GlaxoSmithKline has released encouraging long-term efficacy data from a phase II trial of a single one-week course of frontline treatment with the Bexxar therapeutic regimen in 76 patients with newly diagnosed advanced follicular non-Hodgkin's lymphoma.
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This regimen (tositumomab and iodine I-131 tositumomab) was found to induce durable clinical and molecular remissions in patients with the disease. Specifically, researchers reported that patients who received a single one-week treatment of Bexxar as monotherapy achieved estimated eight-year and 10-year overall survival rates of 86%. In addition, 50% of patients survived without progression of disease at eight 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.
“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,” commented Mark Kaminski, professor of internal medicine and director of the leukemia/lymphoma program at the University of Michigan and lead investigator of this study.
The data was presented at the 2007 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois. Additional data presented in an oral presentation at ASCO demonstrated that adding Bexxar to BEAM chemotherapy as a conditioning regimen prior to autologous stem cell transplant in patients with relapsed or high-risk chemosensitive diffuse large B-cell lymphoma resulted in 78% of the patients achieving a complete remission following the transplant.
GSK also presented data on the cost-effectiveness of Bexxar in the treatment of non-Hodgkin’s lymphoma. In this analysis, Bexxar was shown to have a favorable cost-effectiveness profile compared to alternative treatments, including chemotherapy, Biogen Idec’s Zevalin (ibritumomab tiuxetan), and maintenance rituximab.