Tab-cel (tabelecleucel) / Atara, Pierre Fabre - LARVOL DELTA

Subgroup analysis in pediatric patients from the Phase 3 study of tabelecleucel for allogeneic or solid organ transplant recipients with Epstein–Barr virus-driven post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE) (ASH 2025) - "This analysis of 12 pediatric patients from the ALLELE trial suggests that the risk/benefitprofile in the pediatric subgroup is consistent with that reported in the overall population, with an ORR of50% (6/12 patients) and 5/6 treatment responders still alive at data cutoff. These findings support the useof tabelecleucel in pediatric patients with R/R EBV+ PTLD who have historically poor survival and verylimited treatment options. The safety profile of tabelecleucel was favorable and no new concerns wereidentified for the pediatric population."

Clinical • P3 data • Post-transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Infectious Disease • Pediatrics • Solid Organ Transplantation • Transplant Rejection • Transplantation

Subgroup analysis based on prior treatment from the Phase 3 allele study of tabelecleucel for epstein-barr virus-driven post-transplant lymphoproliferative disease (ASH 2025) - P3 | "Here we present updated results from alarger number of patients (29 HCT, 57 SOT) focusing on a subgroup analysis based on prior treatment. Eligibility criteria required HCT patients to have failed prior treatment with rituximab, and SOTpatients to have failed prior treatment with rituximab (SOT-R) or rituximab and chemotherapy (SOT-RC).Patients received intravenous tabelecleucel at 2 x 106 cells/kg on days 1, 8, and 15 in 35-day cycles.Clinical and radiographic assessments were conducted toward the end of each cycle and treatmentresponse evaluated by independent oncologic response adjudication (IORA). Results from the ALLELE trial continue to demonstrate the efficacy of tabelecleucel with anORR of 48.3% in the HCT cohort and 47.4% in the SOT cohort. A favorable, but not a statistically significantORR for SOT-R compared with SOT-RC was observed. Overall, these findings represent a novel treatmentoption for patients with R/R EBV+ PTLD who have poor survival and no..."

P3 data • Post-transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Solid Organ Transplantation • Transplant Rejection • Transplantation

Pierre Fabre Pharmaceuticals Announces Updated Phase 3 Tabelecleucel Data at American Society of Hematology Meeting in Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) (PRNewswire) - "The updated findings showed patients receiving tabelecleucel had an objective response rate (ORR) of 47.7% with the HCT cohort achieving an 48.3% ORR and SOT cohort achieving a 47.4% ORR. The median (95% CI) overall survival (OS) from Kaplan-Meier survival estimates for the HCT cohort was 18.6 months. For the SOT cohort, median OS was not estimable as more than half of the patients remained in follow-up. In a sub-analysis of treatment response by prior therapy in SOT patients, ORR was 52.4% for those receiving rituximab and 44.4% for those receiving rituximab and chemotherapy."

P3 data • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

Tabelecleucel (tab-cel or Ebvallo) for Post-Transplant Lymphoproliferative Disease (PTLD) (Businesswire) - "Atara expects to receive an additional $40 million milestone payment from Pierre Fabre Laboratories contingent upon FDA approval of the tab-cel BLA."

Commercial • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

Updated Clinical Results: A Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Recipients with Epstein–Barr Virus-Driven Post Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab Plus Chemotherapy (ASH 2024) - P3 | "The safety profile remains consistent with previous findings. These results represent a potential new treatment paradigm for pts with R/R EBV+ PTLD."

Clinical • P3 data • Post-transplantation • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Infectious Disease • Solid Organ Transplantation • Transplantation

Successful treatment of EBV-positive lymphomatoid granulomatosis with tabelecleucel (DGHO 2025) - P2 | "Detailed data were obtained from electronic chart review, complemented by a mini-review of the literature.Results/Case description: Initial diagnosis was obtained by lung biopsy in 2017 and treated with rituximab (R) + CHOP chemoimmunotherapy, resulting in a metabolic complete remission. Tab-cel is currently being evaluated for other EBV-related diseases in a phase II basket trial (NCT04554914). Our report underscores the potential use of tab-cel for the treatment of LYG, contributing to the yet scarce experience on the use of immunotherapy in LYG."

Epstein-Barr Virus Infections • Hematological Malignancies • Lymphoma • T Cell Non-Hodgkin Lymphoma

Pierre Fabre Pharmaceuticals Announces Transfer from Atara Biotherapeutics of the Biologics License Application (BLA) for Tabelecleucel as Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) (PRNewswire) - "The tabelecleucel BLA has an FDA PDUFA target action date of January 10, 2026....The BLA includes data covering more than 430 patients treated with tabelecleucel including the ongoing pivotal ALLELE study investigating the therapy in adults and children two years of age and older with relapsed or refractory EBV+ PTLD following SOT or HCT."

