Phase III study opens for advanced RCC combination therapy

Wyeth Pharmaceuticals has announced initiation of the INTORACT (INvestigation of Torisel and Avastin Combination Therapy) study, a randomized, open-label phase III study comparing temsirolimus (Torisel) plus bevacizumab (Avastin) versus bevacizumab plus interferon-alfa for first-line treatment of patients with advanced renal cell carcinoma.

The primary endpoint of the study is independently assessed progression-free survival of patients in all risk groups. Secondary endpoints include safety, investigator-assessed progression-free survival, independently assessed objective response rate, and overall survival.

A treatment regimen combining temsirolimus with 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, co-principal investigator of INTORACT at Cleveland Clinic.