On March 4, 2021 VBL Therapeutics (Nasdaq: VBLT) reported 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 (Press release, VBL Therapeutics, MAR 4, 2021, View Source [SID1234576056]). 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 (View Source).
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"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.
"We believe VB-111’s unique dual mechanism of action has the potential to prolong life and possibly turn certain cancers into manageable chronic diseases," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The encouraging trajectory of the OVAL trial, not only as reported in this paper but also based on the pre-specified DSMC reviews, makes us hopeful that VB-111 may have a meaningful impact on ovarian cancer."
About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal registration enabling 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 an investigational 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 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970).