Spectrum Pharmaceuticals, Inc. (NasdaqGS: 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 meeting's 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 aloneCANCER", 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”
"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,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."
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