Temsirolimus Plus Bevacizumab to Be Studied in Advanced Kidney Cancer

Wyeth Pharmaceuticals recently announced the initiation of the INTORACT (INvestigation of TORisel and Avastin Combination Therapy) study, a worldwide randomized, open-label, phase IIIB study comparing temsirolimus (Torisel) plus bevacizumab (Avastin) vs bevacizumab 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, md, 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."

Study Endpoints

The primary endpoint 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 mammalian target of rapamycin (mTOR) inhibitor temsirolimus with the vascular endothelial growth factor (VEGF) inhibitor bevacizumab was shown in a phase I/II trial of patients with stage IV renal cancer to have an acceptable safety profile and supported further investigation in a phase III 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," said Brian Rini, md, of the Cleveland Clinic Taussig Cancer Institute in Cleveland, and co–principal investigator of INTORACT.