Results of brexucabtagene-autoleucel for patients with relapsed/refractory Mantle Cell Lymphoma in the routine setting in Germany and Switzerland

Mantle Cell Lymphoma (MCL) is an incurable B-cell neoplasm, representing 6–8% of newly diagnosed B-cell lymphomas [1]. Brexucabtagene-autoleucel (brexu-cel, Tecartus®) is a CD19-targeting chimeric antigen receptor (CAR) T-cell therapy approved in Europe for treatment of relapsed/refractory (r/r) MCL after two prior lines of therapy, including a Bruton’s tyrosine kinase inhibitor (BTKi) [2]. Approval was based on a small population of 68 patients in the ZUMA-2 trial [2]. Therefore, data on toxicities and long-term outcomes in a real-world setting are of great value to confirm the potential and show limitations of brexu-cel.

With this intent, we performed a retrospective real-world analysis of brexu-cel as standard-of-care (SOC) treatment for r/r MCL in Germany and Switzerland.

Patients and methods

Data were extracted from the European Mantle Cell Lymphoma Registry (EMCL-R) and the German Registry for Stem cell Transplantation (Deutsches Register für Stammzelltransplantation und Zelltherapie, DRST). Written informed consent in accordance with the European data protection regulations and the Declaration of Helsinki was obtained.

Eligibility included r/r MCL, age ≥18 years and treatment prior to Oct. 2023 within the early access program or as SOC. Last follow-up was October 31st, 2024. Median follow-up for the entire population was 17 months.

113 patients were included from 18 German and one Swiss center. Baseline characteristics are displayed in S1 and 2. Median time from diagnosis to CAR-T therapy was 63 months, prior treatment lines included autologous and allogeneic hematopoietic stem cell transplantation (allo-HSCT) (63% and 10%, respectively). Seventy-three patients (65%) had been refractory to the last treatment prior to brexu-cel indication or experienced relapse within 12 months after initiation (POD12). Twenty-six patients (23%) did not fulfill the ZUMA-2 eligibility criteria due to history of allo-HSCT, ECOG > 1 or > 5 prior lines of therapy. TP53 mutation was present in 27%, Ki-67 > 30% in 79% and blastoid variant in 33% of patients. Bridging was administered to 89% of patients (S3 and 4).

Out of 85 patients with response data available, 61% showed complete remission (CR), 27% partial remission (PR) and 12% stable/progressive disease (SD/PD). Median duration of response was 31 months (S5 and 6).

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