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Spectrum Pharmaceuticals Highlights Promising ZEVALIN®, FOLOTYN® And Belinostat Clinical Data Presented At The 54th Annual Meeting Of The American Society Of Hematology

Abstract # 2742 - RIT with 90Y Ibritumomab Tiuxetan in Patients with Non-Hodgkin Lymphoma Over 65 Years

An investigator-sponsored Phase 2 study in patients over 65 years of age, mean age 72.8 years (range 65-87), with CD20+ NHL reported positive results, demonstrating that consolidation therapy with ZEVALIN early in the course of treatment resulted in a mean progression free survival (PFS) of 54.2 months . According to the authors of the clinical trial abstract, ZEVALIN “offers good and maintained response rate with lower toxicity in this fragile population.” Further, overall survival (OS) in this population was found to be not inferior to rates that have been observed in younger NHL patients.

Abstract # 3657 - Short Course of Bendamustine and Rituximab Followed by 90Y-Ibritumomab Tiuxetan in Patients with Chemotherapy-Naïve Follicular Lymphoma: Early Results of "Fol-Brite"

Results of an investigator-sponsored Phase 2 study in patients with grade 1-2 or 3a fNHL showed that of the patients who completed bendamustine and rituximab conditioning followed by consolidation treatment with ZEVALIN by the time of a pre-planned interim analysis, 85.7% had achieved a complete response (CR) rate. This CR rate, being announced for the first time in a major medical conference, well surpassed the level required to continue the study of this sequential therapeutic regimen, which the abstract authors noted was “a promising option for the treatment of follicular lymphoma.”

Abstract # 3681 - Sustained Immune Competency and Long Term Molecular Remissions in FL Patients with FLIPI Risk Factors >1, Treated Front Line with R-CHOP Followed by Consolidative 90 Υ-Radioimmunotherapy and Maintenance Rituximab

Clinicians at Sunnybrook Health Sciences Centre, Toronto, presented updated findings from a Phase 2 study in patients with high-risk (FLIPI 2-5), advanced-stage fNHL who received “triple therapy” of R-CHOP induction chemotherapy, followed by ZEVALIN consolidation and 2 years rituximab maintenance. Of those patients with PCR detectable t(14;18) translocations who were evaluated before and after Zevalin, 94% became PCR negative in blood following ZEVALIN consolidation, indicating Complete Response at the molecular level. For patients with FLIPI=2, 93% remained progression free over a median follow-up period of 32 months, a rate similar to or more favorable than previous reports.

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