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Atara Biotherapeutics and Pierre Fabre Laboratories Announce Publication of Phase 3 ALLELE Tab-cel® Data in The Lancet Oncology
First Phase 3 Results Published for an Allogeneic T-Cell Therapy Significant 51.2% Objective Response Rate and 23.0 Month Median Duration of Response in
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nFirst Phase 3 Results Published for an Allogeneic T-Cell Therapy\n\n\nSignificant 51.2% Objective Response Rate and 23.0 Month Median Duration of Response in Relapsed or Refractory EBV+ PTLD Patients\n\n\nU.S. BLA on Track for Submission in Q2 2024 Based on Strong Clinical File\n\n\n THOUSAND OAKS, Calif. & CASTRES, France--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, and Pierre Fabre Laboratories, a global player in oncology and responsible for worldwide commercialization of tabelecleucel (tab-cel® or EBVALLO™), today 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 (EBV+ PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT), were published for the first time online in The Lancet Oncology.\n\n\nThe data were published in an article titled, “Tabelecleucel for allogeneic haematopoietic stem-cell or solid organ transplant recipients with Epstein–Barr virus-positive post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE): a phase 3, multicentre, open-label trial,” and can be accessed at the following link: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00649-6/fulltext\n\n\n“The results of the ALLELE study highlight the clinical value of tab-cel, which is now EMA and MHRA approved, and is being made available to patients in Europe through our partner Pierre Fabre Laboratories as a first-of-its-kind treatment for those with a devastating disease that previously had limited treatment options,” said Pascal Touchon, President and Chief Executive Officer of Atara. “As we prepare for our tab-cel BLA submission in the second quarter 2024, we look forward to interacting with the FDA to progress towards approval based on our robust clinical data.”\n\n\nAs reported in The Lancet Oncology publication, the ALLELE study met its primary endpoint. 22 of 43 EBV+ PTLD patients achieved an objective response (51.2% objective response ...