Spectrum Pharmaceuticals Announces Outstanding ZEVALIN® Clinical Data In Aggressive Relapsed/Refractory Lymphoma …

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

Spectrum Pharmaceuticals, Inc. (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced new clinical data presented in an oral presentation for ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use at the 17th Congress of the European Hematology Association (EHA). In one of only four abstracts accepted for oral presentation in the meetings clinical transplantation session (Abstract # 1118), Dr. Avichai Shimoni (Chaim Sheba Medical Center, Tel Hashomer, Israel) presented an update with longer follow-up time from a multi-center, prospective randomized study, for which he reported that ZEVALIN administered in combination with BCNU, etoposide, cytarabine (Ara-C), melphalan (BEAM) therapy Z-BEAM resulted in a 91% two-year overall survival (OS) rate in patients with refractory/relapsed aggressive lymphoma, versus a 62% OS rate in patients administered BEAM alone (p=0.03). Based on these findings, which were updated from results published January 2012 in the journal "CANCER", the Journal of the American Cancer Society, Spectrum's development program for ZEVALIN has been expanded to include support for a larger, randomized international study using the Z-BEAM regimen as a preparative regimen for patients with lymphoma who receive autologous stem cell transplantation (ASCT). This international study, known as the SPINOZA trial (Study with Preparatory Induction Of ZEVALIN in Aggressive Lymphoma), recently started accrual.

Patients with relapsed/refractory aggressive lymphomas have an abysmal prognosis and greatly reduced overall survival compared to those with indolent cancer. While stem cell transplantation has become the standard of care for appropriate patients in this setting, unfortunately there is no standard preparatory regimen prior to ASCT, stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. We believe that these results, should they be confirmed in the broader clinical program currently underway, will be key in optimizing the preparative regimen by incorporating ZEVALIN and thus improving outcomes for these patients.

In the Z-BEAM study, 43 patients with CD20-positive, aggressive lymphoma (34 with diffuse large B-cell lymphoma (DLBCL); 9 with transformed follicular lymphoma) were randomized to a treatment arm (Z-BEAM, N=22) or control arm (BEAM alone, N=21). Patient and disease characteristics were well matched between the groups. Median follow-up was 39 months, and at the time of analysis, all patients had reached the primary endpoint of 2-year overall survival. Results for overall survival were improved for patients receiving Z-BEAM compared to BEAM in 34 patients with DLBCL (2-year OS 94% Z-BEAM versus 56% BEAM, p=0.01). These and other findings from the study led the study researchers to conclude that standard-dose ZEVALIN combined with BEAM high-dose chemotherapy is safe and possibly more effective than BEAM alone as conditioning regimen for ASCT in the era of rituximab-containing chemotherapy regimens.

About Non-Hodgkin's Lymphoma

According to the National Cancer Institute (www.cancer.gov), there are expected to be 70,130 new cases of non-Hodgkin's lymphoma diagnosed and approximately 18,940 deaths in the United States in 2012. Non-Hodgkin's lymphoma is defined as any of a large group of cancers of lymphocytes (white blood cells). Non-Hodgkin's lymphomas can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. There are many different types of non-Hodgkin's lymphoma. These types can be divided into aggressive (fast-growing) and indolent or low grade (slow-growing) types, and they can be formed from either B-cells or T-cells. Prognosis and treatment depend on the stage and type of disease.

About ZEVALIN and the ZEVALIN Therapeutic Regimen

ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin's lymphoma who achieve a partial or complete response to first-line chemotherapy.

ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.

Important ZEVALIN Safety Information

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Spectrum Pharmaceuticals Announces Outstanding ZEVALIN® Clinical Data In Aggressive Relapsed/Refractory Lymphoma ...