Updated findings from the Phase 3 ALLELE study, presented at the 66th American Society of Hematology (ASH) Annual Meeting, provide further evidence supporting tabelecleucel as a treatment for relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (R/R EBV+ PTLD).
The study, which included 75 patients (49 solid organ transplant [SOT], 26 hematopoietic cell transplant [HCT]), demonstrated a 50.7% objective response rate (ORR), with a median duration of response (DOR) of 23 months and median overall survival (OS) of 18.4 months.
Tabelecleucel, an off-the-shelf, allogeneic T-cell therapy, targets EBV-infected cells and is designed for patients who have failed prior treatments, including rituximab or rituximab plus chemotherapy. The study confirmed that treatment was generally well tolerated, with no reports of cytokine release syndrome (CRS), tumor flare reactions, immune effector cell-associated neurotoxicity syndrome (ICANS), or organ rejection.
The U.S. Food and Drug Administration (FDA) has granted priority review to tabelecleucel’s biologics license application (BLA), with a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2025. If approved, it would be the first allogeneic T-cell therapy available in the U.S. and the only FDA-approved treatment for R/R EBV+ PTLD, a rare and aggressive hematologic malignancy.
Tabelecleucel was previously approved in Europe under the brand name EBVALLO® in December 2022. In August 2024, the FDA accepted the BLA submission by Atara Biotherapeutics, and in December 2023, Pierre Fabre Laboratories expanded its global partnership to commercialize the therapy beyond Europe, into the United States and additional markets.
These findings highlight the potential role of tabelecleucel in addressing an unmet clinical need for patients facing poor survival outcomes after transplantation. Further developments will depend on the FDA’s final decision in early 2025.
