Celgene Corp. (CELG) is having a solid month in drug development. Earlier in October, the company reported the U.S. Food and Drug Administration approved its ABRAXANE® for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
On Tuesday morning, the Summit, New Jersey-based biotech said that its Phase III multi-center clinical trial, called MM-003, of pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma has met its primary endpoint of progression-free survival. The drug cocktail is being developed by Celgene International Sàrl, a Swiss subsidiary of Celgene Corp. Analysis of interim data initially shows that the study also improved overall survival, a key secondary endpoint. Safety results were consistent with previous clinical trials.
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a blood cancer of unknown causes in which malignant plasma cells are overproduced in the bone marrow. Patients in the MM-003 study were relapsed on or refractory to at least two prior therapies that must have included both lenalidomide and bortezomib.
The improvements in progression-free survival and overall survival were “highly statistically significant and clinically meaningful,” according to the Celgene.
“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,” said Dr. Jesus San Miguel, principal investigator in the MM-003 study.
Because of the findings, the data safety monitoring board that reviewed the information has recommended that patients who had not yet progressed in the high-dose dexamethasone arm should be transitioned to the pomalidomide plus low-dose dexamethasone arm.
Celgene said it submitted a Marketing Authorisation Application for pomalidomide in combination with dexamethasone to the European Medical Association in May and added that it anticipates a decision by EMA in the second half of 2013. Stateside, a new drug application has been accepted for review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of Feb. 10, 2013.
Full data from the study are being prepared for submission to a future medical meeting for presentation, according to today’s statement.
Celgene is slated to release its third quarter earnings on Thursday, October 25. Wall Street is expecting a profit of $1.16 per share, a nearly 20 percent rise compared to the year prior quarter. In the second quarter, the company topped estimates by reporting profit of $1.10 per share, against analyst calls for $1.06 per share.