Spectrum Pharmaceuticals Highlights Promising ZEVALIN®, FOLOTYN® and Belinostat Clinical Data Presented at the 54th …

HENDERSON, Nev.--(BUSINESS WIRE)--

Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced promising clinical data from investigator-sponsored studies of ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use, FOLOTYN (pralatrexate injection), and belinostat, Spectrums novel histone deacetylase (HDAC) inhibitor. As reported in poster presentations at the recent 54th Annual Meeting of the American Society of Hematology (ASH), studies of ZEVALIN showed promising results in diverse settings and potential indications, including first-line consolidation in patients with diffuse large B-cell lymphoma (DLBCL); treatment of elderly patients with non-Hodgkins lymphoma (NHL), and new drug combinations to treat follicular non-Hodgkins lymphoma (fNHL). In addition, preclinical in vivo research showed promising synergistic, anti-tumor activity of FOLOTYN, while a Phase 1 study demonstrated early evidence of activity of belinostat in combination therapy of patients, including those with relapsed or refractory acute leukemia.

This years ASH meeting was another important conference for Spectrum, both because of the number of presentations 12 for ZEVALIN, 3 for FOLOTYN and 4 for belinostat and the high quality of the data, said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. Members of the Eastern Cooperative Oncology Group, Sunnybrook Health Sciences Centre in Toronto and other key institutions around the world have reported findings that can help expand our understanding of ZEVALIN in specific patient groups, as well as in potential new applications and in combination with other therapies. Further, we are pleased with the reports from studies testing combination regimens that incorporate either FOLOTYN or belinostat, demonstrating research interest in potential synergies, especially for hard-to-treat diseases.

Spectrum's R&D program for ZEVALIN includes, among other initiatives, two Phase 3 studies that are sponsored or funded by the Company: the Phase 3 ZEST trial for first-line consolidation in patients with newly diagnosed DLBCL and the investigator-sponsored Phase 3 SPINOZA trial for patients with aggressive lymphoma who receive autologous stem cell transplantation (ASCT).

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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Spectrum Pharmaceuticals Highlights Promising ZEVALIN®, FOLOTYN® and Belinostat Clinical Data Presented at the 54th ...