Spectrum Begins Phase III ZEST Study

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Spectrum Pharmaceuticals, Inc. (SPPI) recently initiated the phase III ZEST (Zevalin Evaluation as Sequential Therapy) study of Zevalin. The study aims to evaluate the product in patients suffering from diffuse large B-cell lymphoma (:DLBCL) and who are in remission after R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone).

The study aims to compare the Zevalin therapeutic regimen to observation in patients with newly diagnosed (stage II-IV) DLBCL.

The primary objective of the study is to assess the overall survival (:OS) in patients (60 years and above). The study will also evaluate the two-year OS rate and progression-free survival (PFS) in these patients. Spectrum Pharma is conducting the ZEST study after several phase II clinical trials which helped to advance Zevalin into a registrational-quality study in aggressive lymphoma.

DLBCL is the commonest form of aggressive non-Hodgkin's lymphoma. As per the SEER data base, around 70,000 people will be diagnosed with non-Hodgkin's lymphomas in the US, of which around 18,940 deaths are expected in the US.

Notably, in April this year, Spectrum Pharma entered into a licensing agreement with Bayer AG (BAYRY) to market Zevalin outside the US. As per the agreement Spectrum Pharma has the marketing rights, patents and access to all the existing inventory of Zevalin from Bayer. Zevalin is currently approved over 40 other countries, including countries in Europe, Latin America and Asia.

Zevalin (rituximab and Yttrium-90), a CD20-directed radiotherapeutic antibody, is a part of Zevalin therapeutic regimen. Zevalin is already indicated for the treatment of patients suffering from relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (:NHL) and for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy.

Our Recommendation

We have an Underperform recommendation on Spectrum Pharma. The company carries a Zacks #3 Rank (Hold) in the short run.

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