Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today results from a Phase 3 trial which demonstrated cabazitaxel, an investigational compound, plus prednisone/prednisolone significantly improved overall survival and progression-free survival in patients with metastatic (advanced) hormone-refractory prostate cancer whose disease progressed following treatment with docetaxel-based chemotherapy. The TROPIC trial compared the combination of cabazitaxel plus prednisone/prednisolone to the active agent mitoxantrone plus prednisone/prednisolone.
For many patients with metastatic hormone-refractory prostate cancer, their disease continues to progress despite prior chemotherapy. Currently, there are no approved therapies to treat these patients.
"These are significant results in the development of this investigational drug," said Dr. Oliver Sartor, North American principal investigator, Piltz Professor for Cancer Research at Tulane Medical School, New Orleans. "Improved overall survival was demonstrated in this trial – and 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."
TROPIC was designed to assess patients with metastatic hormone-refractory prostate cancer whose disease had progressed following treatment with docetaxel-based chemotherapy. Results showed that the combination of cabazitaxel and prednisone/prednisolone significantly reduced the risk of death by 30%>