According to a media release from a division of Johnson & Johnson earlier today, an independent data monitoring committee has recommended that patients in the placebo arm of a Phase III trial of abiraterone acetate be offered treatment with abiraterone following unblinding of study data.
This recommendation comes in relation to the Phase III trial of abiraterone acetate in 1,195 patients with castration-resistant prostate cancer who had previously progressed after treatment with Taxotere, and who were randomized to receive treatment with abiraterone acetate + prednisone or placebo + prednisone. According to the media release, “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.” In other words, the recommendation implies that the patients treated with abiraterone had better survival than the patients treated with placebo.
We do not have any specific data to report at the present time. The initial trial results are scheduled for presentation at a medical meeting in Milan, Italy on October 8-12. However, this announcement does imply the possibility that Johnson & Johnson will be able to submit a New Drug Application for abiraterone acetate in treatment of patients with castration-resistant prostate cancer before the end of 2010, with the possibility for approval by mid-2011 or perhaps earlier (depending on the quality of the data).
Johnson & Johnson also announced that the company plans to initiate an early access, compassionate use program for abiraterone acetate later this year. Patients will need to meet pre-specified medical criteria. It is highly likely that eligibility criteria will be very similar to those specified for the original clinical trial itself, in which case eligible patients would have to have a rising PSA after treatment with at least two types of hormone therapy and after treatment with a docetaxel-based chemotherapy regimen. Participating treatment centers will be listed on the Clinical Trials.gov web site when they are ready to enroll patients. The goal is to have this program in operation at sites in the US some time in October 2010 and at sites outside the US in following months.