VBL Final Phase 1/2 Study Results Presented at ASCO Demonstrate VB-111 Dose Dependent Increase in Overall Survival and 58% CA-125 Response Rate in Platinum-Resistant Ovarian Cancer
- VB-111 demonstrated a statistically significant increase in overall survival at therapeutic vs. low dose (498 days vs. 172.5 days, p=0.03)
- CA-125 response (GCIG) was reported in 58% of evaluable patients and was predictive of overall survival, in patients treated with a therapeutic dose of VB-111
- Post treatment tumor infiltrating CD8 T-cells and apoptotic cancer cells indicated tumor transformation from immunologically ‘cold’ to ‘hot’, possibly contributing to the favorable clinical outcomes
- Fever response to VB-111 occurred in 29% of patients and was associated with favorable overall survival
TEL AVIV, Israel, June 03, 2019 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced the presentation of the final results from a Phase 1/2 clinical trial of VB-111 in the treatment of patients with recurrent platinum resistant ovarian cancer on Saturday, June 1st at the 2019 American Society of Clinical Oncology (ASCO) annual meeting, in Chicago.
Data demonstrated a median overall survival (OS) of 498 days in the VB-111 therapeutic-dose arm, versus 172.5 days in the low-dose arm (p=0.03). 58% of evaluable patients treated with the therapeutic dose of VB-111 had a GCIG CA-125 response. In comparison, in the AURELIA trial, the GCIG CA-125 response rate was 31.8% with bevacizumab and chemotherapy, and only 11.6% with chemotherapy alone.
VB-111 activity signals were seen despite unfavorable prognostic characteristics (50% platinum refractory disease and 50% previous treatment with anti-angiogenics). There was a trend for favorable survival in patients who had CA-125 decrease >50% in the VB-111 therapeutic-dose arm (808 vs. 351 days; p=0.067) implicating CA-125 as a valuable biomarker for response to VB-111. Post treatment fever was also associated with a signal for improved survival (808 vs. 479 days; p=0.27).
“The improved overall survival seen with the therapeutic dose of VB-111 is compelling, given that this trial focused on women with poor prognosis whose disease had progressed following several lines of prior therapies,” said Tami Rachmilewitz, M.D., Vice President Clinical Development of VBL Therapeutics. “The high CA-125 response rate, the long duration of responses and the recruitment of immune cells into the tumor provide additional evidence for activity of VB-111, and support its continued development in ovarian cancer.”
“These data reinforce our confidence in VB-111 as we continue to advance OVAL, our potential registration trial in platinum resistant ovarian cancer,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “Importantly, the data implicating CA-125 decrease as a biomarker for VB-111 activity can be valuable for our Phase 3 OVAL trial, for which an interim analysis is expected around year-end 2019. In addition, the ability of VB-111 to turn a notoriously `cold` tumor like ovarian cancer `hot` is suggestive that VB-111 may have broader applicability across additional cold tumors. We look forward to the launch of investigator-sponsored trials in rGBM and colon cancer to provide more data on the potential of VB-111.”
For additional information see: ASCO poster
About VB-111 (ofranergene obadenovec)
VB-111, a potential first-in-class anticancer therapeutic candidate, is the Company’s lead oncology product currently being studied in the OVAL potential-registration Phase 3 pivotal trial for ovarian cancer (ClinicalTrials.gov Identifier: NCT03398655). VB-111 has received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. In addition, VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970). VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission.
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. It is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a potential registration trial for platinum-resistant ovarian cancer.
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding our programs, including VB-111, including their clinical development, such as the timing thereof, therapeutic potential and clinical results, and the scope and protection of our intellectual property rights. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, the risk that historical clinical trial results may not be predictive of future trial results, and that we may not realize the expected benefits of our intellectual property protection. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the U.S. Securities and Exchange Commission, including in our annual report on Form 20-F for the year ended December 31, 2018, and subsequent filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
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