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PoemStone

09/19/12 7:36 AM

#4885 RE: PoemStone #4884

SPPI. Spectrum Pharmaceuticals Initiates Phase 3 Study of ZEVALIN® in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL); Most Common Form of Aggressive Non-Hodgkin’s Lymphoma
• There is a substantial need for better treatments for DLBCL, which has low survival rates at five years; there are an estimated 20,000 new cases of DLBCL in the U.S. each year

• The ZEST study follows multiple Phase 2 clinical trials supporting advancement of ZEVALIN into a registrational-quality study in aggressive lymphoma; results from the largest of the studies, presented at the 2012 European Hematology Association annual meeting, showed an 84% 5-year overall survival (OS) rate and 75% 5-year progression-free survival (PFS) in older patients with stage II-IV DLBCL who received ZEVALIN following R-CHOP

• The ZEST (Zevalin Evaluation as Sequential Therapy) study will compare the ZEVALIN therapeutic regimen to observation in patients with newly diagnosed stage II, III, or IV DLBCL who are 60 years of age and older and who are in complete remission after first-line R-CHOP or R-CHOP like chemotherapy for their disease

• Primary endpoint is overall survival; secondary endpoints include 2-year OS rate and PFS

• Additional ZEVALIN clinical studies in aggressive lymphoma include the SPINOZA (Study with Preparatory INduction Of Zevalin in Aggressive lymphoma) trial, which to date has randomized 39 patients receiving autologous stem cell transplantation (ASCT) for relapsed DLBCL
http://finance.yahoo.com/news/spectrum-pharmaceuticals-initiates-phase-3-110000814.html