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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

Select ASH Presentation Summaries

Following are summaries of key ZEVALIN, FOLOTYN and belinostat presentations at ASH:

Abstract # 1978 - Autologous Stem Cell Transplantation with Yttriumm-90-Ibritumomab Tiuxetan (Zevalin) Plus BEAM Conditioning in Patients with Refractory Non-Hodgkin Diffuse Large B-Cell Lymphoma: Results of a Prospective, Multicenter, Phase II Clinical Trial

A multi-center, investigator-sponsored Phase 2 study in Spain evaluated Zevalin and BEAM chemotherapy (carmustine, etoposide, cytarabine, and melphalan) prior to ASCT in patients with refractory DLBCL. Patients had received a median of 3 (range 2-6) therapies prior to transplantation. Overall response 100 days after transplantation was 70% with 60% complete responses. After a median follow-up of 22.7 months for alive patients 2-year overall and progression-free survival was 65% and 63%, respectively. The authors concluded that “ASCT with conditioning including Zevalin radioimmunotherapy plus BEAM is safe, and results in a very high response rate with promising survival in this very poor prognosis group of refractory DLBCL patients.” Prof. Arnon Nagler, Tel Aviv University Sackler School of Medicine, who did not participate in the study, commented: “Results of this and other Phase 2 studies affirm the wisdom to confirm these results, quickly and definitively, in the recently commenced randomized, international ‘SPINOZA’ study.”

Abstract # 2687 - A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients with Previously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's Lymphoma: an Eastern Cooperative Oncology Group Study (E3402)

Clinical centers within the Eastern Cooperative Oncology Group (ECOG) conducted a Phase 2 study of ZEVALIN for first-line consolidation in patients with early, Stage I - II DLBCL who previously achieved a partial response (PR) or functional complete response (CR or CRu/PR and PET negative) following R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Clinical findings showed that, for the patients who completed ZEVALIN consolidation, 87% were in CR/CRu and 89% were in functional CR. At 4 years, 88% of patients remained progression free and 98% were alive.

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