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Atara Biotherapeutics Announces Positive Results from Pivotal Phase 3 Trial (ALLELE) of Tab-cel® at the 63rd American Society of Hematology (ASH) Annual Meeting
Phase 3 ALLELE Study in EBV+ PTLD Demonstrates 50% Objective Response Rate, Consistent with Previous Results At Least 11 of 19 Responders had a Duration of
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nPhase 3 ALLELE Study in EBV+ PTLD Demonstrates 50% Objective Response Rate, Consistent with Previous Results\n\nAt Least 11 of 19 Responders had a Duration of Response (DOR) Lasting More Than Six Months with Median Time to Response in All Patients of Just 1.1 Months\n\nOne-year Survival Rate of 89.2% for Patients Responding to Tab-cel Compared with 32.4% Among Non-Responders\n\n SOUTH SAN FRANCISCO, 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 efficacy and safety results from its Phase 3 multicenter ALLELE study investigating tabelecleucel (tab-cel®) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT). These findings, along with combined long-term survival data from Phase 2 and multicenter Expanded Access Protocol (EAP) studies of tab-cel were featured as oral presentations at the 63rd American Society of Hematology (ASH) Annual Meeting.\n\n“Patients with EBV+ PTLD face a poor prognosis with survival measured in weeks to months if initial treatment is unsuccessful. There are no approved treatment options for this devastating disease, underscoring the critical unmet need that exists,” said Jakob Dupont, MD, Head of Global Research & Development at Atara. “Our conviction that tab-cel, recently filed with the EMA, is a potential first-in-class treatment option for transplant recipients that develop EBV+ PTLD is validated by almost 90% of patients responding to treatment surviving after one year, and a similar two-year survival benefit of over 86% in patients who achieved a complete or partial response from Phase 2 and EAP studies.”\n\nPoor patient survival in relapsed or refractory EBV+ PTLD underscores the significant need for effective, safe, and fast-acting new therapeutic options as highlighted in two additional posters presented at ASH. Patients suffer from poor median survival of 0.7 months (n=81) and 4.1 months (n=86) for HCT and SOT, respectively, reported in EBV+ PTLD patients for whom rituximab ± chemotherapy failed.\n\nIn the ongoing Phase 3 ALLELE study, 38 e...