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RAD001 Combined with Sandostatin LAR(R) Depot and as Monotherapy Controls Growth of Rare Pancreatic Neuroendocrine Tumors
Date:9/13/2008

and overall survival, changes in plasma chromogranin A and pharmacokinetics in both groups.

Monotherapy treatment group results

Clinical benefit (overall response rate plus stable disease rate) was seen in 77% of patients. The overall response rate for patients who received RAD001 alone was 8% (CI= 3.6-14.3). All confirmed responses were partial responses; there were no complete responses. In addition, 69% of patients experienced stable disease, 14% of patients experienced progressive disease and 10% of patients had an unknown response. Responses were maintained for a median of 10.6 months (8.3-N/A). Further, the results demonstrate PFS of 9.3 months. Median overall survival had not been reached at the time of data evaluation.

The most frequent adverse events in patients taking RAD001 alone were stomatitis (44%), rash (40%), diarrhea (37%), fatigue (29%), nausea (26%), vomiting (17%), asthenia (16%), anemia (12%) and weight decrease (11%).

Combination treatment group results

Clinical benefit (overall response rate plus stable disease rate) was seen in 82% of patients. The overall response rate for patients who received RAD001 in combination with Sandostatin LAR Depot was 4% (CI= 0.5-15.1). All confirmed responses were partial responses; there were no complete responses. The data show that 78% of patients experienced stable disease, 2% of patients experienced progressive disease and 16% of patients had an unknown response. Further, the results demonstrate PFS of 12.9 months. Median overall survival had not been reached at the time of data evaluation.

The most frequent adverse events in patients taking RAD001 with Sandostatin LAR Depot were stomatitis (49%), rash (40%), diarrhea (29%), fatigue (33%), nausea (33%), vomiting (13%), asthenia (11%), anemia (18%) and weight decrease (16%).

About NET

The term "neuroendocrine tumor" or "NET," as defined by the World Health Organization, refers to a diverse mixture of t
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SOURCE Novartis Pharmaceuticals Corporation
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