8-Year Long-term Data Demonstrate Prolonged Overall Survival and,Length of Disease Remission with Bexxar ( Positive Results in Patients With Folli...)

8-Year Long-term Data Demonstrate Prolonged Overall Survival and,Length of Disease Remission with Bexxar

Positive Results in Patients With Follicular Lymphoma Reported Today at ASCO Annual Meeting

PHILADELPHIA, June 04, 2007 /PRNewswire/ -- GlaxoSmithKline plc announced today long-term efficacy data from a Phase II trial of a single one-week course of frontline treatment with the BEXXAR(R) Therapeutic Regimen (Tositumomab and Iodine I-131 Tositumomab) in 76 patients with newly diagnosed advanced follicular non-Hodgkin's lymphoma (NHL). This regimen was found to induce durable clinical and molecular remissions in patients with this disease. Specifically, researchers reported that patients who received a single one-week treatment of BEXXAR as monotherapy achieved estimated 8-year and 10-year overall survival (OS) rates of 86%. Additionally, 50% of patients survived without progression of disease at 8 years following therapy. For patients who achieved complete remission, the median time before their disease progressed was 9.2 years. An overall response rate and complete remission rate of 95% and 75%, respectively, were observed. These data were presented today at the 2007 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois (Abstract #8033).(1)

"For years we have known that radioimmunotherapy, such as BEXXAR, is an effective treatment for patients with relapsed or refractory lymphoma. The data from this frontline study suggest that BEXXAR may also have activity when used as a frontline treatment and should be studied further in this setting. Of note, these results were achieved with BEXXAR given as a single treatment, completed within one week, which made it a convenient regimen for these patients," said Mark Kaminski, Professor of Internal Medicine and Director, Leukemia/Lymphoma Program at the University of Michigan and lead investigator of this study.

The five-year follow-up data from this study were originally reported in the New England Journal of Medicine (NEJM 352:441,
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