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Atara Biotherapeutics Presents Updated Tab-cel® Clinical Effectiveness Data at ASCO 2023
Real-World Results Demonstrate Objective Response Rate (ORR) of 67% in 24 EBV+ PTLD Patients 91% Overall Survival (OS) at One Year for Patients Responding to
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nReal-World Results Demonstrate Objective Response Rate (ORR) of 67% in 24 EBV+ PTLD Patients\n\n\n91% Overall Survival (OS) at One Year for Patients Responding to Tab-cel Compared to 34% for Non-Responders\n\n\nTab-cel Safety Profile Consistent with Phase 3 ALLELE Study Findings\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 updated effectiveness and safety data for tabelecleucel (tab-cel® or EBVALLO™) from the multicenter Expanded Access Program (EAP) study in Europe. The results will be featured in a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago.\n\n\nAtara supported 27 EAP requests in Europe for patients 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). 24 EBV+ PTLD patients, 16 SOT recipients and eight HCT recipients, consented to use of data and received at least one dose of tab-cel, including four patients with EBV+ primary central nervous system (PCNS) PTLD.\n\n\nAn objective response rate (ORR) of 66.7% (16/24) was observed for both SOT and HCT groups (95% CI: 44.7, 84.4), 56.3% (9/16) for patients following SOT (95% CI: 29.9, 80.2) and 87.5% (7/8) for HCT patients (95% CI: 47.3, 99.7) with a best overall response of Complete Response (CR; 33.3%; n=4, SOT, n=4, HCT) or Partial Response (PR; 33.3%; n=5, SOT, n=3, HCT).\n\n\n\"These real-world results affirm the favorable risk-benefit profile seen in the pivotal Phase 3 ALLELE study which supported tab-cel as the first-ever allogeneic T-cell immunotherapy approved,\" said AJ Joshi, MD, Chief Medical Officer at Atara. \"Tab-cel was well tolerated and delivered a one-year survival rate of nearly 91% in responders, reinforcing its potential to address an urgent unmet medical need for EBV+ PTLD patients.”\n\n\nThe median time to response (TTR) in all patients was 1.0 month (range: 0.8–2.2). Of the subgroup of patients with EBV+ PCNS PTLD, three out of four (75%; 95% CI: 19.4, 99.4) treated patients achie...