VB-111, is a targeted anti-cancer biologic agent that is positioned to potentially treat a wide range of solid tumors indications.
Following successful Phase 2 study, VB-111 was advanced to a Phase 3 trial in rGBM.
GLOBE was a controlled, double-arm, open-label Phase 3 study designed to evaluate our therapeutic candidate VB-111 in combination with bevacizumab (also known as Avastin) in patients with recurrent glioblastoma.
In March 2018, we announced top-line results from the GLOBE study, which showed that the study did not meet its pre-specified primary endpoint of overall survival (OS) or the secondary endpoint of progression-free survival (PFS).
The full study data were presented at the 2018 Society for Neuro-Oncology Annual Meeting by Dr. Timothy Cloughesy, MD, Professor of Clinical Neurology and Director of the Neuro-Oncology Program, UCLA School of Medicine and principal investigator of the GLOBE trial.
- Thorough analyses of the baseline risk factors of the Phase 2 and the Phase 3 treatment groups did not reveal any differences. Therefore, patient selection or different patient populations could not explain the difference between the results of the two studies. The only significant change between the Phase 2 and Phase 3 treatment cohorts was in the treatment regimen – the regimen for Phase 2 trial included `priming` with VB-111 whereas the regimen for GLOBE trial did not.
- Data suggest that concomitant treatment with bevacizumab may have a negative effect on VB-111 activity. The Company believe that priming with VB-111 without bevacizumab may be critical for the immune and vascular-disruptive/anti-angiogenic mechanism of VB-111 in rGBM.
We do not think that results of the particular GLOBE study that investigated VB-111 in combination with bevacizumab in rGBM, will necessarily have implications on the prospects for VB-111 in other tumor types, in different patients populations, or in different regimens.
The company is currently evaluating the path forward of VB-111 in rGBM, including the option of an investigator-initiated clinical trial.