The 755-subject trial showed median overall survival of 15,1 months for patients treated with cabazitaxel in combination with prednisone, a steroid, compared to 12,7 months for patients treated with a combination of the prostate cancer drug mitoxantrone and prednisone, the company said in a statement.
Men involved in the trial had metastatic hormone-refractory prostate cancer that had worsened despite treatment with docetaxel-based chemotherapy.
Sanofi said the cabazitaxel regimen “significantly reduced the risk of death by 30%.” The most serious side effects included low levels of white blood cells and infections. Nearly 5% of cabazitaxel patients died due to adverse events, compared to 2% in the mitoxantrone arm.
“These are the first data to show a statistical improvement in overall survival in patients with this difficult-to-treat and aggressive form of prostate cancer,” Dr. Oliver Sartor, the trial’s lead investigator and a cancer research professor at Tulane Medical School in New Orleans said in a statement.
Sanofi said the results will be presented on Friday at a San Francisco meeting sponsored by the American Society for Clinical Oncology.
Cabazitaxel recently received fast track designation from the US Food and Drug Administration — a process designed to expedite the review of drugs being developed for serious diseases with the potential to address an unmet medical need.