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On December 2, 2025, Imvax, Inc. announced top-line results from a Phase 2b clinical trial of IGV-001, an investigational autologous biologic-device combination product, in 99 adults with newly diagnosed glioblastoma (ndGBM). GBM is the most common and aggressive malignant brain tumor, with an average life expectancy of between 12 to 15 months and a five-year survival rate under six percent. The last change to the standard of care for ndGBM, often referred to as the Stupp protocol, was reported in 2005.
The Imvax Phase 2b study was a double-blind, placebo-controlled trial conducted at 19 sites in the United States. Patients in the trial were randomized 2:1 to receive either IGV-001 or placebo. Approximately 48 hours after surgical resection of the patient’s malignant tumor, participants in the IGV-001 arm were implanted with biodiffusion chambers containing a combination of personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001); in the placebo arm, the chambers contained an inactive solution only. In both arms, the biodiffusion chambers were explanted approximately 48 hours later, and after six weeks all patients were treated with standard of care (adjuvant concomitant radiotherapy and temozolomide followed by maintenance temozolomide).
In this trial, median overall survival was 20.3 months in the IGV-001 arm and 14.0 months in the placebo arm, a difference of 6.3 months, or 45%. The median follow-up for patients in the study was 22 months. Imvax reported no drug-related serious adverse events in the IGV-001 arm and described the safety profile as both favorable and consistent with an earlier Phase 1b study of the product. Across the two clinical studies, approximately 100 patients with ndGBM have received IGV-001. The Phase 2b trial did not reach statistical significance on the primary endpoint of progression-free survival.
The United States Food and Drug Administration (FDA) has granted both Orphan Drug and Fast Track designations to IGV-001 for the treatment of ndGBM. Imvax has notified the FDA of its intent to request a meeting to discuss the regulatory pathway based on these Phase 2b data.
For patients and families facing an ndGBM diagnosis, these results may be of interest given the limited progress in improving survival outcomes over the past 2 decades. ABTA President and Chief Executive Officer, Kelly Sitkin, noted in the announcement that glioblastoma remains a “heartbreaking diagnosis” with few treatment options, and that patients and families are often seeking the possibility of more time with their loved ones.
Each year in the United States, about 14,000 people are diagnosed with glioblastoma. As new investigational approaches like IGV-001 are studied, many in the brain tumor community closely follow clinical trial results, seeking trustworthy information on how new therapies are being evaluated for safety and potential impact on outcomes. The ABTA will continue to monitor developments and share updates as more information emerges on this potential treatment option.
