Experimental treatment may boost survival in high-risk glioblastoma

The experimental immunotherapy IGV-001 may improve survival outcomes in certain people with an aggressive form of glioma called glioblastoma (GBM), according to a new analysis of data from a Phase 2b clinical trial.

The analysis suggested that IGV-001 improved treatment outcomes in people with glioblastoma whose tumors harbor a specific molecular feature, an unmethylated O6-methylguanine-DNA methyltransferase promoter (uMGMT). According to IGV-001’s developer, Imvax, uMGMT is found in about 55% to 60% of all patients with newly diagnosed GBM. These patients are considered high-risk, as outcomes are generally poor even with state-of-the-art standard treatments.

“Patients with uMGMT [newly-diagnosed] GBM have an urgent need for more effective treatment options,” J. Bradley Elder, MD, an investigator in the trial at The Ohio State University Wexner Medical Center, said in a press release from Imvax.

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Imvax working with FDA on Phase 3 trial plans

Buoyed by these data, Imvax is now planning to launch a Phase 3 clinical trial to further test IGV-001 in GBM. The company said the upcoming study will be open-label — meaning participants will know whether they receive the experimental treatment — and that it will enroll about 375 adults with newly diagnosed uMGMT GBM at sites in the U.S. The study’s main goal will be to evaluate the effect of IGV-001 on survival.

Imvax is currently working with the U.S. Food and Drug Administration (FDA) to finalize plans for the upcoming Phase 3 trial. The company hopes to launch the trial next year.

“With the FDA’s recent feedback, we will be finalizing the protocol for a Phase 3 study focused on patients with uMGMT [newly-diagnosed] GBM, a population that has lacked meaningful treatment innovation in decades and where we saw a clinically meaningful benefit in the Phase 2b study,” said John P. Furey, executive chair of the Imvax board of directors. “We are also actively pursuing financing to support the initiation of this planned Phase 3 trial in 2027.”

Gliomas are nervous system tumors caused by the uncontrolled growth of glia, which are cells that normally protect and support nerve cells. GBM is an especially aggressive form of glioma.

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.

IGV-001 is designed to trigger the immune system to more effectively attack and destroy GBM cells. The therapy uses Imvax’s Goldspire platform, in which pieces of a patient’s own tumor cells are combined with an immune-modulating molecule within an implantable device. The goal is essentially to teach the immune system to identify and attack mutations found in tumor cells but not in healthy cells.

The Phase 2b trial (NCT04485949) tested IGV-001 against a placebo, in addition to standard care, in 99 people with newly diagnosed glioblastoma. Late last year, the company announced results from the overall study: median survival was 20.3 months in the IGV-001 arm and 14 months in the placebo arm, a difference of more than six months, or 45%.

This new analysis focused only on the 48 participants whose tumors harbored the uMGMT feature. Among these patients, median overall survival was 14.8 months with IGV-001 and 10.6 months with placebo, a difference of just over four months, or 40%. IGV-001 also outperformed placebo across various measures of patient function and quality of life.

“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,” Elder said.