Ortho Biotech & Development, a unit of Cougar Biotechnology, Inc. has unblinded their Phase 3 study of abiraterone acetate plus prednisone. In the trial the abiraterone was used for the treatment of men with metastatic advanced prostate cancer has progressed following treatment with one or two chemotherapy regimens at least one of which contained docetaxel.
The COU-AA-301 study included 1,195 men who were randomized to receive abiraterone acetate plus prednisone or placebo plus prednisone.
The Independent Data Monitoring Committee’s (IDMC) recommendation to unblind the study was based on a pre-specified interim analysis, which demonstrated a statistically significant improvement in overall survival and an acceptable safety profile. Based on these results, the IDMC also recommended that men in the placebo arm be allowed to crossover and offered treatment with abiraterone acetate.
The other significant announcement was that the company announced they were initiating a program that will provide early access to abiraterone acetate to men who meet specified medical criteria.
When the program is started, the participating centers will be listed on www.clinicaltrials.gov. The company anticipates opening the program in the United States in October and in sites outside the United States soon after, contingent on local health authority and ethics committee approvals.
These trial results will be presented at the upcoming European Society for Medical Oncology congress, which will be held in Milan, October 8-12, 2010. They will also be submitted for publication in a peer-reviewed journal.
Abiraterone acetate is an investigational drug that many of us have been actively following and hoping to see approved by mid 2012. Its and efficacy will still need to be confirmed by the FDA. At this time the company is evaluating its FDA filing strategy based on the IDMC’s recommendation to unblind this study.
We can only hope that the FDA will be move quickly and grant ful and complete approval for the use with men with castrate resistant advanced prostate cancer.
Joel T. Nowak, M.A., M.S.W.