Real-world experience with Tabelecleucel within and beyond the approval label.

Le résumé fourni par la source

Tabelecleucel (tab-cel) is an allogeneic Epstein-Barr-virus (EBV)-specific T-cell therapy approved in the European Union for relapsed or refractory (R/R) EBV-associated post-transplant lymphoproliferative disorder (PTLD) after rituximab or immunochemotherapy failure. Despite its promise as the first approved option, real-world evidence remains limited. The aim of this study was to investigate the scope of usage and outcomes of tab-cel treatment in the real-world setting in Germany, Austria and Switzerland. Eleven patients with EBV-positive PTLD or other EBV-associated lymphoproliferative disorders (LPD) from nine academic centers were included for a detailed analysis of baseline characteristics and survival parameters. Eight patients with PTLD (six after solid organ transplantation and two after allogeneic hematopoietic cell transplantation) and three with EBV-associated LPDs were treated with a median of two cycles tab-cel (range 1-3). After a median follow-up of 15.1 months, 6/11 patients (55%) remain alive. Initially, 7/11 patients (64%) achieved an objective response and best response occurred after a median of 31 days after the first tab-cel infusion (i. e. end of cycle one). Relapse and progression after tab-cel occurred in 7/11 patients (64%). The estimated median overall survival was 13.4 months (CI 4.4-14.7) due to successful subsequent salvage treatments. Immunotherapy-related adverse events were rare. Tab-cel shows efficacy and low toxicity in R/R PTLD/LPD in the vulnerable cohort of immunodeficient/transplanted patients. This real-world data helps elucidating optimal integration of tab-cel in the management of R/R PTLD.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.