Efficacy | EBVALLO

ALLELE STUDY DESIGN

A multicentre, open-label, Phase 3 study of EBVALLO after failure of rituximab ± CT in patients with EBV+ PTLD following HCT or SOT^1,8

*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 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 EBVALLO^1,2

Patients not obtaining a partial or complete response may still benefit from switching to a new lot with a different HLA restriction³

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)²

1-years OS rate after treatment with EBVALLO²

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)

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.

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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.