Current status of a phase III trial of nimotuzumab (ti-EGF-R) in newly diagnosed glioblastoma.

Abstract

2059 Background: The receptor for epidermal growth factor (EGF-R) has been one of the first molecules suspected to have a role in the glioma disease. Within the CNS it has exquisite selectivity for high grade glioma cells. A monoclonal antibody against EGF-R (nimotuzumab) and binding more specifically to highly over expressing cells has shown promise in preclinical and early clinical findings. Methods: Nimotuzumab was tested in an open label, randomized, multicenter Phase III trial in patients with newly diagnosed glioblastoma. OSAG 101 is administered by i.v. infusion (2 weekly infusions of 400mg) during the current standard radio chemotherapy followed by biweekly infusions of 400mg thereafter until progression. Only histologically confirmed glioblastoma patients were included and stratified for resection status. Primary endpoint was time to progression as determined by centralized neuro-imaging review. Overall survival serves as a secondary endpoint with quality of life and safety as additional paramete...