Israel’s VBL Therapeutics said that its experimental brain cancer drug met the main goal of improving overall survival in a mid-stage study.
The company announced top-line interim results from its ongoing Phase II study of investigational VB-111 in patients with recurrent glioblastoma (rGBM). According to VBL, the drug demonstrated a statistically significant improvement in overall survival (OS) in patients treated with VB-111 followed by VB-111 in combination with Genentech’s Avastin (bevacizumab) upon disease progression, compared to patients treated with VB-111 followed by Avastin alone upon disease progression.
VBL said that it will present detailed study results at the American Society of Cancer Oncology (ASCO) Annual Meeting, May 29th – June 2nd, 2015 in Chicago, IL.
The news sent VBL shares up 20 percent in premarket trade on Wednesday.
“We are extremely pleased by these interim results and are particularly excited to see a statistically significant improvement in overall survival in this needy patient population. We believe VB-811’s ability to curb disease progression in this devastating illness further reinforces its broad potential as a gene therapy for a range of solid tumor indications,” said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. “We continue to work to bring VB-811 forward as a potential new treatment option, and look forward to initiating a pivotal Phase 3 in recurrent glioblastoma later this year.”
The mid-stage study data include 46 patients with rGBM. VB-811 monotherapy was discontinued upon disease progression in 22 patients who were then treated with bevacizumab alone. The remaining 24 patients, upon disease progression on VB-111 monotherapy, could elect to receive further treatment with VB-811 in combination with Avastin. 23 patients received the combined therapy; one patient is still stable on VB-111 monotherapy at 424 days. The combination of VB-111 and Avastin demonstrated a statistically significant improvement in OS, with a median OS of 414 days compared to 235 days in patients on VB-111 followed by Avastin alone.
VB-111 is a novel, intravenously-administered, anti-angiogenic agent that utilizes VBL’s proprietary Vascular Targeting System (VTS) to target endothelial cells in tumor vasculature for cancer therapy. It is the first agent based on transcriptional targeting of tumor endothelium to be assessed in a clinical trial. The drug has received Fast Track Designation for rGBM in the US and orphan drug status for glioblastoma in both the US and EU.
Source: VBL Therapeutics
Last updated: 3/25/15; 9:40am EST