Vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy in newly diagnosed glioblastoma - Interim analysis of the GlioVax trial
Marion Rapp (Düsseldorf), Angeliki Datsi (Düsseldorf), Jörg Felsberg (Düsseldorf), Guido Reifenberger (Düsseldorf), Bernd Turowski (Düsseldorf), Oliver Grauer (Münster), Heinz Wiendl (Münster), Andreas Hippe (Düsseldorf), Pablo Verde (Düsseldorf), Uwe Schlegel (Zürich), Korinna Seeliger (Bochum), Thomas Kowalski (Bochum), Kirsten Schmieder (Düsseldorf), Kathleen Jetschke (Bochum), Dorothea Miller (Bochum), Martin Scholz (Duisburg), Su-Zin Jung (Duisburg), Martin Wettig (Duisburg), Roman Arend (Duisburg), Michael Stoffel (Krefeld), Knut Send (Krefeld), Walter Stummer (Münster), Markus Holling (Münster), Nils Warneke (Münster), Benjamin Brokinkel (Münster), Nora Bünger (Münster), Konstantinos Gousias (Lünen), Rachit Agrawal (Lünen), Rüdiger V. Sorg (Düsseldorf), Michael Sabel (Düsseldorf)
In the phase II GlioVax trial, patients with newly diagnosed, IDH wildtype glioblastoma are treated either with autologous dendritic cell vaccination as add-on to standard radiochemotherapy after fluorescence-guided surgery or with standard radiochemotherapy alone. Here, we present data from the first interim analysis.
In the multicentric, prospective, randomized GlioVax trial, 136 patients are randomized 1:1 into the vaccination or control arms, stratified for MGMT promotor methylation. Primary endpoint is overall survival (OS), secondary endpoints are progression free survival (PFS), OS and PFS rates at 6,12 and 24 months after surgery as well as safety, quality of life and neurological performance. The follow-up is 2 years. The study design is illustrated in Figure 1.
This interim analysis presents data from 96 patients (n=47 control group, n=49 vaccination group, 61% male, 35% female, mean age 61.5 years, range: 27-82 years). Median OS in the vaccination and control groups is 1.7 years [1.4, - ] and 1.3 years [1.2 - 1.9], respectively (p=0.14), with a median study length of 1.6 and 1.5 years (Figure 2). There was no difference in the frequency and severity of adverse events between the two groups.
Based on the interim analysis, dendritic cell vaccination of GBM patients is feasible and overall well tolerated. Moreover, there is a trend for increased OS, which needs to be substantiated in the final analysis. Meanwhile, recruitment was concluded. Final data analysis is expected for mid-2027.