VBL Therapeutics announces second successful pre-planned interim analysis with a positive data safety monitoring committee review looking at OS - the primary endpoint of the OVAL Phase III potential registration study of VB 111 in Ovarian Cancer.

VBL Therapeutics announced that the independent Data Safety Monitoring Committee (DSMC) has completed its second, pre-planned interim analysis in the ongoing OVAL Phase III study investigating ofranergene obadenovec (VB 111) in patients with platinum-resistant ovarian cancer, and unanimously recommended that the study continue as planned. In this second interim analysis, the DSMC reviewed unblinded Overall Survival (OS) data of the first 100 randomized patients with a follow up of at least 3 months. OS is the primary endpoint of the OVAL study. The committee also looked at response rate and safety information. In March 2020, the Company announced results of the first 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. The overall response rate in the first 60 randomized evaluable patients across both arms was 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB 111 in addition to weekly paclitaxel) was 58% or higher. In patients who had post-dosing fever, which is a marker for VB 111 treatment, the response rate was 69%. The next DSMC review in the OVAL study is expected in the first quarter of 2021.