VB-111 Clinical Data Presented at ASCO Demonstrate Significant Increase in Overall Survival in Platinum-Resistant Ovarian Cancer
- VB-111 demonstrated a statistically significant increase in overall survival at therapeutic vs. low dose level (810 days vs. 172 days, p=0.042)
- 60% (9 of 15) durable response rate (as measured by reduction in CA-125) observed with VB-111, approximately 2x the historical response with Avastin® plus chemotherapy in ovarian cancer
- Clinical data supported by immunotherapeutic effect observed in biopsies following treatment with VB-111
“The demonstration of improved overall survival with the therapeutic dose, in combination with 60% durable response rate, is particularly impressive, given this trial focused on women with poor prognosis disease,” said Richard Penson, MD, MRCP, Associate Professor of Medicine, Harvard Medical School, Clinical Director of Medical Gynecologic Oncology, Massachusetts General Hospital, and Primary Investigator for this trial.
“We are excited by this data set from our Phase 1/2 ovarian cancer trial which show durable disease control and responses with VB-111,” said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. “The data reinforce our confidence in VB-111 as, together with the positive data we have generated in GBM, this is the second cancer indication in which we have observed a significant survival benefit. We are now preparing for an end-of-Phase 2 meeting with the
This trial was designed as a Phase 1/2 dose escalation study. The primary objectives were to evaluate the safety and tolerability and identify dose limiting toxicity in combination of VB-111 and weekly paclitaxel; and explore the efficacy in an expanded cohort of the optimally tolerated dose of combination VB-111 and weekly paclitaxel, based on RECIST response, CA-125 response, progression free survival (PFS) and overall survival (OS) in patients with recurrent platinum-resistant ovarian cancer.
Twenty one patients with recurrent platinum-resistant Müllerian/ovarian cancer were enrolled at
The results showed a significant increase in overall survival at the therapeutic dose of VB-111 vs. the low dose level (810 vs. 172 days, p=0.042). Nine of the 15 evaluable patients (60%) on the therapeutic dose had a response, as defined by a 50% reduction in CA-125. Durable RECIST responses and disease stabilizations were seen. This represents an approximate doubling in response rate, compared to historical data with ovarian cancer patients treated with a combination of Avastin® and chemotherapy in the AURELIA1 trial.
An immunotherapeutic effect was also observed in biopsies taken from patients. H&E and immunohistochemistry staining showed regions of apoptotic cancer cells and infiltration of cytotoxic CD8 T-cells following treatment with VB-111.
VB-111 was found to be safe and well tolerated. Toxicity was similar to what would be expected with antiangiogenics and taxanes in this patient population. Eight serious adverse events were reported, 2 were considered by the investigator to be possibly related to be VB-111. No dose limiting toxicities were reported at any dose level.
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- AURELIA was an open-label randomized phase III trial designed to determine the efficacy, safety, and quality of life of combining bevacizumab (Avastin®) with chemotherapy for platinum-resistant recurrent ovarian cancer.
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