Tabelecleucel is under clinical development by Atara Biotherapeutics and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Tabelecleucel’s likelihood of approval (LoA) and phase transition for Epstein–Barr Virus (HHV-4) Infections took place on 20 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 20 Dec 2022 increased Tabelecleucel’s LoA and PTSR for Hodgkin Lymphoma (B-Cell Hodgkin Lymphoma), increased LoA and PTSR for Non-Hodgkin Lymphoma, increased LoA and PTSR for Post-Transplant Lymphoproliferative Disorder, and increased LoA and PTSR for Solid Tumor.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Tabelecleucel Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Tabelecleucel overview

Tabelecleucel (Ebvallo) is an allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy. It is formulated as a dispersion for injection for the intravenous route of administration. Ebvallo is indicated as monotherapy for the treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

ATA-129 is under development for the treatment of rituximab-refractory, Epstein-Barr Virus-Associated post-transplant lymphoproliferative disease (PTLD) after solid organ transplantation (SOT) and allogeneic hematopoietic cell transplantation (HCT), hemophagocytic lymphohistiocytosis, hodgkin lymphoma (b-cell hodgkin lymphoma), non-hodgkin lymphoma, solid tumor and lymphoproliferative disorders. Allogeneic EBV specific cytotoxic T- lymphocytes are administered as an intravenous infusion. It is developed based on allogeneic, or off-the-shelf, cytotoxic T-lymphocytes (CTLs) directed against multiple epitopes of the Epstein-Barr virus (EBVpoly) and multiple epitopes of the cytomegalovirus (CMVpoly) utilizing technology.

It was also under development for EBV associated gastric cancer, nasopharyngeal cancer, leiomyosarcoma and lymphomas.

Atara Biotherapeutics overview

Atara Biotherapeutics (Atara) is a biopharmaceutical company specialized in T-cell immunotherapy. The company uses its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop therapies for the treatment of cancers, other autoimmune diseases, and severe viral infections. It is evaluating its lead candidate, tabelecleucel in Phase III clinical trials for the treatment of epstein-barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) following hematopoietic cell transplant and solid organ transplant in patients who refracted rituximab. Its pipeline product candidates that are being developed for multiple indications in various stages of clinical trials include ATA188, ATA2271, ATA3219, ATA3271 and other CAR T programs. Atara is headquartered in South San Francisco, California, the US.

Quick View Tabelecleucel LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Tabelecleucel
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Hematological Disorders
  • Infectious Disease
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.