New Phase III Clinical Trial with Anticancer Drug Zevalin

Schering AG and Biogen Idec announced October 4th the start of the ZEAL study (ZEVALIN as consolidation therapy in Aggressive Lymphoma). Approximately 400 patients with Non-Hodgkin’s Lymphoma (NHL) will be enrolled in this Phase III, international multi-center clinical trial.

The study will evaluate the effectiveness and safety of Zevalin in patients with Diffuse Large-B-cell Lymphoma (DLBCL) – the most common type of aggressive Non-Hodgkin’s Lymphoma. Patients are eligible if they are in complete remission (CR) or unconfirmed complete remission (CRu) after first-line CHOP-rituximab (CHOP-R) therapy. One group of patients will receive Zevalin, the other group will be observed only without treatment. The trial is being conducted in 46 U.S. and 57 European, Asian and Canadian centers.

The trial is an open-label, prospective, two-armed, randomized group-sequential study. The duration of treatment will be two treatment days one week apart followed by a 12-week period with intense observation. The total duration of the trial is anticipated to be about 4 years. Entry criteria include patients older than 60 years of age with DLBCL who are in complete remission (CR or CRu) after six or eight cycles of first-line treatment with CHOP chemotherapy in combination with rituximab (CHOP-R).

The primary endpoint for the trial is overall survival (OS), with disease-free survival and health-related quality of life as secondary endpoints. Once the final data from the trial are completed and analyzed, Schering AG and Biogen Idec expect to file an application seeking to expand the product’s current label to include first-line therapy for patients with aggressive DLBCL.

"Diffuse Large-B-cell Lymphoma is a disease that progresses very fast. It’s important that patients have options that provide the best efficacy available, especially in this indication where a complete cure is the goal. Therefore, Schering, along with our partner Biogen Idec, is confident that with Zevalin we can bring a significant improvement to the treatment of this disease," said Peter Zundorf, Head of Schering’s Oncology Global Business Unit.

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