PHILADELPHIA, PA — Imvax Inc. is preparing a roughly 375-patient Phase 3 trial of its experimental glioblastoma therapy IGV-001 after a prespecified Phase 2b subgroup analysis showed longer median survival in a high-risk patient population, though the survival comparison had a P value of 0.0808.
The planned study will focus on patients with newly diagnosed glioblastoma whose tumors have an unmethylated MGMT promoter, or uMGMT. Imvax estimates that this group represents about 55% to 60% of newly diagnosed glioblastoma patients.
In the 48-patient uMGMT subgroup, median overall survival was 14.8 months for patients receiving IGV-001 compared with 10.6 months for the placebo group, a difference of 4.2 months, or 40%. The hazard ratio was 0.60, with a P value of 0.0808.
Imvax characterized the result as clinically meaningful. The company also reported delayed deterioration in Karnofsky Performance Status, favorable quality-of-life measures, fewer severe toxicities and a lower burden of serious adverse events among IGV-001 patients compared with placebo.
“The magnitude and consistency of the treatment effect observed across survival, functional, and patient-reported outcome measures support continued investigation of IGV-001 in the uMGMT patient population,” J. Bradley Elder, director of neurosurgical oncology and a professor at The Ohio State University Wexner Medical Center, stated. Elder was the highest-enrolling investigator in the Phase 2b trial.
Imvax met with the U.S. Food and Drug Administration earlier this year to discuss the Phase 2b results and a potential regulatory pathway. A subsequent July meeting resulted in alignment on key elements of the proposed randomized, open-label Phase 3 trial, according to the company.
The study is expected to enroll about 375 U.S. patients with uMGMT newly diagnosed glioblastoma. Overall survival would serve as the primary endpoint, with an interim analysis planned after a specified number of patient deaths.
Imvax plans to incorporate the FDA feedback into a final proposed protocol and submit it to the agency in the coming months. The company is seeking financing to support a planned 2027 trial launch.
The Phase 2b trial enrolled 99 newly diagnosed glioblastoma patients across 19 U.S. sites and randomized them 2:1 to IGV-001 or placebo. Across the full trial population, median overall survival was 20.3 months in the treatment arm compared with 14 months for placebo, a 6.3-month difference.
Median follow-up for the trial was 22 months. Imvax reported no drug-related serious adverse events in the treatment arm and characterized the safety profile as consistent with an earlier 33-patient Phase 1b study.
The Phase 2b findings are scheduled for a rapid oral and poster presentation at the Society for Neuro-Oncology annual meeting, running Nov. 12 through Nov. 15 at the Pennsylvania Convention Center in Philadelphia. Elder will present abstract CTIM-05.
IGV-001 is an investigational autologous biologic-device combination product derived from Imvax’s Goldspire immuno-oncology platform. It is intended to generate a patient-specific immune response against multiple tumor antigens.
The FDA has granted IGV-001 Fast Track and Orphan Drug designations for newly diagnosed glioblastoma. The treatment has not been approved by the FDA or any other regulatory authority.
About 14,000 people are diagnosed with glioblastoma annually in the U.S., according to Imvax. Standard treatment generally involves surgery followed by radiation and temozolomide, but patients with unmethylated MGMT tumors typically derive limited benefit from temozolomide and currently have no approved therapy specifically for uMGMT disease.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.