Atara Biotherapeutics to Present Long-Term Tab-cel™ Phase 2 Clinical Outcomes for Patients with Epstein-Barr Virus Associated Post-Transplant Lymphomas at 23rd Congress of European Hematology Association
“Long-term outcomes including survival, durability of treatment responses and safety continue to highlight the potential compelling benefit of tab-cel™ for patients with EBV-associated lymphomas,” said
Results to be presented at the EHA meeting demonstrate the median survival for tab-cel™ treated patients with EBV+ PTLD following hematopoietic cell transplant (HCT) who failed rituximab was not reached after 23.3 months of follow-up. The expected median survival for patients with EBV+ PTLD following HCT who have failed rituximab first line therapy is 16-56 days.1,2
The median survival for tab-cel™ treated patients with EBV+ PTLD following SOT who failed rituximab was 21.3 months, which compares favorably to the expected 12 to 13-month median survival in patients with EBV+ PTLD following solid organ transplant (SOT) who fail to achieve a complete response to first-line therapy with single-agent rituximab.3 One-year overall survival for patients with EBV+ PTLD following HCT and SOT who failed rituximab was 68 and 64 percent, respectively. Tab‑cel™ was generally well-tolerated with low incidence of treatment-related serious adverse events (SAEs), consistent with previous studies.
Based on the findings from the Phase 2 studies, two Phase 3 clinical studies are underway (MATCH and ALLELE) to evaluate tab-cel™ in patients with EBV+ PTLD who have failed rituximab following HCT or SOT. Results from the first tab-cel™ Phase 3 study and submission of an EU conditional marketing authorization application are expected in the first half of 2019.
The abstract is available in the program section of the EHA Annual Congress website and details for the poster presentation are as follows:
Abstract PF401: Long Term Outcomes of Tabelecleucel (Allogeneic Third-Party EBV-Targeted Cytotoxic T Lymphocytes) for Rituximab-Refractory Post-Transplant EBV+ Lymphomas: A Single Center Experience
Session Title: Gene therapy, cellular immunotherapy and vaccination - Clinical
Presentation Date & Time:
Location: Poster area, Älvsjö building, Stockholm International Fairs and Congress Centre (Stockholmsmässan)
About EBV+ PTLD
Since its discovery as the first human oncovirus, Epstein-Barr virus (EBV) has been implicated in the development of a wide range of lymphoproliferative disorders, including lymphomas, and other cancers. EBV is widespread in all human populations and persists as a lifelong, asymptomatic infection. In immunocompromised patients, such as those undergoing allogeneic hematopoietic cell transplants (HCT) or solid organ transplants (SOT), EBV-associated post-transplant lymphoproliferative disorder (EBV+ PTLD), represents a life-threatening condition. Median overall survival in patients with EBV+ PTLD following HCT who have failed rituximab-based first line therapy is 16-56 days. In EBV+ PTLD following SOT, patients failing rituximab experience increased chemotherapy-induced treatment-related mortality compared to other lymphoma patients. One- and two-year survival in patients with high-risk EBV+ PTLD following SOT is 36% and 0%, respectively.
About tab-cel™ (tabelecleucel; formerly known as ATA129)
Atara's most advanced T-cell immunotherapy in development, tab-cel™, is a potential treatment for patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). In
1Atara estimated 1-year survival based on analysis of Ocheni S, et al. EBV reactivation and post transplant lymphoproliferative disorders following allogeneic SCT. Bone Marrow Transplantation. 2008 Aug;42(3):181-6.
2Fox CP, et al. EBV-associated post-transplant lymphoproliferative disorder following in vivo T-cell-depleted allogeneic transplantation: Clinical features, viral load correlates and prognostic factors in the rituximab era. Bone Marrow Transplant. 2014;49(2):280-6.
3Choquet S, et al. Rituximab in the management of post-transplantation lymphoproliferative disorder after solid organ transplantation: proceed with caution. Ann Hematol. 2007 Aug;86(8):599-607.
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