SAFETY OF EBVALLO IN THE ALLELE STUDY
In the ALLELE study, the safety profile was favourable2,8
Very few treatment-related adverse events
were reported2
Very few identified and potential risks associated
with cellular therapies were reported2,8
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.
SAFETY IN POOLED ANALYSIS (PHASE II & PHASE III)
In a pooled analysis with 103 patients, EBVALLO was well tolerated, with most common adverse reactions occuring in less than a third of patients*t3
| ADVERSE REACTIONS | N | % | Grade |
|---|---|---|---|
| TFR | 1 (1%) | 3 | Patient recovered fromTFR |
| GvHD | 5 (4,9%) | 2 grade 1 1 grade 2 1 grade 3 1 grade 4 | No fatal events were reported. 4 patients recovered from GvHD |
*ALLELE TRIAL N=43 and EBVCTL 201 N=60.
‘EBV-CTL-201 is a Phase 2 trial with patients treated with EBVALLO: multicentre, open-label study for treatment of EBV viremia or EBV-driven malignancies for whom there are no appropriate alternative therapies10.
ALT, alanine transaminase; AST, aspartate aminotransferase; EBV+, Epstein-Barr virus positive; GvHD, post-transplant lymphoproliferative disease; TFR, tumour flare reaction; WBC, white blood cell.