FDA filing • PDUFA • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

ALLELE: A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy (clinicaltrials.gov) - P3 | N=115 | Recruiting | Sponsor: Pierre Fabre Medicament | N=66 ➔ 115

Enrollment change • Acute Lymphocytic Leukemia • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

UPDATED CLINICAL RESULTS. A MULTICENTER, OPEN-LABEL, PHASE 3 STUDY OF TABELECLEUCEL FOR SOLID ORGAN OR ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT RECIPIENTS WITH EBV-DRIVEN PTLD AFTER FAILURE OF RITUXIMAB +/- CHEMOTHERAPY (SIE 2025) - P3 | "Updated ALLELE data confirm tabelecleucel's efficacy (ORR 50.7%, median DOR 23.0 months, OS 18.4 months) in R/R EBV+PTLD, in patients who otherwise have a median OS of 0.7-4.1 months in the absence of available treatment options. Safety remained favorable with no treatment-related fatalities or expected immune toxicities, supporting tabelecleucel as a potential new standard for this high-risk population."

Clinical • P3 data • Bone Marrow Transplantation • Transplantation

ALLELE: Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy (clinicaltrials.gov) - P3 | N=66 | Recruiting | Sponsor: Pierre Fabre Medicament | Trial primary completion date: Aug 2025 ➔ May 2030

Trial primary completion date • Acute Lymphocytic Leukemia • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

ALLELE: Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy (clinicaltrials.gov) - P3 | N=66 | Recruiting | Sponsor: Pierre Fabre Medicament | Trial completion date: Jun 2027 ➔ Aug 2030

Trial completion date • Acute Lymphocytic Leukemia • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

Updated Clinical Results From the ALLELE Trial: A Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Recipients with Epstein-Barr Virus (EBV)-Driven Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab Plus Chemotherapy (SOHO 2025) - P3 | "Longer-term follow-up confirms the clinical benefit of tabelecleucel in R/R EBV+ PTLD post standard of care, with ORR of 51%, median DOR of 23.0 months, and favorable median OS of 18.4 months. The safety profile remains favorable and consistent with previous reports."

Clinical • P3 data • Post-transplantation • Oncology

EBVision: A Study to Evaluate Tabelecleucel in Participants With Epstein-barr Virus (EBV)-Associated Diseases (clinicaltrials.gov) - P2 | N=190 | Recruiting | Sponsor: Pierre Fabre Medicament | Trial completion date: May 2029 ➔ May 2028

Trial completion date • CNS Disorders • Epstein-Barr Virus Infections • Immunology • Leiomyosarcoma • Oncology • Primary Immunodeficiency • Sarcoma • Solid Organ Transplantation • Solid Tumor • Transplantation • CD20

Atara Biotherapeutics Announces Second Quarter Financial Results and Operational Progress (Businesswire) - "Under its commercialization agreement with Pierre Fabre Medicament, Atara is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA. In addition, Atara will be eligible to receive double-digit tiered royalties as a percentage of net sales and milestones related to commercial sales of EBVALLO. We anticipate the full-year 2025 operating expenses will decrease by at least 60% compared to 2024..."

Commercial • Post-Transplant Lymphoproliferative Disorders

Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (Businesswire) - "Atara Biotherapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy...The BLA has been granted Priority Review with a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026."

FDA filing • PDUFA • Priority review • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

Perre Fabre Pharmaceuticals, Inc. Announces Transfer of Investigational New Drug Application for Tabelecleucel from Atara Biotherapeutics, Inc. (PRNewswire) - "Pierre Fabre Pharmaceuticals, Inc. today announced the transfer of the Investigational New Drug Application for tabelecleucel from its partner, Atara Biotherapeutics, Inc....'This announcement marks an important milestone as Pierre Fabre Laboratories assumes global responsibility for clinical development of tabelecleucel following transfer of manufacturing responsibilities earlier in the year.'"

Commercial • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

Corporate Updates (Businesswire) - "The company is finalizing the transfer of the following clinical studies associated with tab-cel: NCT03394365; NCT04554914...Upon completion substantially all operational activities and associated costs related to tab-cel will transfer to Pierre Fabre Laboratories. The sponsorship of the BLA continues to be maintained by Atara...Additionally, under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA, as well as significant double-digit tiered royalties as a percentage of net sales, and milestones related to commercial sales of EBVALLO."

Commercial • Trial status • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

Atara Biotherapeutics Provides Regulatory and Business Updates on Tabelecleucel (Tab-cel) (Businesswire) - "Atara Biotherapeutics, Inc...announced that it has resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (EBVALLO or tab-cel) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy...The BLA is supported by pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases, including the latest pivotal ALLELE study data that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001) and favorable safety profile consistent with previous analyses."

