On January 31, 2024 Atara 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, and Pierre Fabre Laboratories, a global player in oncology and responsible for worldwide commercialization of tabelecleucel (tab-cel or EBVALLO), reported that data from the pivotal Phase 3 ALLELE study of tab-cel, approved in the European Union in adults and children two years of age and older 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), were published for the first time online in The Lancet Oncology (Press release, Atara Biotherapeutics, JAN 31, 2024, View Source [SID1234639761]).
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The data were published in an article titled, "Tabelecleucel for allogeneic haematopoietic stem-cell or solid organ transplant recipients with Epstein–Barr virus-positive post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE): a phase 3, multicentre, open-label trial," and can be accessed at the following link: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00649-6/fulltext
"The results of the ALLELE study highlight the clinical value of tab-cel, which is now EMA and MHRA approved, and is being made available to patients in Europe through our partner Pierre Fabre Laboratories as a first-of-its-kind treatment for those with a devastating disease that previously had limited treatment options," said Pascal Touchon, President and Chief Executive Officer of Atara. "As we prepare for our tab-cel BLA submission in the second quarter 2024, we look forward to interacting with the FDA to progress towards approval based on our robust clinical data."
As reported in The Lancet Oncology publication, the ALLELE study met its primary endpoint. 22 of 43 EBV+ PTLD patients achieved an objective response (51.2% objective response rate, or ORR). Those that responded to tab-cel had longer survival, with an estimated one-year overall survival of 84.4% (95% CI: 58.9, 94.7) for responders versus 34.8% (95% CI: 14.6, 56.1) for non-responders. The median duration of response was 23.0 months and the median overall survival was 18.4 months. Tab-cel was well tolerated with no reports of tumor flare reaction, cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome, and no events of graft-versus-host disease or SOT rejection as related to tab-cel. These interim data were previously presented at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
These pivotal trial data are supported by a recent updated analysis from the October 2023 data cut of the ongoing ALLELE study that continued to demonstrate a statistically significant 49% ORR (p<0.0001), consistent durability of response, estimated OS, and favorable safety profile in the intended population for the proposed U.S. label. ln addition, real-world results from the multicenter Expanded Access Program study in Europe demonstrated an ORR of 66.7% in 24 EBV+ PTLD patients and were presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
"Patients with relapsed or refractory EBV+ PTLD have limited treatment options and poor overall survival measured in only weeks to months," said Susan Prockop, MD, lead investigator, Boston Children’s Hospital-Dana Farber Cancer Institute. "These clinically meaningful data reinforce the life-saving potential of tabelecleucel for these patients, for whom there are no approved therapies in the U.S. and helps address an urgent unmet medical need."
Tab-cel was granted marketing authorization under the brand name EBVALLO in December 2022 by the European Commission (EC) as a monotherapy for the treatment of adult and pediatric patients two years of age and older with r/r EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. In the United States, Atara plans to submit a biologics license application (BLA) to the U.S. Food and Drug Administration for tab-cel for the treatment of EBV+ PTLD in the second quarter of 2024. Additionally, in December 2023, Atara reported the first results from the ongoing Phase 2 EBVision trial, which has the potential to further extend the clinical experience and potential of tab-cel into broader indications.
In December 2023, Atara announced the closing of the expanded global partnership with Pierre Fabre Laboratories for the U.S. and remaining global commercial markets for tabelecleucel, building on an initial partnership covering Europe, Middle East, Africa, and other select emerging markets.
"Current results from the first global, multicenter, open-label Phase 3 study of the new allogeneic T-cell therapy, tabelecleucel, show significant clinical benefit and a favorable safety profile in a severely affected population. These results bring a lot of hope for patients, and confirm the innovative nature of this treatment, also recognized through the Prix Galien prize that we received in France. With the recent EU marketing authorization, EBVALLO is the first EBV-specific allogeneic T-cell therapy available for patients with r/r EBV+ PTLD after HCT or SOT and their families. All this resonates perfectly with our purpose ‘every time we care for a single person, we make the whole world better,’" said Núria Perez-Cullell, Director of Medical Affairs, Patients & Consumers at Pierre Fabre Laboratories.