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Abstract
Introduction. Diffuse high-grade gliomas, particularly glioblastoma (GBM), are characterized by treatment resistance, which is partly due to the tumor's ability to evade the immune response. Immunotherapy, particularly dendritic cell vaccines (DCVs), represents a promising approach to overcome this resistance by activating a specific anti-tumor immune response.
Aim. To evaluate the efficacy and safety of the dendritic cell vaccine CaTeVac in combination with standard systemic therapy for patients with newly diagnosed and recurrent glioblastoma.
Materials and Methods. This interim analysis of the ongoing single-center, phase II DENDRON-2 study was conducted in two out of six cohorts. Cohort GBM1l (n=23) comprised patients with newly diagnosed GBM who received CaTeVac alongside primary therapy. Cohort GBM2+s (n=22) included patients with recurrent GBM on the second or subsequent lines of therapy, who had achieved disease stabilization after 2-4 treatment cycles and were then administered CaTeVac. The primary endpoint was 6-month progression-free survival (PFS).
Results. In the GBM1l cohort, the 6-month PFS rate was 100%, the 1-year PFS rate was 64.4%; median PFS was 14.3 months (95% CI 11.2–NA); median OS was 28.5 months (95% CI 17.8–NA). In the GBM2+s cohort, the 6-month PFS rate was 90.5%, the 1-year PFS rate was 65%; median PFS was 17.7 months (95% CI 11.8–NA); median OS was 36.7 months (95% CI 21.2–NA). The addition of the CaTeVac vaccine did not increase treatment-related toxicity compared to standard therapy alone.
Conclusion. The combination of the CaTeVac vaccine with standard therapy demonstrates high efficacy in patients with both newly diagnosed and recurrent GBM, exceeding historical treatment data, with a comparable safety profile. To confirm the role of the vaccine, randomized controlled trials are necessary.
References
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