Atara Biotherapeutics and Pierre Fabre Laboratories Announce Publication of Phase 3 ALLELE Tab-cel Data in The Lancet Oncology - Seite 2

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) 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.