The Autologous CaTeVac Dendritic Cell Vaccine in Patients with Melanoma: Final Results of the DENDRON-01 Study

Abstract

Introduction. Immunotherapy has demonstrated high efficacy in the treatment of melanoma, particularly with the advent of immune checkpoint inhibitors (ICIs). However, systemic immune activation often triggers severe immune-related adverse events (irAEs) that can substantially compromise patient quality of life — a critical concern in adjuvant settings where extended treatment durations are required. In this context, the development of novel, safer, and more targeted immunotherapeutic strategies for melanoma is of paramount importance.

Aim. To evaluate the efficacy and safety of an autologous dendritic cell vaccine (DCV) CaTeVac in melanoma patients, assessing its performance both as adjuvant therapy and standalone treatment in comparison with conventional therapeutic approaches.

Materials and Methods. The study enrolled 154 patients with histologically confirmed melanoma who received DCV treatment between 2009 and 2023. Patients were treated in adjuvant (76 %) or therapeutic (24 %) settings. Adjuvant therapy was administered following complete cytoreduction in stage II–IV patients with high recurrence risk. Therapeutic DCV was reserved for patients with measurable disease who had exhausted standard treatment options. The endpoints included overall survival (OS), progression-free survival (PFS), and the frequency and severity of adverse events, evaluated in comparison with a historical control group.

Results. In the adjuvant setting, administration of the CaTeVac DCV led to a statistically significant improvement in median PFS (15.0 vs. 8.6 months in controls (p < 0.02). The median OS in the CaTeVac cohort remained unreached after more than 10 years of follow-up vs. 52.5 months for controls (p = 0.01). For patients receiving standalone treatment, CaTeVac showed modest but statistically superior PFS versus monochemotherapy (2.5 vs. 2.3 months; p < 0.05), though no significant OS difference was observed (12.4 vs. 11.4 months; p > 0.05). The safety profile of CaTeVac was favorable, with 64 % of treatment cycles being adverse event-free. Fever occurred in 45.1 % of the therapy cycles: grade 1 (40.8 %), 2 (4 %), and 3 (0.3 %). Pain, allergic reactions, local reactions, and laboratory abnormalities each occurred in < 5 % of cycles.

Conclusion. The CaTeVac dendritic cell vaccine demonstrates both clinical efficacy and an excellent safety profile, establishing it as a promising therapeutic option for adjuvant melanoma treatment. In the standalone setting, CaTeVac outperformed conventional monochemotherapy in advanced-stage disease and may serve as a component of personalized immunotherapy in further clinical studies.