March 26, 2015
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VB-111 plus bevacizumab confers positive interim results in recurrent glioblastoma

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Interim results from an ongoing phase 2 study demonstrated that patients with recurrent glioblastoma who received VB-111 alone and subsequently with bevacizumab achieved significantly improved OS compared with patients who received VB-111 followed by bevacizumab monotherapy, according to a press release from the drug’s manufacturer.

Researchers evaluated VB-111 (VBL Therapeutics) — the first agent based on transcriptional targeting of tumor endothelium to be assessed in a clinical trial — in 46 patients with recurrent glioblastoma. Patients received VB-111 alone until disease progression. Twenty-two patients were then treated with bevacizumab (Avastin, Genentech) monotherapy. Of the 24 remaining patients, 23 chose to receive further treatment with VB-111 plus bevacizumab. One patient remains stable on VB-111 alone at 424 days.

The combination of VB-111 and bevacizumab demonstrated a statistically significant improvement in OS. Median OS was 414 days in patients who received the combination compared with 235 days in patients who received VB-111 monotherapy followed by bevacizumab monotherapy (P = .05).

VBL Therapeutics plans to commence a phase 3 trial evaluating VB-111 in 2015. The trial — to be led by Timothy Cloughesy, MD, professor of clinical neurology and director of neuro-oncology programs at UCLA School of Medicine — has received a special protocol assessment from the FDA.

"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,” Dror Harats, MD, chief executive officer of VBL Therapeutics, said in a press release. “We believe VB-111'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. We continue to work to bring VB-111 forward as a potential new treatment option, and look forward to initiating a pivotal phase 3 trial in recurrent glioblastoma later this year."