On July 19, 2022 VBL Therapeutics (Nasdaq:VBLT), a biotechnology company developing targeted medicines for cancer and immune-inflammatory diseases, reported top-line data from the Phase 3 OVAL clinical trial of ofra-vec (ofranergene obadenovec; VB-111) in platinum-resistant ovarian cancer (Press release, VBL Therapeutics, JUL 19, 2022, View Source [SID1234616764]). The trial did not meet the primary endpoints of achieving a statistically significant improvement in progression-free survival (PFS) or overall survival (OS).
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The OVAL trial demonstrated that patients randomized to the combination of ofra-vec and paclitaxel had a median PFS of 5.29 months, versus 5.36 months for the paclitaxel control arm (HR=1.03). The interim overall survival analysis was also not significantly different between the two study arms (median OS 13.37 months in the treatment arm versus 13.14 months in the control arm; HR= 0.97) and did not support study continuation.
"Given the urgent unmet need for those fighting platinum-resistant ovarian cancer, we are deeply disappointed that the top-line data indicate that ofra-vec did not improve progression free survival or overall survival," said Prof. Dror Harats, M.D., chief executive officer of VBL Therapeutics. "Based on this outcome, we plan to discontinue the OVAL trial and will review the data from our ongoing Phase 2 trials in metastatic colorectal cancer and recurrent glioblastoma multiforme to determine next steps with the ofra-vec program. We extend our deepest gratitude to all the patients, families and healthcare professionals who participated in this trial."
As VBL evaluates next steps with the ofra-vec program, it continues to move the VB-601 program forward towards a first-in-human clinical trial, expected to begin in the fourth quarter of 2022. The Company anticipates that its current cash on hand will be sufficient to fund planned operations for at least the next 12 months.
About the OVAL Phase 3 Clinical Trial
OVAL (VB-111-701/GOG-3018) was an international, Phase 3, randomized, double-blind, placebo-controlled, clinical trial comparing a combination of ofra-vec (ofranergene obadenovec; VB-111) plus paclitaxel to placebo plus paclitaxel in 409 adult patients with recurrent platinum-resistant ovarian cancer. The two primary endpoints of the trial were progression free survival (PFS) and overall survival (OS). OVAL was conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies. For more information, refer to Clinicaltrials.gov NCT03398655.