FDA filing • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

TABELECLEUCEL IN EBV POSITIVE POST-TRANSPLANT LYMPHOPROLIFERATIVE DISEASE: A REAL WORD EXPERIENCE (ICML 2025) - "Our single center experience showed that tabelecleucel therapy is feasible in a real word setting. Time from "brain to vein" is short, thus preventing disease progression in the majority of cases. In our experience tabelectelucel can represent a good alternative to chemotherapy in EBV positive Rituximab resistant/refractory lymphoproliferative disorders."

Post-transplantation • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Lymphoma

Updated Results: Ph 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Recipients with EBV+ PTLD after Rituximab+/- Chemotherapy Failure (ICML 2025) - P3 | "Updated results from the ALLELE study confirm tab-cel efficacy with an ORR of 50.7% in 75 pts, along with DOR of ∼23 months and median OS of 18.4 months, in patients who otherwise have a median OS of 0.7–4.1 months in the absence of available treatment options. The safety profile remains consistent with previous findings. These results represent a potential new treatment paradigm for pts with R/R EBV+ PTLD."

Clinical • Lymphoma

Adoptive Cell Immunotherapy in Relapse/Refractory Epstein-Barr Virus-Driven Post-Transplant Lymphoproliferative Disorders. (PubMed, Antibodies (Basel)) - "This review aims to provide an overview of PTLD treatment with a specific focus on adoptive cellular immunotherapy. We highlight the most robust clinical outcomes reported with EBV-CTLs, particularly those achieved with tabelecleucel, and explore emerging cellular approaches such as CAR T-cell therapy, which may further broaden therapeutic strategies in the near future."

Journal • Review • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

Pierre Fabre Charting a new course in EBV+ PTLD with allogeneic T-cell immunotherapy (ICML 2025) - "We will then present the latest EBVALLO▼ (tabelecleucel) data from the ALLELE clinical trial in improving outcomes for patients with relapsed/refractory EBV+ PTLD and discuss real-world clinical experience with EBVALLO▼(tabelecleucel). We also want to hear from the audience during our symposium so please come ready to share your insights or challenges in managing patients with EBV+ PTLD, and guided by our faculty, together we can explore the future directions of treatment of EBV+ PTLD."

IO biomarker • Lymphoma

Tabelecleucel in Post-transplant Epstein-Barr Virus-Associated Lymphoproliferative Disease: Patient and Oncologist Perspectives. (PubMed, Adv Ther) - "The patient's parents offer a deeply personal perspective, reflecting on several years of struggle marked by unwavering hope and trust in the medical professionals who have supported their daughter throughout her journey. The pediatric hemato-oncologist who advocated for the use of tabelecleucel described the case as unique worldwide.Their joint testimony tells the remarkable story of how tabelecleucel, despite an initially unclear biological rationale, achieved a reversal of a severe case of EBV + PTLD that had progressed to a point considered beyond recovery and associated with a dire prognosis."

Journal • Epstein-Barr Virus Infections • Oncology • Pediatrics • Transplantation

Evaluating PICOs Requested by Member States During Scoping for EU HTA Versus Those Covered in Actual HTAs (ISPOR 2025) - "We aimed to assess the alignment between PICOs identified in EUnetHTA 21 scoping surveys for PLUVICTO®, EBVALLO® and POMBILITI™ published in 2023, versus PICOs considered in actual HTAs of these products. PICOs included in actual HTAs were predicted by the EUnetHTA 21 scoping exercise; however, there may be over-scoping of PICOs due to the scoping process and requirement to meet all member states' needs. This may place an unnecessary burden on manufacturers responding to irrelevant PICOs and manufacturer input into the scoping of EU JCAs could be beneficial"

Atara Biotherapeutics Provides Regulatory Updates on EBVALLO (tabelecleucel) (Businesswire) - "Atara Biotherapeutics...announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Atara’s active Investigational New Drug (IND) applications for the EBVALLO (tabelecleucel) program....In January 2025, the EBVALLO (tabelecleucel) program was placed on clinical hold....The FDA has lifted the clinical hold on tabelecleucel after reviewing supplemental data on finished drug product. The Company is now allowed to restart the Phase 3 ALLELE clinical study for patients with Epstein-Barr Virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) and the Phase 2 label-expansion multi-cohort clinical study. The FDA has also granted a date for a Type A meeting to discuss the plan to address the issues raised by the FDA in the CRL from January 2025, and the path forward for resubmission of the EBVALLO BLA."

FDA event • Trial status • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders