Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Oct 4 2010

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that data from the Phase III TROPIC study, which was the basis for the June 2010 U.S. Food and Drug Administration (FDA) approval of Jevtana® (cabazitaxel) Injection, was published in the October 2, 2010 print edition of The Lancet in an article titled "Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial." The data demonstrated that Jevtana in combination with prednisone reduced the risk of death by 30% in men with metastatic castration-resistant prostate cancer (also known as metastatic hormone refractory prostate cancer, or mHRPC) whose disease progressed following treatment with a docetaxel-containing treatment regimen.

"Jevtana is the first approved therapy to fill a critical gap among patients with the most advanced stage of prostate cancer and is the first therapeutic option for these patients shown to prolong survival,"  said Oliver Sartor, M.D., Piltz Professor for Cancer Research at Tulane Medical School, New Orleans, and North American principal investigator for the pivotal TROPIC trial.

"Sanofi-aventis Oncology is tackling cancer on all fronts to provide new solutions that make a difference in patients' lives," said Debasish Roychowdhury, M.D., Senior Vice President, Head of Global Oncology, sanofi-aventis. "The publication of this pivotal trial in The Lancet underscores the importance of the study, which is the first to demonstrate an overall survival advantage in patients with metastatic hormone refractory prostate cancer whose disease has progressed following treatment with a docetaxel-containing treatment regimen."

Results of the TROPIC study showed that the combination of Jevtana and prednisone significantly reduced the risk of death by 30%>

In the TROPIC study, the most common (greater than or equal to 10%) adverse reactions (grade 1-4) were neutropenia, anemia, leukopenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysguesia, cough, arthralgia, and alopecia.

The most common (greater than or equal to 5%) grade 3-4 adverse reactions in patients who received Jevtana were neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea, fatigue, and asthenia. The most common adverse reactions leading to treatment discontinuation in the Jevtana group were neutropenia and renal failure. Treatment discontinuations due to adverse drug reactions occurred in 18% of patients who received Jevtana and 8% of patients who received mitoxantrone. Deaths due to causes other than disease progression within 30 days of last study drug dose were reported in 18 (5%) Jevtana patients and 3 (less than 1%) mitoxantrone-treated patients. The most common fatal adverse reactions in Jevtana patients were infections>