The phase 3 trial upon which abiraterone acetate approval was based is now available in The New England Journal of Medicine. In this study, the COU-AA-301 Investigators showed that at a median follow-up of 12.8 months, overall survival was prolonged in patients who received 1000 mg of abiraterone acetate in combination with 5 mg of prednisone twice daily compared with placebo (14.8 months vs 10.9 months; hazard ratio, 0.65; 95% CI, 0.54-0.77; P <.001). All patients had received docetaxel previously. Progression-free survival and prostate-specific antigen response rate were also improved in the abiraterone group.
Complete study results can be viewed at http://www.nejm.org/doi/full/10.1056/NEJMoa1014618#t=article.