In October 2010, Johnson & Johnson presented its second stage of Phase III trial analysis at the European Society for Medical Oncology congress. The agent under investigation was a novel and promising drug, abiraterone acetate, which demonstrated positive results in increasing survival in patients with advanced prostate cancer.
The COU-AA-301 randomized, placebo-controlled trial involved 1,195 patients with castrate-resistant prostate cancer (another name for metastatic advanced prostate cancer). The disease progressed after receiving chemotherapy based on Taxotere (docetaxel). One group of 797 men was treated with abiraterone acetate plus low-dose prednisone, and another group of 398 patients was treated with placebo plus prednisone/prednisolone. The abiraterone group demonstrated increased median survival to 14.8 months compared to 10.9 of the placebo group. Although 3.9 months seems not very much, but according to Lindsay Rosenwald and Johann de Bono, only four drugs in the history of prostate cancer had survival benefit; and abiraterone is likely to bring the change to the lives of patients with advanced prostate cancer.
36 percent of patients treated with abiraterone acetate had median survival and 35 percent had fatal outcome risks compared with patients in the placebo group. Furthermore, patients, who received abiraterone had significant improvement in secondary endpoints, including TTPP or time to PSA progression as well as RPFS or radiographic progression-free survival.
In September 2010, when the trial data demonstrated significant survival improvement, the analysts recommended that the patients treated with placebo in the Phase III study should be offered abiraterone acetate. In late 2010, Johnson & Johnson filed marketing applications for the approval of abiraterone acetate. If approved by FDA, the drug will be distributed in the U.S. and Europe by mid-2011; and then will follow in the rest of the world according to local regulations. Lindsay Rosenwald, MD, one of the lead investors in the biotechnology sector, noted that abiraterone acetate could become a very promising candidate that can bring difference to patients with advanced prostate cancer.
