Ortho Biotech Oncology Research & Development's pre-specified interim analysis of a randomised, placebo-controlled Phase 3 study, COU-AA-301, demonstrated that patients treated with the investigational agent Abiraterone acetate plus low dose prednisone/prednisolone showed an improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo.
COU-AA-301 study was conducted in patients with metastatic advanced prostate cancer (also referred to as castration-resistant prostate cancer, or CRPC) previously treated with one or two chemotherapy regimens, at least one of which contained docetaxel.
Reportedly, treatment with Abiraterone acetate resulted in a 35% reduction in the risk of death and a 36% increase in median survival compared with placebo.
Patients who received Abiraterone acetate and low dose prednisone/prednisolone also showed improvements in secondary study endpoints when compared to the prednisone/prednisolone plus placebo group.
One of the COU-AA-301 investigators Johann de Bono said that they were pleased with the definitive results of the study, which showed that Abiraterone acetate may extend survival for men with metastatic advanced prostate cancer that progressed after treatment with docetaxel.
Janssen-Ortho will have the marketing rights to Abiraterone acetate in Canada where the drug has not received marketing authorisation and is for investigational use only.
Based on the positive results of the Phase 3 study, Janssen is planning for marketing applications with regulatory authorities worldwide.
Ortho Biotech Oncology Research & Development, a unit of Cougar Biotechnology, partners with affiliated units and companies in the Janssen Pharmaceutical Companies of Johnson & Johnson such as Centocor Ortho Biotech and Janssen in the research and development of oncology and supportive care treatments.