Imvax Shares Positive Phase 2b Data for IGV-001 Glioblastoma Treatment and Plans FDA Meeting
Imvax's Phase 2b randomized, placebo-controlled trial of IGV-001 in newly diagnosed glioblastoma (ndGBM) enrolled around 100 patients across 20 U.S. sites.
The trial did not meet the primary endpoint of progression-free survival (PFS), showing no statistically significant difference between IGV-001 and placebo groups.
Despite this, IGV-001 demonstrated a notable improvement in median overall survival (mOS) with 20.3 months versus 14.0 months for placebo.
IGV-001 is a personalized immunotherapy using patient-derived tumor cells combined with antisense oligonucleotide in biodiffusion chambers, designed to stimulate a broad immune response against glioblastoma.
The U.S. FDA granted IGV-001 Fast Track designation, reflecting its potential to address serious unmet medical needs in GBM treatment.
Imvax plans to present Phase 2b topline results and take these overall survival data to the FDA for potential regulatory discussion and next steps.
Imvax’s therapy was previously shown to be safe and well-tolerated, with encouraging efficacy signals including improvements in progression-free survival and tumor response in earlier Phase 1b studies.