Atara Biotherapeutics’ tabelecleucel meets primary endpoint in Phase 3 study

Atara Biotherapeutics and Pierre Fabre Laboratories, a player in oncology and responsible for worldwide commercialization of tabelecleucel, announced that data from the pivotal Phase 3 ALLELE study of tab-cel, approved in the European Union in adults and children two years of age and older with relapsed or refractory – r/r – Epstein-Barr virus positive post-transplant lymphoproliferative disease, or EBV+ PTLD, following solid organ transplant or hematopoietic cell transplant, were published for the first time online in The Lancet Oncology. The ALLELE study met its primary endpoint. 22 of 43 EBV+ PTLD patients achieved an objective response – 51.2% objective response rate. Those that responded to tab-cel had longer survival, with an estimated one-year overall survival of 84.4% for responders versus 34.8% for non-responders. The median duration of response was 23.0 months and the median overall survival was 18.4 months. Tab-cel was well tolerated with no reports of tumor flare reaction, cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome, and no events of graft-versus-host disease or SOT rejection as related to tab-cel. Tab-cel was granted marketing authorization under the brand name EBVALLO in December 2022 by the European Commission as a monotherapy for the treatment of adult and pediatric patients two years of age and older with r/r EBV+ PTLD who have received at least one prior therapy. In the U.S., Atara plans to submit a biologics license application to the FDA for tab-cel for the treatment of EBV+ PTLD in Q2.