On September 16, 2024 TME Pharma N.V., a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported an oral presentation by Dr. Frank A. Giordano, lead investigator of the NOX-A12 GLORIA Phase 1/2 trial in first-line brain cancer (glioblastoma), taking place on Sunday, September 15, 2024, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona, Spain (Press release, TME Pharma, SEP 16, 2024, View Source [SID1234646633]). The presentation provided the updated results and key conclusions from the combined therapy with NOX-A12 and bevacizumab in newly diagnosed glioblastoma patients resistant to standard chemotherapy (MGMT unmethylated) with residual detectable tumor after surgery.
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In the presentation, Dr. Giordano highlighted that inhibition of two paths of brain tumor revascularization after radiation – vasculogenesis with NOX-A12 and angiogenesis with bevacizumab – resulted in deeper clinical responses, i.e. stronger shrinkage of tumor size compared to NOX-A12 therapy alone. The research showed a significant decrease in tumor perfusion which supports the suggested mode of action of the combination therapy. The presentation also reveals that the deeper responses to the combination therapy with NOX-A12 and bevacizumab translate to significantly longer median progression free survival (mPFS: 9.1 months, p=0.003) and median overall survival (mOS: 19.9 months, p=0.005) compared to a matched SOC reference cohort (mPFS: 4.0 months; mOS: 9.5 months) or to NOX-A12 alone (mPFS: 5.7 months; mOS: 12.7 months). Two out of the six glioblastoma patients in the NOX-A12 + bevacizumab arm of the GLORIA trial survived for more than 26 months since the start of therapy.
"The median OS of 19.9 months achieved in patients receiving combination therapy in the GLORIA study is especially exciting when considering the prognosis this chemotherapy-refractory patient population with residual detectable tumor after surgery would otherwise face on current standard of care, notably survival of approximately 10 months," said Aram Mangasarian, CEO of TME Pharma. "What further strengthens our confidence in our dual inhibition approach is the tumor tissue analysis showing spatially distinct expression patterns of NOX-A12’s target CXCL12 and VEGF. This indicates that the two different ways of growing blood vessels occur in different tumor structures: vasculogenesis driven by NOX-A12’s target, and angiogenesis driven by bevacizumab’s target. This helps explain why combined inhibition of both pathways is needed to effectively prevent tumor vasculature restoration after radiotherapy."
Details of the oral presentation at the ESMO (Free ESMO Whitepaper) Congress 2024 are as follows:
Title: Dual inhibition of postradiogenic angio-vasculogenesis in glioblastoma: Results of the phase 1/2 GLORIA trial
Presenter: Dr. Frank A. Giordano, Chair of the Department of Radiation Oncology, University Medical Center Mannheim, Germany
Session: Mini oral session: CNS tumors
Time and Date: 08.30-8.35 a.m. CEST, Sunday, September 15, 2024