VBL Therapeutics announces peer-reviewed publication of positive results of pre-specified interim analysis of OVAL, a phase III registration enabling study of VB 111 in ovarian cancer.

VBL Therapeutics announced the online publication of positive results of the pre-specified interim analysis of the OVAL study, a Phase III 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 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.