About EBV+ PTLD
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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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:
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
Allogeneic: expanded from third-party donors
Not genetically modified
Patient HLA compatible
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
ALLELE Study Design
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
*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
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
*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
84% of EBVALLO responders were alive at 1 year in ALLELE2
All patients
(95% CI: 43.7–74.5)
Responders (n=22)
(95% CI: 58.9–94.7)
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
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
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)