About EBVALLO: Mechanism of Action, Manufacturing, Treatment Schedule, Preparation & Administration

EBVALLO IN A NUTSHELL

EBVALLO is the first and only on-demand allogeneic T-cell immunotherapy approved for the treatment of relapsed or refractory EBV+ PTLD³

Anti-EBV-specific cytotoxic T-cells

Allogeneic: expanded from third-party donors

Not genetically
modified

Patient HLA
compatible

Stocked in an on-demand biobank

EBVALLO selectively eliminates EBV-transformed tumour cells while sparing healthy cells³

EBV+, Epstein-Barr virus positive; HLA, human leukocyte antigen; PTLD, post-transplant lymphoproliferative disease

MODE OF ACTION

This is a simplified example of the mechanism of action

MANUFACTURING & LOGISTICS

EBVALLO is manufactured from healthy EBV+ donors with diverse HLA profiles to produce expanded CTL lots that are characterised by EBV-specific cytotoxicity and HLA restriction²

EBVALLO is specifically selected for each patient, based on the patient’s disease HLA profile^2,3

ClinicalTrials.gov Identifier: NCT03394365
APC, antigen-presenting cell; CTL, cytotoxic T lymphocyte; EBV+, Epstein-Barr virus positive; HLA, human leukocyte antigen; PBMC, peripheral blood mononuclear cell; PTLD, post-transplant lymphoproliferative disease

TREATMENT SCHEDULE & ALGORITHM

Each cycle of EBVALLO lasts approximately 35 days – the number of EBVALLO cycles required depends on patient’s response³

The number of cycles of EBVALLO is determined by response to treatment³

*CR at the end of a cycle followed by PR or other response at any subsequent cycle is considered PD³.

D, day; CR, complete response; IR, indeterminate response; PD, progressive disease; PR, partial response; SD, stable disease.

PREPARATION & ADMINISTRATION

References

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

1. EBVALLO EPAR.
2. Mahadeo KM, et al. Poster 4658. Presented at ASH Annual Meeting and Exposition; Dec. 10–13, 2022; New Orleans, Louisiana, USA. New and Updated Results from a Multicenter, Open-Label, Global Phase 3 Study of Tabelecleucel (Tab-cel) for Epstein–Barr Virus-Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) Following Allogeneic Hematopoietic Cell (HCT) or Solid Organ Transplant (SOT) after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE).
3. EBVALLO Summary of Product Characteristics. December 2022.
4. Dierickx D, et al. Post-Transplantation Lymphoproliferative Disorders in Adults. N Engl J Med. 2018;378:549–562.
5. Nijland ML, et al. Epstein-Barr virus-positive posttransplant lymphoproliferative disease after solid organ transplantation: pathogenesis, clinical
manifestations, diagnosis, and management. Transplant Direct. 2016;2(1):e48.
6. Sanz J, et al. Abstract 1454. Presented at: ASH Annual Meeting and Exposition; December 11–14, 2021; Atlanta. Clinical Outcomes of Patients with Epstein–Barr Virus-Driven Post-Transplant Lymphoproliferative Disease Following Hematopoietic Stem Cell Transplantation Who Fail Rituximab:A Multinational, Retrospective Chart Review Study. Blood. 2021;138(Suppl 1):1454.
7. Dharnidharka V, et al. Abstract 2528. Presented at: ASH Annual Meeting and Exposition; December 11–14, 2021; Atlanta. Clinical Outcomes of Solid Organ Transplant Patients with Epstein-Barr Virus-Driven (EBV) Post-Transplant Lymphoproliferative Disorder (PTLD) Who Fail Rituximab Plus Chemotherapy: A Multinational, Retrospective Chart Review Study. Blood. 2021;138(Suppl 1):2528.
8. NCT03394365. Available at: https://clinicaltrials.gov/ct2/show/NCT03394365.
9. Mahadeo KM, et al. Abstract 4658. Presented at ASH Annual Meeting and Exposition; Dec. 10–13, 2022; New Orleans, Louisiana, USA. New and Updated Results from a Multicenter, Open-Label, Global Phase 3 Study of Tabelecleucel (Tab-cel) for Epstein–Barr Virus-Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) Following Allogeneic Hematopoietic Cell (HCT) or Solid Organ Transplant (SOT) after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE). Blood. 2022;140(Suppl 1):10374–10376.
10. Choquet S, et al. Abstract 258. Presented at ICML; June 18–22, 2021; Virtual Congress. Epstein-Barr virus-driven diseases: a multinational, multicohort, open-label phase 2 study to assess the efficacy and safety of tabelecleucel using an adaptive study design.

This is an international website for EBVALLO®. IMPORTANT: the information on this website is based on the European Summary of Product Characteristics. Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.