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

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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 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

 

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ORR results

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

 

1 month
Median number of EBVALLO cycles received
23 months

*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

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switch

% of patients who  
switched to a different lot of EBVALLO1

% of patients who  
achieved a response switching EBVALLO lot1

 

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

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OS curve

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.

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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 5th, 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

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Graph ORR

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.