VBL presents positive interim data from the OVAL phase III pivotal study of VB 111 in ovarian cancer at the ASCO meeting, showing 58% or higher objective response rate

VBL Therapeutics announced the presentation of the positive outcome of pre-planned interim analysis results from the OVAL Phase III pivotal clinical trial of VB III in platinum-resistant ovarian cancer at the American Society of Clinical Oncology (ASCO) 2020 virtual annual meeting. The analysis compared the CA-125 objective response rate (ORR) according to GCIG criteria in the treatment and control arms among the first 60 evaluable patients.

The CA-125 ORR in those patients 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 CA-125 response rate observed in the Phase III interim analysis is at least as good as the response rate seen in the prior Phase II study, which enrolled a similar patient population and showed overall survival benefit.

In the previously reported Phase II 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 a CA-125 response.“The OVAL interim data are very encouraging as they demonstrate the potential benefit of VB 111 over standard-of-care in a randomized-controlled setting,” said Tami Rachmilewitz, M.D., Vice President Clinical Development of VBL Therapeutics. “With over 25% of the patients already enrolled in the study, we look forward to further advancing the OVAL study by expansion to Europe and Japan later this year.”

About the OVAL (VB 111-701/GOG-3018) study (NCT03398655) : OVAL is an international Phase III randomized, double-blind, placebo-controlled 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.