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ASH: New Analysis Confirms Most Complete Remissions in Follicular non-Hodgkin's Lymphoma Persist for Years Following Single Treatment with Bexxar (Tositumomab and Iodine I 131 Tositumomab) MISSISSAUGA, ON -- December 15, 2003 -- According to several studies presented this weekend at the 45th Annual Meeting of the American Society of Hematology (ASH), Bexxar™ (Tositumomab and Iodine I 131 Tositumomab) is active in a variety of patients with difficult-to-treat lymphomas, including patients with heavily pre-treated follicular non-Hodgkin's lymphoma who have had multiple relapses. Not yet available to Canadians, Bexxar has been granted a priority review by Health Canada, for use in a single course for the treatment of patients with B-cell, follicular, non- Hodgkin's lymphoma, with and without transformation, whose disease has relapsed following or is refractory to chemotherapy, or is refractory to Rituximab. Priority review status is reserved for new drugs that have the potential ability to address serious or life-threatening conditions and unmet medical needs. New Analysis of Durable Complete Responses Researchers presented a new analysis of the data on independently confirmed long-term durable responses, defined as responses with a time to progression of 12 or more months, from the five clinical trials that supported U.S. regulatory approval of the Bexxar therapeutic regimen. Of 230 patients with relapsed or refractory non-Hodgkin's lymphoma who were treated with Bexxar and were evaluable for response, 55 (24 per cent) met the definition of a durable complete response (complete resolution of radiological abnormalities and disappearance of signs and symptoms related to the disease). Investigators reported that 75 per cent of these patients (41/55) still showed no sign of disease after a median follow-up of nearly five years. Independently assessed durable complete responses were noted with similar frequency in patients who relapsed after or who were refractory to Rituximab therapy and in patients who had not received Rituximab prior to the Bexxar therapeutic regimen. "These data confirm that of the 20 to 25 per cent of patients with follicular non-Hodgkin's lymphoma treated with Bexxar who achieved a complete response lasting a minimum of 12 months, the majority remained in complete response with a median follow-up of nearly five years," Morton Coleman, MD, director, Center for Lymphoma and Myeloma, Weill Medical College of Cornell University and the New York Presbyterian Hospital, who presented the analysis. "For these patients, who have experienced multiple relapses and endured several courses of re-treatment, getting five or more disease-free and treatment-free years from a single, short course of therapy is very encouraging." About the Bexxar Therapeutic Regimen Bexxar is a dual-action therapy that pairs the tumor-targeting ability of an antineoplastic (cancer killing) monoclonal antibody (Tositumomab) and the therapeutic potential of radiation (Iodine-131) with patient-specific dosing. Combined, these agents form a radiolabeled monoclonal antibody (Iodine I 131 Tositumomab) that is able to bind to the target antigen CD20 found on non-Hodgkin's lymphoma cells, thereby initiating an immune response against the cancer and delivering a dose of radiation directly to tumor cells. Bexxar is the only non- Hodgkin's lymphoma therapy that is specifically dosed based on an individual's drug clearance rate, allowing the delivery of a pre-determined amount of radiation to each patient. The Bexxar therapeutic regimen, which has been studied for over 10 years, has demonstrated independently confirmed durable responses (responses with a time to progression of at least 12 months) in heavily pre-treated patients with follicular non-Hodgkin's lymphoma. In a clinical trial in patients who had a median of four prior chemotherapies and who had Rituximab-refractory disease, 63 per cent responded to Bexxar. Half of these patients had a response that lasted 25 months or longer. Determination of clinical benefit of the Bexxar therapeutic regimen was based on evidence of durable responses without evidence of an effect on survival. The most common adverse reactions occurring in clinical trials of the Bexxar therapeutic regimen included neutropenia, thrombocytopenia and anemia that could be both prolonged and severe but were generally reversible. The most common non-hematologic side effects included asthenia (weakness), fever, nausea, infection, and cough. The Bexxar therapeutic regimen was associated with a risk of hypothyroidism and human anti-murine antibody (HAMA) formation. Bexxar has been associated with the development of myelodysplasia (MDS), secondary leukemia and solid tumors. Bexxar carries a warning about infusion-related reactions that may be induced by the administration of foreign proteins. Hypersensitivity reactions occurred in six per cent of patients. Adjustments of the rate of infusion to control adverse reactions occurred in seven per cent of patients. Unlike chemotherapy, or even antibody therapy, Bexxar is given in a single, short course of outpatient treatment, individualized for each patient. The Bexxar therapeutic regimen consists of two steps performed in four visits over seven to 14 days. "The results show that Bexxar has a real potential to be an effective treatment even for refractory non-Hodgkin's Lymphoma patients for whom the therapy represents a last resort. In the trials, 20 per cent of this least-likely to respond treatment group unexpectedly altered the natural history of the disease," says Dr. Connors, Chair, Lymphoma Tumor Group, BC Cancer Agency and Clinical Professor of Medical Oncology at the University of British Columbia. About Non-Hodgkin's Lymphoma Non-Hodgkin's lymphoma is a form of cancer that affects the blood, bone marrow and lymphatic tissues. Unlike most major forms of cancer, both incidence and mortality rates of NHL are increasing. According to the National Cancer Institute of Canada, approximately 6,300 new cases of non-Hodgkin's lymphoma were diagnosed last year in Canada alone. In 2002, 2,800 Canadians died of the disease.1 6,400 new cases are estimated by the end of this year. Incidence rates for NHL in Canada have more than doubled over the last thirty years and are among the highest in the world.1 Transformed non-Hodgkin's lymphoma is an aggressive and difficult to treat form of follicular non-Hodgkin's lymphoma with a particularly poor prognosis. SOURCE: GlaxoSmithKline NATIONAL PharmaCom E-mail this page to a friend or colleague! To print, use this version