About EBV+ PTLD

  • Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) is a rare, acute and potentially life-threatening group of lymphoid disorders that arise after transplantation4,5:

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    EBV disease

Unmet need:

The poor patient prognosis associated with EBV+ PTLD upon rituximab-based treatment failure calls for an urgent intervention6,7.The Median OS post rituximab +/- chemotherapy failure is:

 

0.7 months post HCT 6
4.1 months post SOT 7

 

DNA, deoxyribonucleic acid; EBV+, Epstein-Barr virus positive; PTLD, post-transplant lymphoproliferative disease; HCT, haematopoietic cell transplantation; OS, overall survival; SOT, solid organ transplantation.

 

ABOUT EBVALLO

EBVALLO is the first and only on-demand allogeneic T-cell immunotherapy approved for the treatment of relapsed or refractory EBV+ PTLD.3

Anti-EBV specific cytotoxic T-cells

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Anti-EBV specific cytotoxic T-cells

Allogeneic: expanded from third-party donors

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Allogeneic: expanded from third-party donors

Not genetically modified​

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Not genetically modified​

Patient HLA compatible

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Patient HLA compatible

Stocked in an on-demand bio-bank

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Stocked in an on-demand bio-bank

EBV+, Epstein-Barr virus positive; HLA, human leukocyte antigen

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

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EBV infected

ALLELE Study Design

A multicentre, open-label, pivotal study of EBVALLO after failure of rituximab ± CT in patients with EBV+ PTLD following HCT or SOT1,8

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study design

*Treatment ends with any of the following: maximal response achieved, unacceptable toxicity, initiation of non-protocol therapy, failure of up to 4 lots with different HLA restrictions (HCT) or 2 lots with different HLA restrictions (SOT). Please refer to treatment algorithm for more details. †Evaluated by independent review (IORA).
CT, chemotherapy; DOR, duration of response; EBV+, Epstein-Barr virus positive; ECOG, Eastern Cooperative Oncology Group; HCT, haematopoietic cell transplantation; HLA, human leukocyte antigens; IV, intravenous; ORR, objective response rate; OS, overall survival; PTLD, post-transplant lymphoproliferative disease; SOT, solid organ transplantation; TTR, time to response.

EBVALLO EFFICACY

 

Objective Response Rate 

 

51% of patients responded to EBVALLO with rates consistent across SOT and HCT cohorts1

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ALLELE Response rate

Data cut-off: November 5th, 2021.

CR, complete response; DOR, duration of response; EBV+, Epstein-Barr virus positive; HCT, haematopoietic cell transplantation; ORR, objective response rate; OS, overall survival; PR, partial response; PTLD, post-transplant lymphoproliferative disease; SOT, solid organ transplantation; TTR, time to response.

 

In the ALLELE study, patients responded rapidly and durably to EBVALLO1,2 

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Median time to response

*Independent oncologic response adjudication (IORA)-assessed response.
CI, confidence interval; NE, not evaluable


Overall Survival 

ALLELE: Patients have a median OS of 18.4 months in the overall population (HCT and SOT)2

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OS result
 

84% of ​​EBVALLO responders were alive at 1 year in ALLELE2 
 

61%

All patients
(95% CI: 43.7–74.5)

84%

Responders (n=22)
(95% CI: 58.9–94.7)

35%

Non-responders (n=21)
(95% CI: 14.6–56.1)

 

 

HCT: Haematopoietic cell transplant; OS: overall survival; SOT: solid organ transplant; CR: complete response; PR: partial response; SD: stable disease;  ALLELE Study: A multicentre, open-label, pivotal study of EBVALLO after failure of rituximab ± CT in patients with EBV+ PTLD following HCT or SOT.
 

EBVALLO SAFETY

In the ALLELE study, very few identified and potential risks associated with cellular therapies were reported2,9

The safety profile was favourable, with very few treatment-related adverse events2

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Safety ALLELE

​​​​ 

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Safety

Data cut-off: November 5th, 2021.

HCT, haematopoietic cell transplantation; SOT, solid organ transplantation; TESAE, treatment-emergent serious adverse event; EBV+, Epstein-Barr virus positive; GvHD, graft-vs-host disease; ICANS, immune effector cell-associated neurotoxicity syndrome; PTLD, post-transplant lymphoproliferative disease; TFR, tumour flare reaction.

You can ORDER EBVALLO

 

You can order EBVALLO trough the Go Cell Therapy platform (www.go-cell-therapy.com)

 

Go Cell Therapy

Healthcare Professionals

This is an international website for EBVALLO® dedicated to healthcare professionals.

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.

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Non Healthcare Professionals

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