VBL Therapeutics Stock Jumps on Adding PFS as Second Independent Primary Endpoint in Ovarian Cancer Gene Therapy Trial

VBL Therapeutics Ltd VBLT has amended the primary endpoint in the OVAL Phase 3 registration-enabling study of VB-111 (ofranergene obadenovec) gene therapy for ovarian cancer.
Following discussion with the FDA, the clinical trial amendment includes a second, separate primary endpoint, of progression-free survival (PFS), in addition to the original primary endpoint of the trial, overall survival (OS).
Successfully meeting either PFS or OS primary endpoints is expected to be sufficient for submitting a BLA for potential full FDA approval.
Successful meeting of the PFS endpoint, with a readout anticipated in 2022, could accelerate marketing application submission by approximately one year compared to original projections based on the readout of the OS primary endpoint that remains anticipated in 2023.
The OVAL study amendment will be presented at the 2021 ASCO Annual Meeting.
OVAL is a Phase 3 randomized pivotal registration trial evaluating 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.
Price Action: VBLT shares are up 9.2% at $2.61 during the premarket session on the last check Thursday.