Positive results of Phase III study of Zytiga (Janssen Biotech) in metastatic Prostate Cancer

Results of a Phase III trial of Zytiga (abiraterone acetate), from Janssen Biotech, confirm it offers a significant survival benefit to patients with castration-resistant metastatic Prostate Cancer. The study, the first Phase III trial to show a significant survival benefit for this kind of drug, involved 1195 patients in thirteen countries, and compared the effects of prescribing Zytiga and the steroid prednisone, which combats some of the side effects of Prostate Cancer treatment, with a placebo plus predisnone.

The trial participants had all undergone at least one earlier round of chemotherapy with another drug, docetaxel, which had not halted the progression of their cancer. The researchers found that treatment with Zytiga resulted in an average survival time of 15.8 months, compared to 11.2 months for those given a placebo. For patients with metastatic Prostate Cancer, the average overall survival time for patients who have undergone chemotherapy is consistently less than two years, so the increased survival time offered by Zytiga could result in substantially improved prospects for patients whose cancer continues to progress after initial treatment with docetaxel. The trial also confirmed that abiraterone acetate appears to have a good safety profile; although some adverse events were recorded in patients given the drug, these were generally reversible, and didn't prevent continuation of the treatment.

The study, led by Dr Karim Fizazi of the Institut Gustave Roussy in France, was published in The Lancet Oncology. See: "Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study." By Karim Fizazi et al. The Lancet Oncology, September 18, 2012 http://dx.doi.org/10.1016/S1470-2045(12)70379-0