On May 17, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that the Company and its collaborating investigators at Memorial Sloan Kettering Cancer Center (MSK) will present long-term clinical outcomes for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who failed first line treatment and were subsequently treated with tab-cel (tabelecleucel) in Phase 2 studies (Press release, Atara Biotherapeutics, MAY 17, 2018, View Source [SID1234526755]). The poster will be featured during the upcoming 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), which will be held in Stockholm, Sweden, June 14-17, 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 Dietmar Berger, M.D., Ph.D., Global Head of Research and Development of Atara Biotherapeutics. "Under the current standard of care, EBV+ PTLD is an aggressive cancer that often rapidly progresses to death after diagnosis. We remain focused on advancing our late-stage clinical development and working closely with global health authorities to bring tab‑cel to patients with this life-threatening disease as expeditiously as possible."

Results to be presented at the EHA (Free EHA Whitepaper) 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 (Free EHA Whitepaper) 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: Friday, June 15; 5:30 p.m. to 7:00 p.m. CEST
Authors:Susan Prockop, Ekaterina Doubrovina, Amy Feng, Guenther Koehne, Parastoo Dahi, Esperanza Papadopoulos, Craig Sauter, Stephanie Suser, Willis Navarro, Akshay Sudhindra, Richard O’Reilly
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 February 2015, FDA granted tab-cel Breakthrough Therapy Designation for EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT), and in October 2016, tab-cel was accepted into the EMA Priority Medicines (PRIME) regulatory pathway for the same indication, providing enhanced regulatory support. Atara also received positive regulatory feedback from Health Canada in September 2017 supporting the submission of tab-cel for an expedited approval pathway. In addition, tab-cel has orphan status in the U.S. and EU. Tab-cel is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study), and Atara is planning a Phase 1/2 study in NPC. Tab-cel is also available to eligible patients with EBV-associated hematologic and solid tumors through an ongoing multicenter expanded access protocol clinical study, positive interim results of which were presented in December 2017 at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.