Data from Pharmawand - Curated by EPG Health - Date added 20 November 2018
Northwest Biotherapeutics announced that updated blinded interim data from the Phase III trial of DCVax-L for Glioblastoma brain cancer through October 2018 have continued to mature since the prior interim data collection in March 2017, and indicate encouraging patient survival. The Kaplan-Meier (KM) derived interim overall survival (OS) data on the top 100 patients shows 58.4 months median overall survival from surgery (versus 40.4 months in 2017), and does not appear to be fully explained by known prognostic factors. For example, only 8 of the 100 patients had the favorable status on 3 key prognostic factors combined: age older than 50 years, methylated MGMT gene status and full surgical removal of the tumor.
The demographics of the top 100 patients are somewhat more favorable than those of the whole 331-patient "Intent to Treat" (ITT) population in the trial, but are not greatly more favorable. The KM-derived interim data on the overall survival (OS) of the whole ITT population is 23.1 months OS from surgery (versus 23.1 months in 2017) and survival at 1 year is 89.3%, survival at 2 years is 46.4% while survival at 3 years is 28.2%. A key factor affecting survival in patients who receive standard of care treatment for Glioblastoma is whether their MGMT gene is methylated (favorable) or unmethylated (unfavorable) - OS survival from surgery is 35.1 months for methylated versus 19.8 months for unmethylated. A total of 331 patients were enrolled in the trial. The last enrollments were in November 2015. Data were presented at the 23rd Annual Meeting of the Society for Neuro-Oncology.
DCVax is a platform technology that can be applied to multiple cancers. It combines a patient’s own dendritic cells (DC) with cancer related proteins, or antigens, with the aim of inducing immune responses against a patient’s cancer cells.