TME Pharma Prepares IND Filing for Olaptesed Pegol in GBM Following FDA Meeting
The FDA completed an advice meeting with the manufacturer of olaptesed pegol in anticipation of the filing of an investigational new drug application in Q1 of 2024.
Tumor in brain: © peterschreiber.media - stock.adobe.com
- The company that manufactures olaptesed pegol (NOX-A12) met with the FDA to discuss regulatory requirements and received feedback.
- They believe strong data from the GLORIA trial (NCT04121455) in glioblastoma (GBM) and a defined regulatory path will attract potential partners.
- Final trial design will be shared after FDA assessment.
TME Pharma, manufacturer of olaptesed pegol, (NOX-A12), a CXCL12 inhibitor used for the treatment of glioblastoma (GBM), has completed a pre-investigational new drug (IND) advice meeting with the FDA and plans to file its IND and expedited regulatory pathway request by the end of Q1 2024.1
“The informative discussion with the FDA allows our team to prepare an IND application that fits with the requirements of the [United States] regulator in areas where there has been recent evolution in recommendations by the FDA’s Oncology Center of Excellence, such as the selection of the appropriate therapeutic dose of new oncology drugs2," said Aram Mangasarian, chief executive officer of TME Pharma, in a press release. “While the company plans to provide further updates on the status of applications during the ongoing discussions, the final trial design will be shared once the FDA has completed its assessment. We believe that the combination of a defined regulatory path and the mature data from the GLORIA brain cancer trial will, together, form an attractive package for potential partners.”
Olaptesed pegol combined with radiation therapy is being investigated in the phase 1/2 GLORIA trial (NCT04121455) in patients with newly diagnosed GBM who have unmethylated MGMT- promoted status.
Updated findings from the study were presented at the 2023 Society for Neuro-Oncology Annual Meeting, as well as after a 19-month follow-up analysis. Olaptesed pegol combined with bevacizumab (Avastin) and radiotherapy demonstrated a 67% overall survival (OS) at 18 months compared with standard-of-care (SOC) radiotherapy that achieved 5% survival and a median OS of 10.5 months.2 At a median follow-up of 19 months, the median OS has passed 19 months.3 Further, the median progression-free survival (PFS) was 9 months with olaptesed pegol, bevacizumab, and radiotherapy compared with 4 months with SOC radiotherapy.2
About the GLORIA Study
GLORIA is a phase 1/2 dose-escalation study of olaptesed pegol plus radiation in patients with inoperable or partially resected first-line GBM who are unmethylated MGMT promoters. The study also has a 3-arm expansion group with patients with fully resected GBM and is investigating the olaptesed pegol/radiation combination with bevacizumab or pembrolizumab (Keytruda).4
The study’s primary end point is safety. The secondary end points include PFS at 6 months, median PFS, changes in tumor vascularization, plasma concentration of olaptesed pegol, quality- of- life, and neurologic function.
Patients are eligible to participate if they have newly diagnosed, histologically confirmed, supratentorial WHO grade IV GBM and unmethylated promoter status. Patients must also have a maximum ECOG performance status of 2, have an estimated minimum life expectancy of 3 months, and use an effective form of birth control, if applicable. Patients are not eligible to participate if they have a contraindication to MRI contrast agents, a history of other cancers, clinically significant or uncontrolled cardiovascular disease, or uncontrolled concurrent illness.
REFERENCES:
1. TME Pharma announces successful advice meeting with US Food and Drug Administration on NOX-A12 development in brain cancer. News release. TME Pharma. January 9, 2024. Accessed January 10, 2024. http://tinyurl.com/77m6cde8
2. TME Pharma announces additional data from NOX-A12 combination regimen in brain cancer presented at SNO 2023 annual meeting. News release. TME Pharma. November 18, 2023. Accessed January 10, 2024. https://tinyurl.com/aan35bx4
3. TME Pharma announces further improvement in median overall survival at 19 months follow-up in GLORIA brain cancer trial. News release. TME Pharma. December 20, 2023. Accessed December 20, 2023. http://tinyurl.com/yc27wz5m
4. Glioblastoma treatment with irradiation and olaptesed pegol (NOX-A12 in MGMT unmethylated patients (GLORIA). ClinicalTrials.gov. Updated June 22, 2023. Accessed January 10, 2024. https://clinicaltrials.gov/study/NCT04121455
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