VBL Therapeutics Announces Peer-reviewed Publication of Positive Results of Pre-specified Interim Analysis of OVAL, a Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer

• Analysis shows a CA-125 response of at least 58% in the VB-111 treatment arm
• Published online in Gynecologic Oncology

TEL AVIV, Israel, March 04, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced the online publication of positive results of the pre-specified interim analysis of the OVAL study, a Phase 3 registration enabling study of VB-111 (ofranergene obadenovec) in recurrent platinum-resistant ovarian cancer. The analysis showed a CA-125 GCIG response rate of 58% or higher in evaluable patients in the VB-111 treatment arm. Based on the results of the interim analysis, the Data and Safety Monitoring Committee (DSMC) recommended continuing the trial as planned. The results were published online in the international peer reviewed journal Gynecologic Oncology (https://doi.org/10.1016/j.ygyno.2021.02.014).

“The goal of this interim analysis was to get a signal of drug activity, using CA-125 as a validated biomarker,” said Bradley J. Monk, M.D., FACOG, FACS, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Head of the OVAL steering committee and author on the manuscript. “The intention was to reduce the risk of a negative trial and increase the chance of success. New and novel approaches that have the potential to significantly extend progression free survival or survival are eminently required in platinum-resistant ovarian cancer. VB-111, with its very unique mechanism of action, could be one of those novel approaches and I look forward to the progress of the OVAL trial, which is well designed to test this hypothesis.”

The article reported results of the pre-specified interim analysis in the OVAL study, which reviewed unblinded data and assessed CA-125 response, measured according to the GCIG criteria, in the first 60 enrolled subjects evaluable for CA-125 analysis. Based on the overall response rate in the first 60 patients across both arms of 53%, and assuming balanced randomization and an absolute advantage of 10% or higher to the VB-111 arm, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) was calculated to be 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate was 69%. The futility rule determined for this analysis was that the response rate of VB-111 must be greater than the response rate of placebo by at least 10% in order to continue the study. This rule was successfully met.