GlaxoSmithKline plc [LSE and NYSE: GSK] announced long-term efficacy data from a Phase II trial of a single one-week course of frontline treatment with the BEXXAR? 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 Universityof Michiganand 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, 2005).
?These data contribute to the growing body of evidence supporting the effectiveness of BEXXAR,? said David Moules, Vice President, Oncology, GlaxoSmithKline. ?GSK is proud to be a leading developer of new medicines, like BEXXAR, for patients battling lymphoma, and these results support our ongoing development plan investigating additional patient populations that may benefit from this important therapy.?
Additional data presented in an oral presentation at ASCO (Abstract #8013) demonstrate that adding BEXXAR to BEAM (BCNU, etoposide, ara-C, and melphalan) chemotherapy as a conditioning regimen prior to autologous stem cell transplant (ASCT) in patients with relapsed or high-risk chemosensitive diffuse large B-cell lymphoma (DLBCL) resulted in 78% of the patients achieving a complete remission following the transplant. Threeyear PFS and OS were 70% and 81%, respectively. These results compare favorably with previous studies of BEAM alone followed by ASCT. Compared to a similar cohort receiving BEAM alone, no increased toxicity could be detected.2
Data on the cost-effectiveness of BEXXAR in the treatment of NHL were also presented at ASCO (Abstract #8089). In this analysis, BEXXAR was shown to have a favorable cost-effectiveness profile compared to alternative treatments, including chemotherapy, ZEVALIN? (Ibritumomab Tiuxetan), and maintenance Rituximab.3