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"Several therapies have been introduced in the past few years that haveled to improvements in the way we treat advanced kidney cancer," says JosephS. Camardo, M.D., Senior Vice President, Global Medical Affairs, WyethPharmaceuticals. "In the INTORACT study, we hope to learn more about whethercombining TORISEL with other agents in the first-line setting may furtherimprove outcomes for patients with this devastating disease."
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The primary end point of the INTORACT study is independently assessedprogression-free survival (PFS) of patients in all risk groups. Secondary endpoints include safety, investigator-assessed PFS, independently assessedobjective response rate (complete response plus partial response) and overallsurvival.
A treatment regimen combining the mTOR (mammalian target of rapamycin)inhibitor TORISEL with the vascular endothelial growth factor (VEGF) inhibitorAvastin was shown in a phase 1/2 trial of patients with stage IV renal cancerto have an acceptable safety profile and supported further investigation in aphase 3 study.
"We hope to learn whether a regimen that combines the angiogenesisinhibition of bevacizumab with the mTOR inhibition of temsirolimus may providefurther evidence of clinical utility in advanced RCC," says Brian Rini, M.D.,of the Cleveland Clinic Taussig Cancer Institute in Cleveland, andco-principal investigator of INTORACT.
RCC will account for approximately 85 percent of the estimated 54,390 newcases 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 timeof diagnosis. Clear-cell RCC accounts for about 75 percent of all RCC cases.
Wyeth is conducting a number of studies examining TORISEL in varioussettings. Additional information about TORISEL studies is available athttp://www.clinicaltrials.gov.
About TORISEL
TORISEL is the only approved cancer therapy that specifically inhibits themTOR kinase, an important regulator of cell proliferation, cell growth andcell survival. Inhibition of mTOR in treated cancer cells blocked thetranslation of genes that regulate the cell cycle. In in vitro studies usingrenal cancer cell lines, TORISEL inhibited the activity of mTOR and resultedin reduced levels of certain cell growth factors involved in the developmentof new blood vessels, such as vascular endothelial growth factor.
TORISEL is approved for the treatment of advanced RCC in the UnitedStates, European Union and other markets, based on results of a phase 3clinical study that demonstrated that TORISEL improves overall survival forpatients with advanced RCC compared with interferon-alfa.
Important Safety Information
Hypersensitivity reactions manifested by symptoms, including, but notlimited to anaphylaxis, dyspnea, flushing, and chest pain have been observedwith TORISEL. Serum glucose, serum cholesterol, and triglycerides should betested before and during treatment with TORISEL. The use of TORISEL is likelyto result in hyperglycemia and hyperlipemia. This may result in the need foran increase in the dose of, or initiation of, insulin and/or oral hypoglycemicagent therapy and/or lipid-lowering agents, respectively.
The use of TORISEL may result in immunosuppression. Patients should becarefully observed for the occurrence of infection
