On August 12, 2020 VBL Therapeutics (Nasdaq: VBLT) reported that the independent Data Safety Monitoring Committee (DSMC) has completed its second, pre-planned interim analysis in the ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111) in patients with platinum-resistant ovarian cancer, and unanimously recommended that the study continue as planned (Press release, VBL Therapeutics, AUG 12, 2020, View Source [SID1234563484]).

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In this second interim analysis, the DSMC reviewed unblinded Overall Survival (OS) data of the first 100 randomized patients with a followup of at least 3 months. OS is the primary endpoint of the OVAL study. The committee also looked at response rate and safety information.

"We are pleased by the DSMC recommendation to continue the OVAL trial as planned," said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. "This is the second successful analysis in the OVAL study, which reviewed unblinded overall survival data comparing VB-111 to placebo. The OVAL study continues to show strong recruitment despite the COVID-19 pandemic, and we are very encouraged by the high response rate of over 50% of the trial participants, which has been maintained. This latest DSMC recommendation, together with the remarkable response rate observed in our first interim efficacy analysis and the survival benefit seen in the Phase 2 trial of VB-111 in patients with platinum-resistant ovarian cancer, support the confidence we have in OVAL. We are excited to advance VB-111 for the potential benefit of ovarian cancer patients."

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.

About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal potential registration clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies.

About VB-111 (ofranergene obadenovec)
VB-111 is a first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that uses a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 studies.VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970).