TME Pharma N.V. announced the presentation of updated interim results from the GLORIA Phase 1/2 clinical trial expansion arm with NOX-A12 combined with radiotherapy and bevacizumab (biosimilar Avastin®) in chemotherapy-refractory (MGMT unmethylated) brain cancer (glioblastoma) in a poster presentation at the Society for Neuro-Oncology (SNO) Annual Meeting, held in Tampa, Florida, US from November 16 – 20, 2022. The company additionally disclosed newer data from the expansion arm that became available after the presentation submission cut-off date, as well as results from the completed dose-escalation part of the same clinical trial. The poster as well as the most recent data highlight the following key points: 100% of target lesions treated with the triple combination of NOX-A12, radiotherapy and bevacizumab were reduced by more than 50%.

5 of 6 patients (83%) achieved durable partial responses (PR) by mRANO criteria1, which takes into account radiographic response as well as other factors such as clinical condition of the patient. One patient experienced progressive disease (PD) due to distant failure while target lesion control was maintained. 2 of 6 patients achieved almost complete tumor size reduction (>99%) where contrast enhancing lesions were detectable but too small to be measured.

The data for the second patient achieving >99% decrease in tumor size was obtained shortly after the data cut-off for the poster and will be presented in the webinar on November 22, 2022. The mean best sum of perpendicular diameters (SPD) of the tumor response was -74.9% (-53.8% to -99.9%) for target lesion sums. The triple combination was well tolerated and safe. No dose-limiting toxicities were observed.