Phase III GLOBE study of VB 111 + Avastin fails to meet endpoint in glioblastoma.- VBL Therapeutics.
VBL Therapeutics reported top-line results from its pivotal Phase III GLOBE study in patients with recurrent glioblastoma (rGBM) which was designed to evaluate VB 111 in combination with Avastin (bevacizumab), compared to the bevacizumab control arm. The study did not meet its pre-specified primary endpoint of overall survival (OS).
Comment: VB 111 has demonstrated statistically significant OS and PFS in a Phase II trial in patients with rGBM, versus current standard of care. VB 111 has received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. In addition, VB 111 successfully demonstrated proof-of-concept and survival benefit in Phase II clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum resistant ovarian cancer. VB 111 has received an Orphan Designation for the treatment of ovarian cancer by the European Medicines Agency.
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