TME Pharma N.V. announced that the first patient was enrolled and has received their first week of treatment in the GLORIA Phase 1/2 clinical trial expansion arm with NOX-A12 combined with radiotherapy and the PD-1 immune checkpoint inhibitor pembrolizumab. Once this first patient of this expansion arm has received a four-week treatment of NOX-A12, radiotherapy, and pembrolizumab, the Data Safety Monitoring Board will convene to determine whether it is safe to recruit the remaining five patients into the arm. The expansion arms of the GLORIA trial will each enroll 6 patients with recruitment ongoing at 6 clinical sites.
The clinical sites are now focused on patient recruitment into the second expansion arm with pembrolizumab after having completed recruitment of patients in the expansion arm with bevacizumab. Initial data from the bevacizumab expansion arm exploring the triple combination of NOX-A12, radiotherapy and bevacizumab reported by the company on June 23, 2022, showed reduced tumor size and radiographic partial response (defined as tumor size reduction of more than 50%) in 100% of evaluable patients, with tumor size reductions ranging from -54.7% to -94.7%. Data from the NOX-A12 dose-escalation part of the clinical trial were reported at ASCO 2022 in June and showed that 90% of patients who received NOX-A12 and radiotherapy achieved tumor size reductions and 40% of patients achieved partial response.
TME Pharma aims to disclose more detailed data, including longer follow-up at a scientific conference later this year.