On June 4, 2022 Atara 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, reported EMA regulatory progress and tabelecleucel (tab-cel) clinical outcomes (Press release, Atara Biotherapeutics, JUN 4, 2022, View Source [SID1234615573]). 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) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022, in Chicago, IL.

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In 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.

Of 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.

Safety 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 including tab-cel exposure details, will be presented at the conference.

"We are pleased to share the latest data from our EAP in Europe demonstrating clinically meaningful outcomes for patients with EBV+ PTLD, a rare and aggressive disease with no approved treatment options, in line with the favorable safety and efficacy profile from previously reported studies including the pivotal Phase 3 ALLELE study," said Jakob Dupont, M.D., Head of Global Research & Development at Atara. "In addition, we now welcome the completion of our pre-approval inspections as a key milestone on our road to achieving approval in the EU."

Separately, Atara announced completion of all six pre-approval inspections required to support the Marketing Authorization Application for tab-cel in Europe, with the Good Manufacturing Practice (GMP) compliance certificates required to support the filing expected by July. Combined with the recent Day 120 critical assessment report, where the European Medicines Agency (EMA) considered the comparability data between clinical and commercial manufacturing versions as sufficient to demonstrate comparability, Atara continues to expect European Commission approval in Q4 2022.

ASCO presentation details:

Title: Demographics and treatment outcomes in patients with EBV+ PTLD treated with off-the-shelf EBV-specific CTL (tabelecleucel) under an ongoing expanded access program in Europe: First analyses.
Presenting Author: Ralf Trappe, M.D., DIAKO Evangelisches Diakonie-Krankenhaus Bremen, Bremen, Germany
Date & Time: Saturday, June 4, 2022, at 8-11 a.m. CDT/6-9 a.m. PDT
Abstract Number: 7530
Poster Number: 184
Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Location: McCormick Place Convention Center Chicago, Hall A