Armin Ghobadi, MD, Professor of Medicine and Clinical Director of the Center for Gene and Cellular Immunotherapy at Washington University, discusses results from the ALLELE clinical trial for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
EBV+ PTLD is a rare hematologic malignancy caused by compromised T-cell immune responses following transplantation. The condition can impact both solid organ transplant (SOT) patients and allogeneic hematopoietic cell transplant (HCT) patients. EBV+ PTLD can cause median survival of three weeks (HCT) and about four months (SOT) when patients are unresponsive to standard of care treatments.
The ALLELE clinical trial was a phase 3, multicenter, open-label study evaluating the safety and efficacy of tabelecleucel for the treatment of patients two years of age and older with EBV+ PTLD following SOT or HCT. Tabelecleucel is an investigational allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells.
The results from the study included a 50.7% objective response rate in patients receiving tabelecleucel, with SOT at 51% and HCT at 50%. Median duration of response was 23 months and median overall survival was 18.4 months. Serious treatment emergent adverse events were reported in 65.4% of HCT and 61.2% of SOT patients, consistent with previous data.
The U.S. Food and Drug Administration (FDA) has accepted a BLA submission and granted priority review for tabelecleucel for the treatment of patients ages two years and older with refractory EBV+ PTLD. On January 16, 2025 the FDA issued a Complete Response Letter.
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To learn more about EBV+ PTLD and other rare hematologic conditions, visit https://checkrare.com/diseases/hematologic-disorders/