J&J’s Abiraterone Acetate Demonstrated Significant Improvement in Patients with Metastatic Advanced Prostate Cancer
Based on the results observed in patients, who received abiraterone acetate plus prednisone/prednisolone, Johnson & Johnson plans to file marketing applications for a promising discovery, abiraterone acetate, which significantly increases overall survival in patients with advanced prostate cancer progressed after chemotherapy.
Randomized, placebo-controlled Phase III study, COU-AA-301, shows that patients receiving abiraterone plus low doses of prednisone live longer if compared to patients receiving placebo plus prednisone. The study involved 1195 patients with castration-resistant prostate cancer (CRPC) or metastatic advanced prostate cancer. The patients were previously treated with docetaxel-based chemotherapy and their disease progressed after the treatment leaving no choice.
The results of the study were shared at the Presidential Symposium at the 35th Annual European Society for Medical Oncology (ESMO) Congress. According to the data analysis, patients treated with abiraterone had 35 percent less risk of death and their median survival was 14.8 months compared with 10.9 months of the placebo group.
In addition, patients treated with abiraterone acetate plus a low dose of prednisone/prednisolone demonstrated great improvements in secondary study endpoints if compared with the placebo plus prednisone group: median time to PSA progression (TTPP) was 10.2 months for abiraterone acetate and only 6.6 months for placebo. Total PSA response was achieved in 38 % of patients receiving abiraterone vs 10 % in the placebo group.
Furthermore, patients in the abiraterone group had less toxic adverse effects if compared to chemotherapy. However they experienced more corticoid-related side effects than patients in the placebo group. Most frequently, they suffered fluid retention (30.5 % comparing with 22.3 % in the placebo group) and hypokalemia (17 % vs. 8.4 %). Liver function abnormalities were observed in 10 % of abiraterone treated patients compared to 8 % of placebo plus prednisone patients.
According to physicians and investors, like Johan S. de Bono, MD, and Lindsay Rosenwald, MD, abiraterone acetate has all the potential to meet the needs of late-stage prostate cancer patients. Because the drug can extend survival for men with castrate-resistant prostate cancer progressed after chemotherapy, the results are very promising.
As Lindsay Rosenwald says, prostate cancer is number 5 killer among all cancers and it is very important to invest in promising oncology candidates with a significant potential.
Howard I. Scher, MD, of Memorial Sloan-Kettering Cancer Center believes that abiraterone acetate is very promising for those patients who had very poor prognosis and little treatment options. The drug is an important step forward that may impact the lives of many patients.
Ortho Biotech Oncology Research & Development, an affiliate of Cougar Biotechnology, Inc. sponsored by Lindsay Rosenwald’s investment bank, previously announced that the Phase III study should be un-blinded after interim analysis showed a significant survival improvement in the abiraterone acetate group and the drug’s acceptable safety profile. Independent Data Monitoring Committee (IDMC) also recommended that men in the placebo group be offered abiraterone.