Abiraterone acetate extends median survival by 3.9 months in mCRPC
Posted Oct 11 2010 12:00am
The results of a randomized, double-blind, placebo-controlled, multi-center, Phase III clinical trial comparing abiraterone actetate + prednisone to a placebo + prednisone in men with metastatic castration-resistant prostate cancer (mCRPC) were presented today at the annual meeting of the European Society for Medical Oncology in Milan, Italy.
This first Phase III trial of abiraterone acetate , initiated in early 2008, enrolled 1,195 men with mCRPC who had progressive prostate cancer following one or two courses of chemotherapy, including one course of docetaxel-based chemotherapy.
Patients could not have received prior treatment with ketoconazole, abiraterone acetate, any other drug that acts as a CYP17 inhibitor, or any other investigational drug that targets the androgen receptor. They also had to have an ECOG performance status of 0 to 2. Eligible patients were enrolled at 147 clinical sites in Australia, Europe, the USA, and Canada.
The key data presented by Dr. de Bono on behalf of the investigators are as follows:
Patients were randomized in a 2:1 fashion, with 797 patients randomized to abiraterone acetate + prednisone and 398 patients randomized to a placebo + prednisone.
Patients treated with abiraterone + prednisone had a 35 percent reduction in their risk of death (hazard ratio [HR] = 0.65) compared to those receiving a placebo + prednisone.
Median survival of patients receiving abiraterone was 14.8 months compared to 10.9 months for those receiving the placebo.
Time to disease progression was 10.2 months among those on abiraterone and 6.6 months for the placebo patients.
The two most evident adverse effects of abiraterone acetate + prednisone were fluid retention and hypokalemia (elevated potassium levels).
Most adverse events of abiraterone acetate + prednisone appear to be manageable and do not include any of the classic side effects of chemotherapy.
Marketing applications for abiraterone in the U.S. and Europe are scheduled to be filed by the end of this year. Additional details about the results of the trial are available in a media release from subsidiaries of Johnson & Johnson .
Abiraterone acetate becomes the second drug this year to demonstrate a clear median survival benefit in men with mCRPC and with progressive disease after treatment with docetaxel-based chemotherapy, representing a practice-changing advance in the management of late-stage prostate cancer.
The results of a randomized, double-blind, placebo-controlled, multi-center, Phase III clinical trial comparing abiraterone actetate + prednisone to a placebo + prednisone in men with metastatic castration-resistant prostate cancer (mCRPC) were presented today at the annual meeting of the European Society for Medical Oncology in Milan, Italy.
This first Phase III trial of abiraterone acetate , initiated in early 2008, enrolled 1,195 men with mCRPC who had progressive prostate cancer following one or two courses of chemotherapy, including one course of docetaxel-based chemotherapy.
Patients could not have received prior treatment with ketoconazole, abiraterone acetate, any other drug that acts as a CYP17 inhibitor, or any other investigational drug that targets the androgen receptor. They also had to have an ECOG performance status of 0 to 2. Eligible patients were enrolled at 147 clinical sites in Australia, Europe, the USA, and Canada.
The key data presented by Dr. de Bono on behalf of the investigators are as follows:
Marketing applications for abiraterone in the U.S. and Europe are scheduled to be filed by the end of this year. Additional details about the results of the trial are available in a media release from subsidiaries of Johnson & Johnson .
Abiraterone acetate becomes the second drug this year to demonstrate a clear median survival benefit in men with mCRPC and with progressive disease after treatment with docetaxel-based chemotherapy, representing a practice-changing advance in the management of late-stage prostate cancer.