TME Pharma N.V. announced that the Data Safety Monitoring Board (DSMB) validated safety data from the initial four weeks of treatment of the first patient enrolled in the GLORIA Phase 1/2 clinical trial expansion arm with NOX A12 combined with radiotherapy and the PD-1 immune checkpoint inhibitor pembrolizumab, and concluded it is appropriate to continue with recruitment of the remaining 5 patients according to the study protocol. GLORIA is a Phase 1/2 dose-escalation study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). The pembrolizumab expansion arm is the second triple-combination arm of the GLORIA clinical trial.
The company also evaluates NOX-A12 combined with radiotherapy and bevacizumab. The company reported promising initial data from the bevacizumab expansion arm on June 23, 2022, and plans to disclose more detailed data from the study at a scientific conference later this year.