VBL Presents Positive Interim Data from the OVAL Phase 3 Pivotal Study in Ovarian Cancer at the ASCO20 Annual Meeting, Showing 58% or Higher Objective Response Rate
VBL Therapeutics (Nasdaq: VBLT), today announced the presentation of the positive outcome of pre-planned interim analysis results from the OVAL Phase 3 pivotal clinical trial 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 3 interim analysis is at least as good as the response rate seen in the prior Phase 2 study, which enrolled a similar patient population and showed overall survival benefit. 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 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.”
For VBL’s presentation at ASCO see: Link
Read the full press release here.