Mohamad Mohty, MD, PhD, Professor of Hematology at Sorbonne University and Head of the Hematology and Cellular Therapy Department at the Saint Antoine Hospital in Paris, discusses EBV+ PTLD is an aggressive lymphoma that occurs following bone marrow transplant (also known as hematopoietic stem cell transplant, or HCT) or solid organ transplant (SOT). Two Phase 3 clinical studies are underway (MATCH and ALLELE) to evaluate tab-cel in patients with EBV+ PTLD who have failed rituximab following HCT or SOT.
In a study evaluating the activity of tab-cel in treating CNS EBV + PTLD in patients who have failed prior rituximab therapy, the overall response rate was 63 percent of the 19 patients treated in the study. The one-year overall survival (OS) was 60% with responding and non-responding patients demonstrating a one-year OS of 92% and 14%, respectively. Since its discovery as the first human oncovirus, Epstein-Barr virus (EBV) has been implicated in the development of a wide range of lymphoproliferative disorders, including lymphomas and other cancers. EBV is widespread in all human populations and persists as a lifelong, asymptomatic infection.
In immunocompromised patients, such as those undergoing allogeneic hematopoietic cell transplants (HCT) or solid organ transplants (SOT), EBV associated post-transplant lymphoproliferative disorder (EBV+ PTLD), represents a life-threatening condition.
Median overall survival in patients with EBV+ PTLD following HCT who have failed rituximab-based first line therapy is 16-56 days. In EBV+ PTLD following SOT, patients failing rituximab experience increased chemotherapy-induced treatment-related mortality compared to other lymphoma patients. One- and two-year survival in patients with high-risk EBV+ PTLD following SOT is 36% and 0%, respectively.
Tab-cel is an off-the-shelf, allogeneic T-cell immunotherapy in Phase 3 development, has the potential to become the first off-the-shelf, allogeneic T-cell immunotherapy to reach the market.