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Imvax reported top-line results from its randomized double-blind, placebo-controlled Phase 2b trial of IGV-001 in 99 patients with newly diagnosed (ndGBM). IGV-001 demonstrated a median overall survival (mOS) of 20.3 months, a 6.3 month improvement over placebo (14.0 months). Median follow-up was 22 months. The trial did not meet statistical significance for the endpoint of progression-free survival, but showed a very favorable profile with no drug-related serious adverse events.
The study used 2:1 randomization across 19 U.S. sites, one of which was initiated by our Chief Scientific Advisor, Dr. Steven Brem! About 48 hours post-tumor resection, patients received biodiffusion chambers containing either personalized whole tumor-derived cell with an antisense oligonucleotide (IMV-001) or inactive solution (placebo); chambers were removed 48 hours later. All patients then received standard-of-care chemoradiation and maintenance temozolomide.
IGV-001 has Fast Track and Orphan Drug designations, and Imvax plans to meet with the FDA in the coming months to discuss the regulatory pathway. Given these significant results and the profound lack of promising options for GBM, we hope to see widescale patient access to this therapy in the near future.