On June 3, 2019 VBL Therapeutics (Nasdaq: VBLT), reported that MRI data from VB-111 Phase 2 and Phase 3 studies in recurrent GBM (rGBM), presented yesterday at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, showed a survival benefit associated with objective responses to the compound and a distinct signature of VB-111 activity (Press release, VBL Therapeutics, JUN 3, 2019, View Source [SID1234536818]). The data were presented by Dr. Benjamin M. Ellingson, Ph.D., from the UCLA Brain Tumor Imaging Laboratory (BTIL), Department of Radiological Science.
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The UCLA analysis compared data from VBL’s Phase 2 study of VB-111, which met the primary endpoint of OS benefit with a median OS (mOS) of 414 days, to MRI data from the treatment arm in the GLOBE Phase 3 study, which had a mOS of 6.8 months, despite similar baseline tumor volume between patient cohorts. The goal of the analysis was to investigate the difference between the trial outcomes, using quantitative radiographic tools.
There was a notable difference in the regimens between the studies: in the Phase 2 study, VB-111 was administered first as a single agent therapy (`priming`), with bevacizumab added to VB-111 upon further progression; in contrast, the GLOBE Phase 3 study regimen included co-administration of VB-111 and bevacizumab (Avastin) from the start of study therapy without any VB-111 monotherapy `priming` period.
"Our analyses revealed that responders to VB-111 monotherapy or combination therapy after priming with VB-111 exhibited characteristic, expansive areas of necrosis in areas of initial disease, which are related to the VB-111 mechanism of action," said Dr. Ellingson. "Some patients had clear evidence of response to VB-111 while others showed pseudo-progression, potentially linked to edema and local immune response induced by VB-111, which may have been misinterpreted as disease progression. The data show that responders to VB-111 treatment had a statistically significant survival advantage compared to non-responders."
"This analysis provides independent, quantitative evidence that priming with VB-111 has clinically-meaningful activity in rGBM, which can be seen by MRI signature, and is correlated with a statistically significant survival advantage," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We believe this work supports our view that VB-111 has therapeutic potential in rGBM and other difficult to treat and aggressive cancers. The VB-111 program in rGBM is now being advanced in an investigator-sponsored study at leading neuro-oncology centers in the U.S. VBL is also conducting a potential registration study of VB-111 in ovarian cancer, OVAL."
For additional information see: ASCO (Free ASCO Whitepaper) 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.