FDA Grants Fast Track Designation to VB-111 for Platinum-Resistant Ovarian Cancer
This is excerpted from an article in OncLive by Chris Ryan April 22, 2022
The FDA has granted a fast track designation to VB-111 (ofranergene obadenovec), a targeted anticancer viral gene therapy, for use as a potential therapeutic option in patients with platinum-resistant ovarian cancer. VB-111 is designed to use a dual mechanism to target a wide range of solid tumors, including ovarian cancer. The mechanism pairs the blockade of tumor vasculature with an antitumor immune response. Prior data from a phase 1/2 trial (NCT01711970) indicated that when VB-111 was combined with paclitaxel in this patient population, it was efficacious and safe. Among the 21 patients enrolled to the trial, approximately half had platinum-refractory disease and half previously received treatment with antiangiogenics.... The combination is currently under further exploration in the phase 3 OVAL trial (NCT03398655), where it is being compared with paclitaxel alone in patients with recurrent platinum-resistant ovarian cancer. “We are pleased to receive FDA fast track designation for [VB-111] in platinum-resistant ovarian cancer. The fast track designation can facilitate the process toward potential registration and, importantly, may help expedite the time to market for [VB-111], if approved,” Dror Harats, MD, chief executive officer of VBL Therapeutics, stated in a press release. “The readout of the PFS primary end point in the OVAL trial will be an important milestone for VBL in the second half of . We believe that, if positive, this will support a biologics license application submission to the FDA.” OVAL recently completely enrollment of 409 patients, and the trial is being conducted at cancer centers throughout the United States, Europe, Israel, and Japan.