| Abstract [eng] |
Bispecific antibodies have emerged as a novel therapeutic approach for the treatment of relapsed or refractory B-cell lymphomas, demonstrating promising efficacy in pivotal clinical trials. However, the applicability of these results to routine clinical practice remains uncertain, particularly in heavily pretreated patient populations. Therefore, evaluating the real-world performance of Bispecific Antibodies and comparing these outcomes with existing clinical data is of both scientific and clinical relevance. The aim of this thesis was to evaluate the efficacy and safety of bispecific antibody therapy in a real-world cohort of patients with relapsed or refractory B-cell lymphomas and to compare these outcomes with results reported in pivotal clinical trials and published real-world studies in order to explore potential limitations and implications for their optimal use. To achieve this aim, patient characteristics and treatment history were assessed, treatment efficacy was determined based on response rates and survival outcomes, and the safety profile was evaluated with a focus on adverse events. This retrospective observational analysis included twelve patients with relapsed or refractory B-cell lymphoma, of whom seven were treated with Epcoritamab and five with Glofitamab. Clinical data were collected from medical records, and statistical analysis was primarily descriptive due to the small sample size. The results demonstrated limited efficacy in this real-world cohort. Overall response rates were lower than those reported in clinical trials, with no complete remission observed in patients treated with Epcoritamab and two complete remissions in the Glofitamab subgroup. Median overall survival was approximately eight months after initiation of treatment with bispecific antibodies, reflecting the advanced disease stage and treatment-refractory nature of the cohort. The safety profile was generally consistent with known data, with cytokine release syndrome being the most frequent adverse event. However, a higher incidence of severe adverse events and infections, including sepsis, was observed compared to clinical trial populations. In conclusion, bispecific antibodies represent a clinically relevant treatment option in patients with limited therapeutic alternatives, but their real-world effectiveness appears reduced compared to clinical trial data. These findings highlight the importance of further research to better define optimal treatment timing, sequencing strategies, and patient selection in order to improve outcomes in routine clinical practice. |
