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news.Sanofi-aventis has reported results from a Phase 3 trial which demonstrated Cabazitaxel, an investigational compound, plus prednisone/prednisolone 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.
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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.
Sanofi-aventis said that the Tropic trial was designed to assess patients with metastatic hormone-refractory prostate cancer whose disease had progressed following treatment with docetaxel-based chemotherapy.
The trial results showed that the combination of Cabazitaxel and prednisone/prednisolone reduced the risk of death by 30% with a clinically meaningful improvement in the median overall survival of 15.1 months in the Cabazitaxel combination arm vs 12.7 months in the mitoxantrone combination arm.
In the trial the patients who received the combination treatment with Cabazitaxel also experienced an increase in median progression-free survival.
Sanofi-aventis said that the results are expected to be presented by Sartor in San Francisco, CA on March 5 at the 2010 Genitourinary Cancers Symposium sponsored by the American Society for Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO).
Oliver Sartor, principal investigator of North America, said: “These are significant results in the development of this investigational drug. 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.”
Debasish Roychowdhury, senior vice president of global oncology at Sanofi-aventis, said: “These are compelling results which we are looking forward to sharing with the health care and oncology community. Providing new options and hope for patients with serious diseases, such as metastatic hormone-refractory prostate cancer, is what drives our ongoing commitment to researching and exploring novel anti-cancer compounds and to bringing these medicines to patients.”