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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

President, Global Head, Novartis Oncology Development. "These latest data show an antitumor effect in lymphoma that support the rationale for a Phase III study of Afinitor to prevent relapse in patients with diffuse large B-cell lymphoma, where there is a significant unmet medical need."

Novartis has initiated PILLAR-2 (PIvotaL Lymphoma triAls of RAD001), a Phase III trial investigating adjuvant treatment with everolimus (RAD001) in poor-risk patients with DLBCL who achieved complete remission with first-line rituximab combined with chemotherapy. This worldwide study will evaluate the potential of everolimus to extend disease-free survival in patients with DLBCL. The longer a patient with DLBCL is in remission the higher their likelihood to remain disease-free. There is no approved therapy for the approximately 50% of patients who will relapse after achieving a complete response on initial treatment, demonstrating an important unmet need(6).

EHA study details

The proof-of-concept, open-label, single-arm, multicenter Phase II study was designed to assess the efficacy and safety of everolimus in patients with relapsed/refractory aggressive or indolent NHL or Hodgkin's disease whose disease progressed despite prior treatment. Patients had received a median of four prior therapies (between one and 15 therapies). The study included patients with T-cell non-Hodgkin's lymphoma, Hodgkin's disease, follicular lymphoma, mantle cell lymphoma, DLBCL and small lymphocytic lymphoma; all of whom had experienced disease progression despite prior treatment. The primary endpoint of the study is to assess ORR. Secondary endpoints include assessment of progression-free survival (PFS), overall survival, time to disease progression and the safety profile of Afinitor(1).

In the trial, everolimus showed anticancer activity across multiple types of lymphoma, including T-cell non
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SOURCE Novartis
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