TME Pharma NV has announced a positive clinical update on best response to therapy, reporting one patient achieving a complete response in the GLORIA expansion cohort evaluating NOX-A12, TME Pharma’s CXCL12 inhibitor, combined with standard care radiotherapy and an anti-VEGF, bevacizumab, in glioblastoma first line.
TME Pharma is a biotechnology company focused on developing new therapeutics for cancer treatment by targeting the tumor microenvironment (TME).
One patient (out of six) in the expansion arm with the previous best response of 89.9% tumor shrinkage had achieved a complete response, meaning the tumor disappeared completely and was no longer detectable by MRI. Complete response occurred in addition to two patients with near-complete (>99%) reduction in tumor size, resulting in 50% of patients in the expansion arm of the GLORIA trial achieving complete or near-complete response.
“We are pleased to report this very positive update from our expanded GLORIA clinical trial evaluating our key asset NOX-A12 in combination with radiotherapy and bevacizumab in glioblastoma,” said Aram Mangasarian, CEO of TME Pharma.
“It was heartening to see one patient not achieve a detectable tumor and two patients coming very close to complete response, achieving a tumor size reduction of over 99%. This complete response took approximately 12 months of therapy to achieve, underscoring the importance of mature data to fully evaluate the power of NOX-A12-based therapies. Together with the promising pictures emerging from our survival data, it is increasingly clear that NOX-A12 used in combination with this treatment can provide clinically meaningful benefits over standard care for brain cancer patients, who currently have limited therapeutic options.”
The most recently reported survival data from the GLORIA expansion arm showed that after 15 months of the study (median), five out of six patients were still alive. As long as treatment or follow-up for these patients is ongoing, the average overall survival (mOS) will continue to increase. For reference, the expected overall median survival for patients under current standards of care with chemotherapy-refractory tumors (non-methylated MGMT) and whose tumors remain detectable after surgical intervention is approximately 10 months.
In November 2022, TME Pharma announced interim results of its GLORIA expansion arm showing 100% target lesions treated with the triple combination of NOX-A12, radiotherapy, and bevacizumab reduced by more than 50% as measured by MRI.
The results also showed that five of the six patients achieved long-lasting partial response (PR) by mRANO criteria, which considered radiographic response as well as other factors such as the patient’s clinical condition. One patient developed progressive disease (PD) due to distant failure while control of the target lesion was maintained. Also, triple combinations are well tolerated and safe. No dose-limiting toxicity was observed.