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e-Poster Display Session

29P - ALLELE study: A multicenter, open label, phase III study of tabelecleucel for solid organ or allogeneic hematopoietic cell transplant subjects with Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) after failure of rituxima

Date

09 Dec 2020

Session

e-Poster Display Session

Presenters

Nina Worel

Citation

Annals of Oncology (2020) 31 (suppl_7): S1425-S1427. 10.1016/annonc/annonc390

Authors

N. Worel1, J.A. Perez-Simon2, P. Barba3, D. Dierickx4, M. Hiremath5

Author affiliations

  • 1 Medical University Vienna, Vienna/AT
  • 2 Universidad de Sevilla, Sevilla/ES
  • 3 Hospital Universitari Vall d'Hebrón Universitat Autònoma de Barcelona, Barcelona/ES
  • 4 University Hospitals Leuven, Leuven/BE
  • 5 Atara Biotherapeutics, San Francisco/US
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Abstract 29P

Background

Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) is a rare and potentially life-threatening disease in the setting of immunosuppression following solid organ (SOT) or allogeneic hematopoietic cell transplant (HCT). Treatment of relapsed/refractory EBV+ PLTD is inadequate and has poor overall survival, highlighting a clear unmet medical need. Challenges with current therapies include limited efficacy, potential for graft rejection, or graft-vs-host disease (GvHD), and high mortality.

Methods

Tabelecleucel is an off-the-shelf, allogeneic EBV-specific T cell therapy. Here we describe the design of an ongoing multicenter study of tabelecleucel for subjects with EBV+ PTLD after failure of rituximab (R) + chemotherapy (CT) which has recently opened for enrolment in Europe. ALLELE is evaluating the benefit/risk of tabelecleucel in SOT patients following treatment with R or R plus CT (N=33) and in HCT patients following treatment with R (n=33) (NCT03394365). Key inclusion criteria: biopsy-proven EBV+PTLD and failure of R + CT. Tabelecleucel is selected for each patient from an inventory based on an EBV HLA-restricting allele and a second shared allele. During each treatment cycle, tabelecleucel is administered intravenously at a dose of 2x106 cells/kg on days 1, 8, 15, followed by observation through day 35. Responses per radiographic and clinical assessment are evaluated at the end of each cycle using modified Lugano criteria. Patients receive additional treatment cycles until they meet end of treatment criteria. A restriction switch (tabelecleucel with different HLA-restriction) is permitted for patients with stable or progressive disease.

Results

After ending treatment, subjects are assessed quarterly up to 24 months for disease status, and biannually thereafter, up to 5 years, for survival status.

Conclusions

The primary endpoint of the study is overall response rate (ORR), assessed by independent review, following the administration of tabelecleucel.

Clinical trial identification

NCT03394365.

Legal entity responsible for the study

The authors.

Funding

Atara Biotherapeutics.

Disclosure

N. Worel: Advisory/Consultancy, travel support: Celgene BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Sanofi Genzyme; Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Kite Gilead; Speaker Bureau/Expert testimony, travel support: Therakos Mallinckrodt. J.A. Perez-Simon: Advisory/Consultancy, Research grant/Funding (self): Novartis; Advisory/Consultancy: Kite; Advisory/Consultancy: Janssen; Advisory/Consultancy: Amgen; Advisory/Consultancy, Research grant/Funding (self): Celgene BMS; Advisory/Consultancy, Research grant/Funding (self): Takeda. P. Barba: Honoraria (self): Amgen; Honoraria (self): Celgene; Honoraria (self): Gilead; Honoraria (self): Jazz Pharamceuticals; Honoraria (self): Novartis; Honoraria (self): Pfizer. D. Dierickx: Advisory/Consultancy: Takeda; Advisory/Consultancy: Atara; Research grant/Funding (self): Roche. M. Hiremath: Honoraria (institution), employee and stockholder of Atara Biotherapeutics: Atara Biotherapeutics. W. Ye: Honoraria (institution), employee and stockholder of Atara Biotherapeutics: Atara Biotherapeutics. L. Gamelin: Honoraria (institution), employee and stockholder of Atara Biotherapeutics: Atara Biotherapeutics. W.H. Navarro: Honoraria (institution), employee and stockholder of Atara Biotherapeutics: Atara Biotherapeutics. S. Choquet: Speaker Bureau/Expert testimony: Atara; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Sandoz; Speaker Bureau/Expert testimony: Biogaran; Speaker Bureau/Expert testimony: Accord Healthcare.

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