Johnson & Johnson has been boosted by the news that a late-stage trial of abiraterone has proved so successful in terms of survival that all participants in the trial will get access to the much-touted prostate cancer drug.
The healthcare giant says it has unblinded the Phase III study of abiraterone plus prednisone for the treatment of patients with metastatic advanced prostate cancer whose disease has progressed following treatment with one or two chemotherapies, at least one of which contained docetaxel.
J&J's decision follows the recommendation of the study's independent data monitoring committee' to unblind the study which included 1,195 patients randomised to receive abiraterone plus prednisone or placebo plus prednisone. A pre-specified interim analysis demonstrated a statistically significant improvement in overall survival and an acceptable safety profile and based on these results, the IDMC also recommended that patients in the placebo arm be offered treatment with abiraterone.
J&J got hold of the drug last year through its $970 million acquisition of Cougar Biotechnology which had licensed abiraterone from UK life sciences company BTG.
The full results will be presented at the European Society of Medical Oncologists meeting in Milan in October and J&J said it is "evaluating the filing strategy" based on unblinding the trial. An early access programme will begin in October in the USA and elsewhere "in the months following".