Real-world experience with tabelecleucel within and beyond the approval label

Area of Science:

• Immunology
• Oncology
• Transplantation Medicine

Background:

• Tabelecleucel (tab-cel) is an approved therapy for relapsed/refractory (R/R) EBV-associated post-transplant lymphoproliferative disorder (PTLD).
• Real-world evidence on tab-cel usage and outcomes is limited.

Purpose of the Study:

• To investigate the real-world usage and outcomes of tab-cel in Germany, Austria, and Switzerland.
• To analyze baseline characteristics and survival parameters in patients treated with tab-cel.

Main Methods:

• Retrospective analysis of eleven patients with EBV-positive PTLD or other EBV-associated lymphoproliferative disorders (LPD).
• Patients received a median of two cycles of tab-cel across nine academic centers.
• Data collected included baseline characteristics, treatment cycles, response, survival, and adverse events.

Main Results:

• 6/11 patients (55%) remained alive after a median follow-up of 15.1 months.
• 7/11 patients (64%) achieved an objective response, with best response at a median of 31 days.
• Median overall survival was 13.4 months, influenced by salvage treatments; immunotherapy-related adverse events were rare.

Conclusions:

• Tabelecleucel demonstrates efficacy and low toxicity in R/R PTLD/LPD within an immunocompromised/transplanted patient cohort.
• Real-world data supports the integration of tab-cel into the management of R/R PTLD.
• Further studies can elucidate optimal treatment strategies incorporating tab-cel.