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

Kiavasch Mohammad Nejad Farid1, Florian Kocher2, Tobias Arnold3

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Tabelecleucel (tab-cel) therapy shows efficacy and low toxicity for relapsed or refractory Epstein-Barr virus-associated lymphoproliferative disorders in transplant patients. Real-world data supports its integration into clinical management.

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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.