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Latest RAD001 Study Results Show Further Increase in Time Without Tumor Growth in Patients With Advanced Kidney Cancer
Date:9/15/2008

th due to any cause. Results of the study demonstrated a statistically significant improvement in PFS for RAD001 compared to placebo (hazard ratio = 0.33 with 95% CI 0.25 to 0.43; p-value < 0.001; median PFS 4.9 months vs. 1.9 months, respectively).

Secondary endpoints included comparison of overall survival, objective response rate, quality of life and safety. There was no significant difference in overall survival between the RAD001 and placebo groups (hazard ratio = 0.82 with 95% CI 0.57 to 1.17; p-value = 0.137). 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 (2% 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 vs. 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 (36%), rash (28%), feelings of weakness (23%) and tiredness (22%). There was a low incidence of grade 3 or 4 drug-related adverse events (greater than or equal to 1% of patients listed): infection (4%), mouth sores (3%), tiredness (3%), feelings of weakness (2%), lung inflammation (2%), diarrhea (2%), mucosal inflammation (1%), vomiting (1%) and difficulty breathing (2%). The trial had a low rate of adverse drug reactions leading to discontinuation among patients who took RAD001 (7%).

About RAD001

RAD001, an oral once-daily inhibitor of mTOR,
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SOURCE Novartis Pharmaceuticals Corporation
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