On November 18, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that investigators from the GLORIA trial have presented a poster featuring a clinical update from the ongoing GLORIA Phase 1/2 trial studying NOX-A12, TME Pharma’s CXCL12 inhibitor, in combination with radiotherapy and anti-VEGF (bevacizumab), at the 2023 Society for Neuro-Oncology (SNO) Annual meeting, taking place in Vancouver, Canada, November 15-19, 2023 (Press release, TME Pharma, NOV 18, 2023, View Source [SID1234637798]).
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"The Society of Neuro-Oncology Annual Meeting is one of the year’s foremost international scientific conferences in the field of brain cancer, so it is a great forum for the clinical investigators leading the GLORIA trial to share NOX-A12’s latest impressive clinical achievements," said Aram Mangasarian, CEO of TME Pharma. "These unprecedented survival data demonstrate NOX-A12’s clinical potential and are providing the basis for our forthcoming discussions with regulators on the next steps for NOX-A12’s development in glioblastoma. We are looking forward to updating the market on our progress over the coming months, which we expect will include filings for an Investigational New Drug and expedited regulatory pathways."
The presentation, entitled "Interim data on dual inhibition of post-radiogenic angio-vasculogenesis by olaptesed pegol (NOX-A12) and bevacizumab in glioblastoma from the first expansion arm of the Phase 1/2 GLORIA trial", highlights the response, survival and safety data as of October 24, 2023, for patients with the aggressive adult brain cancer, glioblastoma, in the GLORIA expansion arm receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy. All patients recruited in this expansion arm have residual chemotherapy-refractory tumor detectable after maximal safe surgery.
The 67% survival at 18 months observed in patients treated with NOX-A12 + bevacizumab (anti-VEGF) + radiotherapy outperforms by 13-fold the 5% survival seen in the matched group of reference patients receiving standard of care1. At 18.3 months median follow-up, 50% of patients remain alive and the median overall survival is expected to improve further as patients continue to receive treatment or follow-up care2. For comparison, the matched standard of care reference cohort achieved a median overall survival of 10.5 months. Median progression-free survival for patients receiving the NOX-A12 combination regimen reached 9 months, compared to 4 months for the matched group of reference patients.
The radiographic response to treatment, which measures the change in size of target tumor lesions as response to treatment, was also highly encouraging with an overall response rate (ORR) of 100%. mRANO3 response, which also incorporates a clinical assessment, was 83.3%. One patient achieved complete response (CR) as per mRANO, meaning the tumor disappeared completely and was no longer detectable by MRI, and the patient was in good clinical condition. Two additional patients achieved a reduction in tumor size of more than 99%, leading to 50% of patients in the GLORIA trial expansion arm achieving a complete or near-complete response.
The poster with the most recent data is available on the TME Pharma website.