Interim phase III analysis of DCVax-L in glioblastoma published in Journal of Translational Medicine.- Northwest Biotherapeutics.

Northwest Biotherapeutics announced the publication of interim blinded survival data from its Phase III clinical trial of DCVax-L (gene therapy) for newly diagnosed Glioblastoma brain cancer. The data were published with 69 co-authors in the peer reviewed Journal of Translational Medicine (JTM). For the total 331 patients the median survival as of this analysis was 23.1 months from surgery. With the standard of care (SOC) (surgery, radiation and chemotherapy), median survival for newly diagnosed Glioblastoma is 15-17 months. For patients with methylated MGMT gene status (131 patients), median survival was 34.7 months from surgery. With standard of care today, median survival for these patients has been reported in the literature as 21.7 months. For patients with unmethylated MGMT gene status (162 patients), the median survival was 19.8 months from surgery. With standard of care today, the median survival for these patients has been reported in the literature as 12.7 months. (MGMT data was not available for 38 patients.)

The top 100 patients (30%) of the total 331 patients in the trial showed particularly extended survival, with median survival of 40.5 months from surgery. This extended survival was not fully explained by known prognostic factors such as age younger than 50 years, methylated MGMT gene status and complete resection (surgical removal) of all of the tumor. Only 8% of these 100 patients had the favorable status on all 3 of these prognostic factors. Overall adverse events with DCVax were comparable to standard therapy alone.