Efficacy | EBVALLO

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

*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 transplant; HLA, human leukocyte antigens; IV, intravenous; ORR, objective response rate; OS, overall survival; PTLD, post-transplant lymphoproliferative disease; SOT, solid organ transplant; TTR, time to response.

OBJECTIVE RESPONSE RATE (ORR)

In the ALLELE study, 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.

BEST RESPONSE RATE

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

*Independent oncologic response adjudication (IORA)-assessed response

Patients not obtaining a partial or complete response may still benefit from switching to a new lot with a different HLA restriction¹

DOR, duration of response; EBV+,Epstein-Barr virus positive; HLA, human leukocyte antigen; ORR, objective response rate; OS, overall survival; PTLD, post-transplant lymphoproliferative disease; SOT, solid organ transplantation; TTR, time to response.

OVERALL SURVIVAL (OS)

ALLELE: Patients have a median OS of 18.4 months in the overall population (HCT and SOT)¹

1-years OS rate after treatment with EBVALLO¹

84%

Responders (n=22)
(95% CI: 58.9–94.7)

35%

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

More information on OS data in HCT and SOT cohorts

Data cut-off: November 5th, 2021.

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.

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.

I certify that:

I am a healthcare professional inside the EU and I have read the information above, the Legal Notice and the Privacy Policy

Non Healthcare Professionals

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

I am not a healthcare professional inside the EU.

All HCT patient responders and 75% of SOT patient responders were alive at 1 year in ALLELE¹

1-year OS rate, % (95%Cl)

HCT (n=14)

SOT (n=29)

All Patients (n=43)

70%

(38.5–87.6)

56%

(34.6-73.2)

Responders (n=22)

100%

(NA)

75%

(40.7-91.4)

Non-responders (n=22)

36%

(2.0-35.4)

33%

(10.4-59.1)

Median follow-up, months (range)

14.1 months
(2.0-35.4)

6.0 months
(0.1-35.4)

Baseline patient demographics

At the data cut-off date, 43 patients with EBV+PTLD were treated with EBVALLO in the ALLELE study, including adults and paediatrics¹

	BASELINE PATIENT CHARACTERISTICS
	HCT (n=14)	SOT (n=29)	All (n=43)
Median age, years (range)	51.9 (3.2-73.2)	44.4 (6.1-81.5)	48.5 (3.2-81.5)
Male, n (%)	8 (57.1)	16 (55.2)	24 (55.8)
ECOG score (age ≥ 16 years)* n ECOG < 2, n (%) ECOG ≥ 2, n (%) Missing, n (%)	13 10 (76.9) 3 (23.1) 0	27 18 (66.7) 8 (29.6) 1 (3.7)	40 28 (70.0) 11 (27.5) 1 (2.5)
PTLD-adapted prognostic index**(age ≥ 16), n (%) Low risk Intermediate risk High risk Unknown	1 (7.7) 6 (46.2) 6 (46.2) 0	2 (7.4) 13 (48.1) 11 (40.7) 1 (3.7)	3 (7.5) 19 (47.5) 17 (42.5) 1 (2.5)
PTLD morphology/history, n (%) DLBCL Other Plasmablastic lymphoma	10 (71.4) 3 (21.4) 1 (7.1)	19 (65.5) 8 (27.6) 2 (6.9)	29 (67.4) 11 (25.6) 3 (7.0)
Extranodal disease	9 (64.3)	24 (82.8)	33 (76.7)
Prior therapies Median no. of prior systemic therapies (range) Rituximab monotherapy, n (%) Rituximab monotherapy as 1L, n (%) Chemotherapy-containing regimen^***, n (%)	1.0 (1-4) 14 (100) 14 (100) 3 (21.4)	1.0 (1-5) 23 (79.3) 22 (75.9) 16 (552)	1.0 (1-5) 37 (86.0) 36 (83.7) 19 (44.2)

Data cut-off : November 5^th, 2021.
*Percentages for ECOG were based on the number of patients in the corresponding age group.
^**Disease risk for PTLD patients was assessed at baseline using the PTLD_adapted prognostic index (based on age, ECOG score and serum LDH level).
^***Chemotherapy regimens could have also been combined with rituximab or other immunotherapy agents.

1L, first-line; EBV+, Epstein-Barr virus positive; DLBCL, diffuse large B-cell lymphoma; ECOG, Eastern Coorperative Oncology Group; HCT, haematopoietic cell transplantation; LDH, lactate dehydrogenase; PTLD, post transplant lymphoproliferative disease; SOT, solid organ transplantation

SOT patient subgroup analysis for the ORR¹

Objective response rate (ORR) with EBVALLO in SOT patients:
Subgroup analysis for patients who previously reveived R+C and R only

Data cut-off: November 5th, 2021.
CR, comlere response; ORR, objective response rate; PR, partial response; R, rituximab; R+C, rituximab + chemotherapy; SOT, solid organ transplantation.