Sanofi-Aventis has presented promising late-stage data for its investigational prostate cancer treatment cabazitaxel.

Data from a Phase III trial, the full results from which will be presented at the Genitourinary Cancers Symposium in San Francisco on Friday, show that cabazitaxel significantly improved overall and progression-free survival in patients with metastatic hormone-refractory prostate cancer whose disease progressed following chemotherapy with the French drugmaker’s Taxotere (docetaxel).

The study, called TROPIC, involved 755 men with advanced prostate cancer who received either a combination of cabazitaxel and the steroid prednisone or the chemotherapy mitoxantrone and prednisone. The results revealed an overall median survival of 15.1 months in the cabazitaxel combo arm compared to 12.7 months and patients who received the combination treatment with cabazitaxel also experienced a
significant increase in median progression-free survival (2.8 months vs 1.4 months). Sanofi added that the cabazitaxel/prednisone combo significantly reduced the risk of death by 30%.

Oliver Sartor, co-lead investigator of Tulane University's School of Medicine, said that “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.” Sanofi’s oncology chief Debasish Roychowdhury added that “these are compelling results which we are looking forward to sharing with the health care and oncology community”.

No drugs are currently approved for second-line prostate cancer and cabazitaxel recently received fast-track designation from the US Food and Drug Administration. Sanofi noted that the rolling submission has already started, which allows for completed sections of a New Drug Application to be reviewed on an ongoing basis, and that in addition to prostate cancer, Sanofi is testing cabazitaxel in a number of other solid tumour studies.