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 initiation of patient enrollment in the Company’s randomized Phase 3 ZEST (
herapy) trial of ZEVALIN
(ibritumomab tiuxetan) Injection for intravenous use for first-line consolidation in patients with diffuse large B-cell lymphoma (DLBCL) who achieved remission following R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). The study will assess overall survival (OS) and progression-free survival (PFS) in patients 60 years and older. Patients will consist of newly diagnosed Stage II – IV DLBCL patients with a complete response after the standard six courses of R-CHOP. They will be randomized between observation and ZEVALIN treatment.
“Initiation of the ZEST trial, together with our commitment to the ongoing SPINOZA trial in patients with relapsed DLBCL who receive autologous stem cell transplantation, represent a comprehensive clinical program to determine the full potential of ZEVALIN in DLBCL, the most common form of non-Hodgkin’s lymphoma in which there is substantial unmet need, especially in older patients,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc.
Dr. Shrotriya continued, “Spectrum has a number of near-term and long-term clinical milestones for ZEVALIN, including presentations at major medical meetings, both internationally and in the US, such as at ASH and ASCO. In addition, a patient initiative launched earlier this year and the acquisition of marketing rights in the EU should have a strong impact on increasing awareness of the value of this important product for the global lymphoma community.”
Paul Hamlin, M.D., of the Lymphoma Service at Memorial Sloan-Kettering Cancer Center and a lead investigator in the study, commented, “There is a substantial need for better treatments for DLBCL, particularly in the ever-increasing group of older patients who have fewer treatment options than younger patients. A consolidative therapy that is administered in just one week and improves survival would have a huge impact on lymphoma patients’ lives. The very encouraging evidence from earlier Phase 2 studies of ZEVALIN in aggressive lymphomas, both in terms of safety and efficacy results, form the basis for the randomized study, and ZEVALIN has the potential to expand our arsenal against this terrible disease.”