A recent study presented at the ASH Annual Meeting and Exposition revealed that tabelecleucel, an off-the-shelf allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T-cell therapy, offers durable benefits to patients with EBV-driven post-transplant lymphoproliferative disease (PTLD). The phase 3 ALLELE trial included 75 patients, with a median age of 44.4 years, who had undergone either solid organ transplant or allogeneic hematopoietic cell transplant (HSCT).
Patients received tabelecleucel at a dose of 2 x 10^6 cells/kg on days 1, 8, and 15 of each 35-day cycle. The study aimed to assess the efficacy and safety of the therapy, with key endpoints including overall response rate (ORR), duration of response, time to response, and overall survival (OS).
The results showed an ORR of 50.7% across the entire cohort, with similar response rates observed in both solid organ transplant and HSCT patients. The median time to response was 1.1 months, and the median duration of response was 23 months. Notably, more than half of the complete or partial responses lasted at least 6 months. The median OS for the entire study population was 18.4 months, with 1-year OS rates of 55.7% overall, 57.1% for solid organ transplant patients, and 52.4% for HSCT patients.
Patients who responded to tabelecleucel had a significantly higher 1-year OS rate (78.7%) compared to non-responders (28.2%). The therapy was well-tolerated, with no reports of tumor flare reactions, infusion reactions, cytokine release syndrome, or other serious adverse events related to the treatment. Importantly, there were no cases of tabelecleucel-related graft vs host disease or organ rejection.
These findings suggest that tabelecleucel represents a promising treatment option for patients with EBV-driven PTLD, offering both efficacy and a favorable safety profile.
