A independent data monitoring committee has recommended that advanced prostate cancer patients in the placebo arm of a Phase III trial evaluating Ortho Biotech Oncology R&D's abiraterone acetate be offered treatment with the promising candidate following the unblinding of study data.
Study COU-AA-301 included 1,195 patients who were randomized to receive abiraterone acetate plus prednisone or placebo plus prednisone. The committee's 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. The company is evaluating the filing strategy for abiraterone acetate based on the committee's recommendation to unblind this study.
Scientists at Cancer Research UK and the Institute for Cancer Research at London's Royal Marsden Hospital have been studying the drug closely. Two years ago, researchers said that the therapy was responsible for shrinking tumors in 80 percent of the men taking it. Johnson & Johnson acquired the drug when it bought out Cougar Biotechnology last year. And Cougar had licensed the drug from BTG.
"Clear success leads us to think it could be a $1 billion a year drug for prostate cancer (from $300m) and we upgrade the chance of success from 32 percent to 70 percent," says analyst Paul Cuddon at KBC Peel Hunt, as quoted by London South East.
And analysts don't seem to think an approval will affect the earnings of Provenge, given the different patient populations for each drug. "In our view, eventual approval of abiraterone in this treatment setting will not have [an] impact on Provenge market penetration in earlier-stage disease for which Provenge is indicated," George Farmer of Canaccord Genuity says in a note.
Abiraterone could potentially compete immediately with Sanofi-Aventis' new drug cabazitaxel, which also prolonged survival in prostate cancer patients previously treated with chemotherapy, according to TheStreet's Adam Feuerstein. He adds that Medivation and partner Astellas are developing MDV3100, a prostate cancer drug that works in a very similar way to abiraterone. Phase III studies are under way.