ts with desired response in the Phase II study. The secondary outcome measures will include finding the number of participants with progression free survival (PFS) and the number of participants with overall survival (OS) after 24 months.
The FDA approval for the drug was based on the results from a Phase II clinical trial known as CC-4047-MM-002 study. It was a randomised, open label, multicentre study which enrolled 221 patients with relapsed and refractory multiple myeloma and previously treated with lenalidomide and bortezomib therapies. The treatment arms of the study included pomalidomide alone or pomalidomide plus low-dose dexamethasone.
The results of the study showed that the overall response rate in patients who were treated with pomalidomide alone was seven percent, whereas the response rate was 29% in the pomalidomide plus low-dose dexamethasone patients group. The median response rate in the pomalidomide plus low-dose dexamethasone arm was 7.4 months, but it was not eva luable in pomalidomide alone arm.
Celgene initiated a Phase III clinical trial on pomalyst in March 2011. It was an open label, randomised, multicentre and parallel assignment. The study enrolled more than 426 patients across 93 study locations in the US, Australia, Belgium and Canada.
The primary outcome measure of the study includes finding time to disease progression or death in five years. The secondary outcome measures include finding adverse events in two years and the number of patients alive or dead in five years. The results of the study are expected to come by May 2013.
Marketing commentary for Calgene's drug
Celgene Corporation holds the marketing rights of pomalyst in the US. The drug faces competition in the market from Kyprolis (carfilzomib), a similar drug marketed by Onyx Pharmaceuticals and approved by the FDA for the same indication.
