ATARA Biotherapeutics (ATRA) Releases First Data from European Multi-Center Tab-cel Expanded Access Program


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Atara Biotherapeutics, Inc. (Nasdaq: ATRA) today announced EMA regulatory progress and clinical results for tabelecleucel (tab-cel®). Data are from the Expanded Access Program (EAP) multicenter study in Europe for patients with relapsed or refractory (r/r) post-transplant lymphoproliferative disease (EBV+PTLD) due to Epstein virus -Barr following solid organ transplant (SOT) or hematopoietic cell transplant (HCT) and will be the subject of a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting which will be held June 3-7, 2022 in Chicago, IL.

In the ongoing EAP, 22 patients from leading 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 main objective of the This study is to describe the demographics and disease characteristics of patients with EBV+ disease treated with tab-cel as part of EAP. The secondary objectives are to describe the tab-cel dosing regimen, assess clinically relevant treatment outcomes, and describe the safety of tab-cel in patients with EBV+ disease treated under the EAP.

Of the 16 EBV+ PTLD patients, 15 received at least one dose of tab-cel. Overall, nine out of 15 (60%) patients treated with tab-cel achieved a physician-assessed response, with six complete responses (CR) and three partial responses (PR). Of the nine responses, eight were observed after the first round of tab-cel treatment.

The safety results were consistent with previously published data. All treatment-related events were assessed as unrelated to tab-cel by the treating physician and were consistent with the patients’ underlying illnesses. Further details on basic demographics and disease characteristics, as well as additional safety data, including details on tab-cel exposure, will be presented at the conference.

“We are delighted to share the latest data from our EAP in Europe demonstrating clinically meaningful results for patients with EBV+ PTLD, a rare and aggressive disease with no approved treatment options, consistent with the favorable safety and efficacy profile previously reported studies, including the pivotal Phase 3 ALLELE study,” said Jakob Dupont, MD, Head of Global Research and Development, Atara. “Furthermore, we now welcome the completion of our pre-approval inspections as a key milestone on our road to obtaining approval in the EU.”

Additionally, Atara announced the completion of the six pre-approval inspections required to support the marketing authorization application for tab-cel in Europe, with the required Good Manufacturing Practices (GMP) certificates of compliance. to support the planned filing by July. Combined with the recent 120-day critical appraisal report, in which the European Medicines Agency (EMA) considered comparability data between clinical and commercially manufactured versions to be sufficient to demonstrate comparability, Atara continues to expect approval from the European Commission in the fourth quarter of 2022.

Details of the ASCO presentation:

  • Title: Demographics and treatment outcomes in patients with EBV+ PTLD treated with ready-to-use EBV-specific (tabelecleucel) CTLs in an ongoing expanded access program in Europe: initial analyses.
  • Speaker: Ralf Trappe, MD, DIAKO Evangelisches Diakonie-Krankenhaus Bremen, Bremen, Germany
  • Date and hour : Saturday, June 4, 2022, 8 a.m. to 11 a.m. CDT/6 a.m. to 9 a.m. PDT
  • Abstract number: 7530
  • Poster number: 184
  • Session: Hematological malignancies—lymphoma and chronic lymphocytic leukemia
  • Location: McCormick Place Convention Center Chicago, Hall A

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