TME Pharma N.V. announced publication of the submitted abstract by conference organizers of positive interim data from the GLORIA Phase 1/2 clinical trial expansion arm with NOX-A12 combined with radiotherapy and bevacizumab (biosimilar of Avastin®) in first-line MGMT unmethylated brain cancer (glioblastoma) patients. The interim data from the published abstract show that five out of six patients (83.3%) achieved radiographic partial responses, which remained durable at a median follow-up of 5.6 months (range 3.6 to 9.3 months). Patients with MGMT-unmethylated brain tumors (refractory to chemotherapy) are particularly challenging and respond only rarely to standard of care.

The GLORIA data compare favorably to a matched historical reference cohort of 20 glioblastoma patients treated with standard of care, where only 10% of patients achieved partial responses. In the GLORIA Phase 1/2 brain cancer trial in combination with bevacizumab, the mean best response in tumor size reduction was -65.9% (-13.3% to -99.9%) for sum of target lesion and -92.1% (-76.2% to -100%) for sum of non-target lesions (NTL). In all three patients with NTL, at least one lesion disappeared.

Advanced MRI parameters showed reduced blood flow to targeted tumor lesions vs. baseline in all patients, consistent with the anticipated mechanism of action of preventing tumor blood vessel regrowth. Importantly, the neurological function of patients receiving NOX-A12 + RT + bevacizumab remained stable during follow-up as assessed by a scale adapted to patients with brain tumors, the Neurologic Assessment in Neuro-Oncology (NANO) scale.