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Atara Biotherapeutics To Present Positive New Tab-cel® Clinical Data During Oral Session at ESMO Immuno-Oncology Annual Congress 2023
Combined Analysis That Includes First Reported Data from Multicohort Phase 2 EBVision Trial Consistent with Previous Single-Center Experience Pooled Analysis
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nCombined Analysis That Includes First Reported Data from Multicohort Phase 2 EBVision Trial Consistent with Previous Single-Center Experience\n\n\nPooled Analysis Shows 77.8% Objective Response Rate (ORR) in 18 EBV+ CNS PTLD Patients, Including First Line PTLD Setting and Promising Long-Term Survival\n\n\n THOUSAND OAKS, Calif.--(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, today announced positive new data for tabelecleucel (tab-cel® or EBVALLO™) in patients with relapsed or refractory (r/r) or treatment-naïve Epstein-Barr virus-positive post-transplant lymphoproliferative disease involving the central nervous system (CNS) (EBV+ CNS PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT). These results will be presented as an oral session at the European Society for Medical Oncology Immuno-Oncology (ESMO I‑O) Annual Congress taking place December 6-8, 2023, in Geneva, Switzerland.\n\n\nThe clinical experience from this combined analysis of four single-arm, open-label studies, including the multicohort Phase 2 EBVision trial (NCT04554914, n=4) expands on previous data from two single-center, Phase 2 studies (NCT00002663, n=10; NCT01498484, n=2), and multicenter, expanded-access protocol (NCT02822495, n=2).\n\n\n“EBV+ CNS PTLD is a rare but extremely serious disease, and patients often face a poor prognosis that underscores the urgent medical need,” said AJ Joshi, M.D., Executive Vice President, Chief Medical Officer at Atara. “We’re pleased to share new multicenter data, including the first results from our ongoing multicohort EBVision trial and first clinical trial report of treatment with tab-cel in the first line setting. Tab-cel shows a strong objective response rate in these high-risk patients with a favorable safety profile for patients with EBV-driven diseases.”\n\n\nIn this pooled analysis, a total of 18 patients, including one previously untreated patient, with EBV+ CNS PTLD received cycles of three weekly infusions of tab-cel at ~2x106 cells/kg. Key endpoints were objective response rate (ORR), overall survival (OS), and safety parameters. Patients received a median (range) of 1 (0 t...