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RAD001 More Than Doubles Time Without Tumor Growth After Failure of Standard Treatment in Patients With Advanced Kidney Cancer
Date:5/18/2008

ant difference in overall survival between the RAD001 and placebo groups (hazard ratio = 0.83 with 95% CI 0.50 to 1.37; p-value = 0.23). The study design allowed patients to be unblinded at the time of radiological disease progression; patients receiving placebo were allowed to cross over to receive RAD001. There was no significant difference in objective response rate between the RAD001 and placebo groups (1% vs. 0% of responders). However, in a central review among patients evaluable for best percentage change in target lesions (223 and 107 in RAD001 and placebo arms, respectively), tumor shrinkage was observed in 50% of patients receiving RAD001 during the double- blind portion of the study versus 8% of patients receiving placebo. Quality of life measurements taken throughout the study showed no significant difference between the RAD001 and placebo groups.

Safety findings in the study were consistent with those seen in prior Phase II studies. The most frequent adverse events in patients who took RAD001 included mouth sores (40%), feelings of weakness (37%), and rash (25%). There was a low incidence of grade 3 or 4 drug-related adverse events (greater than or equal to 1% of patients listed): mouth sores (3%), lung inflammation (3%), infection (3%), tiredness/feelings of weakness (4%), diarrhea (1%), mucosal inflammation (1%), and difficulty breathing (1%). The trial had a low rate of adverse drug reactions leading to discontinuation among patients who took RAD001 (6%).

About renal cell carcinoma (RCC)

In the United States, kidney cancer accounts for approximately 3% of all adult cancers. RCC, the most common type of kidney cancer, accounts for approximately 90% of malignant kidney tumors. In RCC, cancer cells develop in the lining of the kidney's tubes and grow into a tumor.

About RAD001

RAD001, an oral inhibitor of mTOR, is an investigational drug being studied in multiple tumor types. In cancer cells, RAD001 inhibits mTOR, a pr
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SOURCE Novartis Pharmaceuticals Corporation
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