Interim analysis in phase III OVAL study of VB 111 shows positive outcome in ovarian cancer.- VBL Therapeutics

VBL Therapeutics announced an encouraging outcome of the planned interim analysis in the phase III OVAL study, a double-blind controlled potential-registration study in patients with platinum-resistant ovarian cancer given VB 111 (gene therapy) in addition to weekly paclitaxel. The OVAL independent Data Safety Monitoring Committee (DSMC), reviewed un-blinded data and assessed CA-125 response, measured according to the GCIG criteria, in the first 60 enrolled subjects evaluable for CA-125 analysis. The DSMC confirmed that the study met the interim pre-specified efficacy criterion, of an absolute percentage advantage of 10% or higher CA-125 response rate for the VB-111 treatment arm, and recommended the study continuance. The overall CA-125 response rate in the first 60 randomized evaluable patients is 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) is 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate is 69%. In the previously reported Phase 2 study of VB-111 in platinum resistant ovarian cancer, 58% of the patients treated with VB-111 and paclitaxel demonstrated a CA-125 response. Those patients with a CA-125 response demonstrated a median overall survival of 808 days, versus 351 days for those patients without CA-125 response. The DSMC recommendation that the OVAL trial proceed is not assurance that the trial will meet its primary endpoint. The primary endpoint of the OVAL Phase III study is overall survival, which currently approved therapies for platinum-resistant ovarian cancer have thus far failed to demonstrate.