Phase III GLOBE Study continues for ofranergene obadenovec (VB-111) in recurrent glioblastoma (rGBM).- VBL Therapeutics

VBL Therapeutics announced that the Independent Data Safety Monitoring Committee (DSMC) met to conduct its second safety review of the Phase III GLOBE Study investigating ofranergene obadenovec (VB-111) in recurrent glioblastoma (rGBM). The DSMC is an independent multidisciplinary group that conducts detailed reviews of un-blinded study data, discusses potential safety concerns and provides recommendations regarding trial continuation. The committee reviewed the GLOBE safety data collected through a cutoff date in March 2017 and unanimously recommended that the study continue as planned.

The Phase III GLOBE study in rGBM is comparing VB-111 in combination with Avastin (bevacizumab) to Avastin alone and has recruited 256 patients in the US, Canada and Israel. The study is proceeding under a Special Protocol Assessment (SPA) granted by the FDA, with full endorsement by the Canadian Brain Tumor Consortium (CBTC). VB-111 has received orphan drug designation in the United States and Europe and was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation.

Ofranergene obadenovec completed a Phase II study in rGBM, which showed a statistically significant improvement in overall survival in patients treated with ofranergene obadenovec through progression, compared to either patients treated with ofranergene obadenovec followed by bevacizumab alone, or to historical bevacizumab data. In a Phase II trial for recurrent platinum-resistant ovarian cancer, ofranergene obadenovec demonstrated a statistically significant increase in overall survival and 60% durable response rate (as measured by reduction in CA-125), approximately twice the historical response with bevacizumab plus chemotherapy in ovarian cancer. In a Phase II study in recurrent, iodine-resistant differentiated thyroid cancer, ofranergene obadenovec met the primary endpoint and provided evidence of disease stabilization with a positive safety profile, along with a dose-response and evidence of an overall survival benefit.