At a median follow-up of 22 months, patients who received IGV-001 achieved a median OS of 20.3 months, which was a 6.3-month increase above the 14.0-month median OS reported in the placebo arm. Notably, the progression-free survival (PFS) benefit with IGV-001 was not statistically significant.
“The data from this trial are highly encouraging and suggest both a clinically meaningful improvement in OS for [patients with] newly diagnosed GBM and a benign safety profile for the therapy,” J. Bradley Elder, MD, director of Neurosurgical Oncology and a professor in the Department of Neurological Surgery at The Ohio State University Wexner Medical Center in Columbus, as well as the highest-enrolling investigator in the phase 2b trial, stated in a news release. “These results represent a potential watershed moment for the treatment of this deadly disease.”
No drug-related serious adverse effects were observed among patients in the IGV-001 arm, and the safety profile of the agent in this trial was favorable and consistent with that reported in a previously conducted phase 1b study (NCT02507583) among 33 patients.
“[Although] treatments for many cancers have come a long way, treatments for GBM have not changed much over the years,” Kelly Sitkin, president and chief executive officer of the American Brain Tumor Association, added in the news release. “It is a heartbreaking diagnosis made even harder by how few treatment options there are. Ultimately, what any patient or family member wants is a chance at more time with loved ones, and new treatments for GBM provide that hope for our community.”
What is the design of the phase 2b study of IGV-001 in patients with GBM?
This randomized, multicenter, double-blind, placebo-controlled trial enrolled 99 patients at least 18 years of age with newly diagnosed GBM across 19 sites in the US.1,2 Patients needed to have a Karnofsky performance score of at least 70 at screening, confirmed measurable disease prior to surgery with at least 1 lesion measuring a total bi-perpendicular product of 4 cm2 in 2 different planes, tumor location in the supratentorial compartment, and adequate bone marrow and organ function at screening.2
Patients were randomly assigned 2:1 to receive IGV-001 or placebo approximately 48 hours after surgical resection of the malignant tumor.1 Patients in the IGV-001 arm underwent implantation with biodiffusion chambers containing a combination of personalized whole tumor-derived cells and an antisense oligonucleotide, which comprise the autologous biologic-device combination. Patients in the placebo arm received biodiffusion chambers that contained an inactive solution. Approximately 48 hours after implantation, all biodiffusion chambers were explanted, and after 6 weeks, all patients received standard-of-care adjuvant concomitant radiotherapy and temozolomide (Temodar) followed by maintenance temozolomide.1,2
PFS served as the primary end point. Secondary end points included OS and safety.
What are the next steps for the development of IGV-001 in glioblastoma?
“Today marks a pivotal moment for both Imvax and for the people affected by newly diagnosed GBM,” John P. Furey, executive chair of the Board of Directors at Imvax—the developer of IGV-001, concluded in the news release.1 “For the past decade, the Imvax team has been dedicated to advancing the development of IGV-001, and the results from this phase 2b study bring us meaningfully closer to achieving that goal. Thanks to the strong support of our investors, Imvax has the resources and expertise to execute on a clear strategy for IGV-001. We are preparing to meet with FDA to discuss the regulatory pathway for IGV-001 and what we believe is a strongly positive risk-benefit profile, especially given the large unmet medical need in newly diagnosed GBM. Finally, we are profoundly grateful to the investigators, patients, and their families for their commitment to this study.”
References
- Imvax announces positive top-line data from phase 2b clinical trial of IGV-001 in newly diagnosed GBM. News release. Imvax, Inc. December 2, 2025. Accessed December 2, 2025. https://www.imvax.com/imvax-announces-positive-top-line-data-from-phase-2b-clinical-trial-of-igv-001-in-newly-diagnosed-gbm/
- A phase 2b clinical study with a combination immunotherapy in newly diagnosed patients with glioblastoma. ClinicalTrials.gov. Updated September 11, 2025. Accessed December 2, 2025. https://clinicaltrials.gov/study/NCT04485949
