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We have been following Imvax and its personalized glioblastoma (GBM) vaccine, IGV-001, for several years. The early Phase 1b data caught our attention because it included a notable group of long-term survivors, with 5 of 33 patients living at least 60 months. Subsequent studies continued to show encouraging survival signals.
Now, Imvax has announced plans to move IGV-001 into a randomized Phase 3 trial in newly diagnosed GBM patients with an unmethylated MGMT promoter. The study is expected to enroll about 375 patients in the US. In the Phase 2b trial, median overall survival was 20.3 months with IGV-001 compared with 14.0 months with placebo. In the subgroup of 48 patients with unmethylated MGMT promoter, median overall survival was 14.8 months compared with 10.6 months (4.2 month difference, p = 0.0808). Imvax also reported delayed deterioration of Karnofsky Performance Status, favorable quality-of-life measures, fewer severe toxicities and a lower burden of serious adverse events for IGV-001 patients compared with placebo.