TME Pharma N.V. has announced a positive clinical update on the best response to therapy, reporting one patient achieving complete response in the GLORIA expansion arm evaluating NOX-A12, TME Pharma’s CXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab, in first-line glioblastoma.
TME Pharma is a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME).
One patient (out of six) in the expansion arm with a previous best response of 89.9% tumor shrinkage has achieved complete response, meaning the tumor disappeared completely and was no longer detectable by MRI. The complete response comes in addition to two patients with reported near-complete reductions (>99%) in tumor size, leading to 50% of patients in the GLORIA trial expansion arm achieving a complete or near-complete response.
“We are very pleased to report this highly positive update from the expansion arm of our GLORIA clinical trial evaluating our lead asset NOX-A12 in combination with radiotherapy and bevacizumab in glioblastoma,” said Aram Mangasarian, CEO of TME Pharma.
“It is very encouraging to see one patient achieve no detectable tumor and two patients coming extremely close to complete response, achieving a reduction in tumor size of more than 99%. This complete response took about 12 months of therapy to achieve, underlining the importance of mature data to fully evaluate the power of NOX-A12- based therapy. Taken together with the promising picture emerging from our survival data, it is becoming clearer that NOX-A12 used in this treatment combination can provide clinically meaningful benefit over standard of care for brain cancer patients, who currently have such limited therapeutic options.”
The latest survival data reported from the GLORIA expansion arm demonstrated that after 15 months on study (median), five of the six patients are still alive. As long as treatment or follow-up for these patients is ongoing, median overall survival (mOS) will continue to improve. As a reference, the expected median overall survival for patients under current standard of care with chemotherapy refractory tumors (MGMT unmethylated) and whose tumor remains detectable after surgical intervention is approximately 10 months.
In November 2022, TME Pharma announced interim results from the GLORIA expansion arm that demonstrated 100% of target lesions treated with the triple combination of NOX-A12, radiotherapy and bevacizumab were reduced by more than 50% as measured by MRI.
The results also showed five of six patients achieved durable partial responses (PR) by mRANO criteria, which take into account radiographic response as well as other factors such as the clinical condition of the patient. One patient experienced progressive disease (PD) due to distant failure while target lesion control was maintained. Also, the triple combination was well tolerated and safe. No dose-limiting toxicities were observed.