On October 20, 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 another patient has reached the 18-month survival mark after start of therapy increasing overall survival at 18 months (OS-18) to 67% in the GLORIA expansion arm for newly diagnosed glioblastoma patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy (Press release, TME Pharma, OCT 20, 2023, View Source [SID1234636199]).
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This announcement provides an update to a recent disclosure by the company (October 10, 2023) at time of which the last patient had not yet passed the 18-month survival mark. The percentage of patients alive 18 months after the start of their therapy has thus increased from 50% to 67% (4 of 6 patients). Thus, the survival rate at 18 months of patients treated with NOX-A12 + bevacizumab (anti-VEGF) + radiotherapy outperforms by 13-fold the 18-month survival of 5% observed in the matched group of reference patients receiving standard of care1.
Median overall survival also continues to improve further and has already exceeded 18 months as the remaining patients in the GLORIA clinical trial 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.
"We have reached a decisive moment in the development of our lead asset NOX-A12 in aggressive adult brain cancer with the achievement of an unprecedented 18-month survival rate of 67 percent in patients with chemotherapy refractory tumors not amenable to complete surgical resection," said Aram Mangasarian, CEO of TME Pharma. "We have been steadily building this compelling body of clinical evidence month by month to the point where NOX-A12-based therapies now have the potential to be the best available treatment for glioblastoma patients. It has been highly encouraging to see the data reach meaningful maturity enabling us to have a constructive discussion with regulators before the end of the year on the next steps in development and potential for access to an expedited regulatory pathway for approval of NOX-A12. We target having an IND in place and access to an expedited pathway by the end of Q1 2024, which we expect will attract significant interest from investors and potential partners."