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Phase III Trial Evaluates Zevalin (Ibritumomab Tiuxetan) for Aggressive Lymphoma
Spectrum Pharmaceuticals, Inc., based in Henderson, Nev., announced on September 19 that the company has initiated patient enrollment in the randomized phase III Zevalin Evaluation as Sequential Therapy (ZEST) trial of Zevalin (ibritumomab tiuxetan) injection for intravenous (IV) use for first-line consolidation in patients with diffuse large B-cell lymphoma (DLBCL) who have achieved remission following R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
The ZEST trial will assess overall survival (OS) and progression-free survival (PFS) with Zevalin in patients aged 60 years and older with newly diagnosed stage II to stage IV DLBCL with a complete response after the standard six courses of R-CHOP.
In a phase II study, treatment with Zevalin following R-CHOP resulted in a 5-year OS rate of 84% and 5-year PFS rate of 75% in 44 older patients (aged 62 to 86 years) with stage II to stage IV DLBCL. Overall survival was improved approximately 15% over that observed in similar-risk patients treated with R-CHOP alone, justifying confirmation of this finding in a larger randomized trial.
It estimated that more than 79,000 individuals will be diagnosed with lymphoma in 2012 and that more than 20,000 will die of the disease. Of the diagnosed patients, approximately 70,000 will have non-Hodgkin's lymphoma (NHL), resulting in approximately 18,940 deaths in the U.S. in 2012. DLBCL is the most common form of NHL, accounting for approximately 30% of cases.
Zevalin injection for IV use is currently indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL. Zevalin is also indicated for the treatment of patients with previously untreated follicular NHL who have achieved a partial or complete response to first-line chemotherapy.
Zevalin is a CD20-directed radiotherapeutic antibody. The Zevalin therapeutic regimen consists of two components: rituximab and yttrium-90 (Y-90) radiolabeled Zevalin for therapy. Zevalin builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
For more information, visit the Spectrum Pharmaceuticals Web site.