Wyeth Initiates INTORACT -- A New Clinical Trial to Examine TORISEL Plus Avastin for First-Line Treatment of Advanced Kidney Cancer

Collegeville, Pa. – Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced the initiation of the INTORACT (INvestigation of TORISEL and Avastin Combination Therapy) study, a worldwide randomized, open-label, phase 3b study comparing TORISEL® (temsirolimus) plus Avastin® (bevacizumab) versus Avastin plus interferon-alfa for first-line treatment of patients with advanced renal cell carcinoma (RCC). Wyeth Research is conducting the INTORACT study with the support and assistance of Roche and Genentech.

“Several therapies have been introduced in the past few years that have led to improvements in the way we treat advanced kidney cancer,” says Joseph S. Camardo, M.D., Senior Vice President, Global Medical Affairs, Wyeth Pharmaceuticals. “In the INTORACT study, we hope to learn more about whether combining TORISEL with other agents in the first-line setting may further improve outcomes for patients with this devastating disease.”

The primary end point of the INTORACT study is independently assessed progression-free survival (PFS) of patients in all risk groups. Secondary end points include safety, investigator-assessed PFS, independently assessed objective response rate (complete response plus partial response) and overall survival.

A treatment regimen combining the mTOR (mammalian target of rapamycin) inhibitor TORISEL with the vascular endothelial growth factor (VEGF) inhibitor Avastin was shown in a phase 1/2 trial of patients with stage IV renal cancer to have an acceptable safety profile and supported further investigation in a phase 3 study.

“We hope to learn whether a regimen that combines the angiogenesis inhibition of bevacizumab with the mTOR inhibition of temsirolimus may provide further evidence of clinical utility in advanced RCC,” says Brian Rini, M.D., of the Cleveland Clinic Taussig Cancer Institute in Cleveland, and co-principal investigator of INTORACT.

RCC will account for approximately 85 percent of the estimated 54,390 new cases of kidney cancer that will be diagnosed in the United States annually, and about 40 percent of these patients will have advanced disease at the time of diagnosis. Clear-cell RCC accounts for about 75 percent of all RCC cases.