of POMALYST/IMNOVID (pomalidomide) plus bortezomib and low-dose dexamethasone (PVd) versus bortezomib and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma. It is the only phase III trial to investigate a triplet combination in patients who have all received prior lenalidomide (REVLIMID®), a population for which there is a growing unmet medical need.
“The OPTIMISMM results confirm the expanding role of pomalidomide in previously treated multiple myeloma patients,” said Paul Richardson, M.D., Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center at the Dana Farber Cancer Institute, RJ Corman Professor of Medicine, Harvard Medical School and principal investigator of the study. “We see the PVd combination as an important step in improving care, and especially for patients previously treated with lenalidomide in this setting.”
In the study, the safety profile was consistent with previously reported data. Detailed data from OPTIMISMM will be presented at future medical meetings.
The combination of POMALYST/IMNOVID, bortezomib and low-dose dexamethasone is not currently approved for use.
About POMALYST/IMNOVID
Indication
POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Please see full Prescribing Information, including Boxed WARNINGS.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
SOURCE: Celgene
Post Views: 29
Study met its primary endpoint demonstrating significant improvement in progression-free survival (PFS) with POMALYST®/IMNOVID® in combination with bortezomib and dexamethasone (PVd) compared with bortezomib and low-dose dexamethasone
SUMMIT, NJ, USA I February 6, 2018 I Celgene Corporation (NASDAQ:CELG) today announced that the Phase III, randomized, open-label, international clinical study, OPTIMISMM, achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the pomalidomide arm versus the comparator arm.
OPTIMISMM evaluated the efficacy and safety of POMALYST/IMNOVID (pomalidomide) plus bortezomib and low-dose dexamethasone (PVd) versus bortezomib and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma. It is the only phase III trial to investigate a triplet combination in patients who have all received prior lenalidomide (REVLIMID®), a population for which there is a growing unmet medical need.
“The OPTIMISMM results confirm the expanding role of pomalidomide in previously treated multiple myeloma patients,” said Paul Richardson, M.D., Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center at the Dana Farber Cancer Institute, RJ Corman Professor of Medicine, Harvard Medical School and principal investigator of the study. “We see the PVd combination as an important step in improving care, and especially for patients previously treated with lenalidomide in this setting.”
In the study, the safety profile was consistent with previously reported data. Detailed data from OPTIMISMM will be presented at future medical meetings.
The combination of POMALYST/IMNOVID, bortezomib and low-dose dexamethasone is not currently approved for use.
About POMALYST/IMNOVID
Indication
POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Please see full Prescribing Information, including Boxed WARNINGS.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
SOURCE: Celgene
Post Views: 29
