AN UPDATE ON THE EFFECTS OF NEURADIAB ON PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME (GBM)
Posted on: 08/29/2008
Abstracts for the Thirteenth Annual Meeting of the Society for Neuro-Oncology
November 20–23, 2008
MA-104. AN UPDATE ON THE EFFECTS OF NEURADIAB ON PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME (GBM)
D. Reardon1, A. Ezrin2, Brian Brohman2, J. Karjalainen3, H. Dulude3,
J. Warren3, M. Zalutsky1, and D. Bigner1; 1Duke University Medical Center, Durham, NC, USA; 2Bradmer Pharmaceuticals, Miami, FL, USA; 3Bradmer Pharmaceuticals, Toronto, ON, Canada.
Neuradiab™ is a 131I-labeled anti-tenascin murine monoclonal antibody, previously described as mAb 81C6 and under evaluation as a novel therapy for GBM. Neuradiab is delivered directly into the surgically created resection cavity (SCRC) via a single intracavitary administration of target dose of 44 Gy. Neuradiab delivers a boost dose of radiation internal to the tumor by local delivery of 131I to a unique protein expressed in glioma cells. The therapy has been extensively evaluated in 10 previous GBM trials. Although the trials were not controlled, comparison of the survival rates achieved with historical controls was highly favorable in both recurrent and newly diagnosed patient populations. In two recent phase 2 trials, when Neuradiab was added to standard of care including surgery, temozolomide and XRT (study 01128, n = 21; and study 05018, n= 5) with targeted dose of 44 Gy, the overall survival was extended by over 40% in newly diagnosed GBM patients. The safety and efficacy in study # 01128 was previously reported, indicating a median overall survival of 91 weeks (Reardon et al., Neuro-Oncology April 2008) calculated as MOS from time of Neuradiab administration. A further analysis after 231 weeks of median follow-up revealed an average time to progression of 77.3 weeks (17.8 months) and an MOS of 102.1 weeks (n=14). An additional 5 GBM patients were studied with Neuradiab utilizing a patient-specific protocol, resulting in an overall increase in PFS of 74.6 weeks (17.2 months) and MOS 107.7 weeks (24.9 months). The difference in these data reflects an average time between diagnosis and treatment of 49 days in study 01128 (n=14 GBM) and 39 days in study 05018 (n=5). It is of interest that in the newly diagnosed GBM population treated with Neuradiab almost 50% of the population were alive at 2 years and that 10.5% were alive beyond 3 years. In a subset of patients with anaplastic astrocytoma (AA; n= 5) Neuradiab prolonged time to recurrence to 164 weeks. These data form the basis for the study design for the ongoing BRAD-301 GLASS-ART Trial currently enrolling newly diagnosed GBM patients.
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