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Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial
Date:6/8/2009

- Afinitor significantly reduced tumor size by 50% or more in one out of three patients with refractory or relapsed lymphoma

- Phase III study underway to explore potential of Afinitor to prevent relapse in patients with the most common type of non-Hodgkin's lymphoma

EAST HANOVER, N.J., June 8 /PRNewswire/ -- New data show that Afinitor(R) (everolimus) tablets significantly shrunk tumors in 33% of patients with relapsed non-Hodgkin's lymphoma (NHL) and Hodgkin's disease(1). Based on results from this study and other early-stage research, Novartis has initiated a Phase III trial in the most common NHL, diffuse large B-cell lymphoma (DLBCL).

Non-Hodgkin's lymphoma and Hodgkin's disease, also known as Hodgkin's lymphoma, refer to a variety of cancers affecting the immune system, such as DLBCL, mantle cell lymphoma and follicular lymphoma(2). Up to 60% of patients with aggressive types of NHL, including DLBCL, may be cured with appropriate therapy(3). However, NHL patients have a high risk of relapse after initial therapy and no treatments are currently available to reduce this risk(4,5).

The Phase II open-label trial of 145 lymphoma patients was presented at the 14th annual European Hematology Association congress in Berlin, Germany. Results show that 33% of patients with relapsed NHL and Hodgkin's disease treated with everolimus experienced a 50% or greater reduction in tumor size. This 33% overall response rate (ORR) is defined as complete or partial tumor shrinkage (95% confidence interval: 26-41%). The median time to disease progression for all 145 patients was 4.3 months (95% CI; 3.6-5.9 months) and the median duration of response for the 48 responders was 6.8 months (95% CI; 5.4-11.0 months). Nineteen responders remained progression free at 6 months(1).

"We continue to see the potential of Afinitor in multiple types of cancer," said Alessandro Riva, MD, Executive Vice
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SOURCE Novartis
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