Pharmaceutical Company Issues Development Updates for Tabelecleucel in EBV+ PTLD

Atara Biotherapeutics has transferred the Investigational New Drug Application for tabelecleucel, an off-the-shelf allogeneic T-cell immunotherapy for Epstein-Barr virus–associated post-transplant lymphoproliferative disease (EBV+ PTLD), to Pierre Fabre Pharmaceuticals.¹

Atara Biotherapeutics also resubmitted a Biologics License Application for tabelecleucel after a Complete Response Letter relating to third-party manufacturing facility observations was issued by the FDA in January 2025.¹

Pierre Fabre Pharmaceuticals now assumes global responsibility for all clinical development of tabelecleucel, including the ongoing, multicenter, open-label, phase 3 ALLELE study of 63 patients with relapsed or rituximab-refractory EBV+ PTLD after solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT).^1,2

Results published in The Lancet Oncology showed that tabelecleucel provides clinical benefit without safety concerns.² The objective response rate was 50% among patients who received prior HSCT and 52% among patients who received prior SOT. The most common grade 3 or 4 treatment-emergent adverse events were disease progression (29% in the HSCT group and 28% in the SOT group) and decreased neutrophil count (29% in the HSCT group and 14% in the SOT group).²

Another multicenter, open-label, single-arm, phase 2 trial will evaluate tabelecleucel in patients with EBV-associated diseases, including EBV+ sarcomas and EBV+ PTLD for which standard first-line therapy is inappropriate.^1,3

In March 2025, Pierre Fabre Pharmaceuticals also assumed responsibility for manufacturing tabelecleucel in the European Union, where the immunotherapy was approved in December 2022.⁴