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RAD001 Shows Potential to Reverse Resistance to Herceptin(R)* in Metastatic Breast Cancer Patients, Leading to Phase III Trial
Date:12/12/2008

y and through its influence on two of the most important pathways for breast cancer, the erbB receptor and the HER2 pathways.

"We are encouraged by the benefit RAD001 provided to advanced breast cancer patients in these early trials," said Alessandro Riva, MD, Executive Vice President & Global Head of Development, Novartis Oncology. "Novartis is committed to further evaluating the potential of RAD001 in combination with Herceptin as a new treatment regimen in breast cancer, as well as studying its role in treating other tumor types."

Novartis will initiate a worldwide Phase III clinical trial program to further evaluate the potential of RAD001 in combination with Herceptin and chemotherapy in patients with HER2-positive metastatic breast cancer. To learn more about the trial, please visit http://mail.breastcancerresearchstudy.com/, or speak to your doctor.

Study details: abstract #3119

An open-label, multicenter Phase I dose escalation trial evaluated daily RAD001 (5 mg, 10 mg) and weekly RAD001 (30 mg, 50 mg and 70 mg) regimens in combination with Taxol (80 mg/m2 IV over 60 min on days 1, 8 and 15 every 28 days) and Herceptin (2 mg/kg IV over 30 min) in heavily pretreated patients with HER2-positive metastatic breast cancer with prior resistance to Herceptin.

Across treatment arms, there was an overall disease control rate of 77% (complete response/ partial response/ stable disease greater than or equal to 16 weeks). Twenty-two heavily pretreated patients were evaluable for efficacy: treatment arms included five patients assigned to RAD001 5 mg daily, eight to RAD001 10 mg daily and nine to RAD001 30 mg weekly. Among the five patients evaluated in the 5 mg daily treatment arm, one patient had a complete response and four patients had partial responses. In the 10 mg daily treatment arm, one patient had
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SOURCE Novartis Pharmaceuticals Corporation
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