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Atara Biotherapeutics Announces First Clinical Data from Ongoing Tab-cel® European Multicenter Expanded Access Program (EAP) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and Update on Tab-cel EMA Regulatory Progress
Overall Response Rate (ORR) of 60% Observed in Patients with Relapsed or Refractory (R/R) EBV+ PTLD Consistent with Previously Reported Studies Completion of
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nOverall Response Rate (ORR) of 60% Observed in Patients with Relapsed or Refractory (R/R) EBV+ PTLD Consistent with Previously Reported Studies\n\nCompletion of All Pre-Approval Inspections Required to Support EU Marketing Authorization Application; Anticipated European Commission Approval On-Track for Q4 2022\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced EMA regulatory progress and tabelecleucel (tab-cel®) clinical outcomes. Data is reported from the multicenter Expanded Access Program (EAP) study in Europe for patients with relapsed or refractory (r/r) Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT) and will be featured in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3-7, 2022, in Chicago, IL.\n\nIn the ongoing EAP, 22 patients from the first European centers consented to this observational study, of which 16 patients presented with EBV+ PTLD and six with EBV+ non-PTLD between July 2020 and November 2021. The primary objective of the study is to describe the demographics and disease characteristics of patients with EBV+ diseases treated with tab-cel under the EAP. Secondary objectives are to describe the tab-cel dosing pattern, to evaluate clinically relevant treatment outcomes, and to describe the safety of tab-cel in patients with EBV+ diseases treated under the EAP.\n\nOf the 16 EBV+ PTLD patients, 15 received at least one dose of tab-cel. Overall, nine out of 15 (60%) tab-cel treated patients achieved a response as assessed by the treating physician, with six complete responses (CRs) and three partial responses (PRs). Of the nine responses, eight were observed after the first treatment cycle of tab-cel.\n\nSafety findings were consistent with previously published data. All treatment-emergent events were assessed as unrelated to tab-cel by the treating physician and were consistent with patients’ underlying diseases. Further detail on baseline demographics and disease characteristics, and additional safety data i...