According to a Phase 3 clinical trial presented at the 35th meeting of the European Society for Medical Oncology in Milan, after being treated with abiraterone acetate, a novel drug by Johnson & Johnson, patients with metastatic prostate cancer live about 4 months longer compared to the patients with the same disease and treated with a placebo.
J&J revealed its trial results last month and demonstrated the positive effect of abiraterone. It also said that it would seek the approval of the drug by FDA by the end of the year.
The research and design of abiraterone acetate was initially funded by Lindsay Rosenwald, MD, who saw a great prospect in the drug candidate. Along with his researchers and analysts, Dr. Rosenwald made investments in the promising prostate cancer drug and this was the first step towards its clinical trials and further approval by FDA. Being one of the most productive businessmen and financial investors in the biotechnology sector, Lindsay Rosenwald supports the development of innovative promising drugs and nanotechnologies expanding the horizons of the modern medicine. By investing in the original research and trials by Cougar Biotechnology, which was acquired by J&J in 2009, Lindsay Rosenwald promoted indirectlythe development of abiraterone giving more chances to advanced prostate cancer patients.
The Phase 3 trial included 1,195 patients with advanced prostate cancer, where 398 patients received abiraterone plus prednisone treatment, while 797 patients were treated with a placebo plus prednisone. All the men, who took part in the trial, were diagnosed with metastatic castrate-resistant prostate cancer, whose condition wasn’t improved after hormonal therapy or docexatel-based chemotherapy.
About 35% of patients, who took abiraterone acetate, had improved survival rate. They lived median 14.8 months compared to those treated with a placebo plus prednisone, who lived median 10.9 months. The difference in survival shows that abiraterone significantly prolongs life.
The principle of the drug’s work lies in its ability to reduce the production of male hormones, including testosterone, which fuels the tumor cells and promotes their growth in different parts of the body. The initial stages of prostate cancer are usually treated with hormonal therapy aimed at inhibiting testosterone production and reducing the speed of tumor growth. However, most prostate cancers eventually become resistant to hormonal therapies and the tumor starts growing again.
J&J’s Phase 3 study demonstrated promising treatment results in patients with advanced metastatic prostate cancer unresponsive to hormonal therapy or docexatel-based chemotherapy. Such patients are called third-line patients and they have very poor survival and almost unsuccessful treatment. J&J also investigates cases with prostate cancer patients who have yet to undergo their chemotherapy. These are similar patients, who were tested in a study of another anti-cancer drug, Provenge by Dendreon.
Another abiraterone’s competitor is Jevtana owned by Sanofi-Aventis, which showed a median survival of 15 months compared to median 12.7 months for men receiving mitoxantrone, another chemotherapy regime.
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