Atara Biotherapeutics and Pierre Fabre Laboratories Publish Data from Phase 3 ALLELE Tab-cel® Trial in The Lancet Oncology”
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, and Pierre Fabre Laboratories, a global player in oncology responsible for the worldwide commercialization of tabelecleucel (tab-cel® or EBVALLO™), jointly announced the online publication of data from the pivotal Phase 3 ALLELE study of tab-cel. The European Union (EU) has approved tab-cel for 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).
The Lancet Oncology released 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.” The results showcased the clinical value of tab-cel, marking it as a groundbreaking treatment for a devastating disease that lacked adequate therapeutic options. The data demonstrated a 51.2% objective response rate (ORR), with responders experiencing longer survival compared to non-responders.
The ALLELE study’s success paved the way for tab-cel’s approval by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the EU. Pascal Touchon, President and CEO of Atara, expressed enthusiasm about the results, emphasizing their commitment to obtaining U.S. Food and Drug Administration (FDA) approval through a biologics license application (BLA) submission in the second quarter of 2024.
The publication highlighted the favorable safety profile of tab-cel, with no significant adverse events reported. The data further supported the drug’s effectiveness, with a statistically significant 49% ORR in a subsequent analysis from October 2023, reinforcing its potential for the U.S. market.
Susan Prockop, MD, lead investigator at Boston Children’s Hospital-Dana Farber Cancer Institute, emphasized the clinical significance of tabelecleucel, addressing the urgent unmet medical need for patients with limited treatment options and poor overall survival.
Tab-cel, granted marketing authorization as EBVALLO™ in the EU, represents a breakthrough in allogeneic T-cell therapy, providing hope for patients and aligning with Pierre Fabre Laboratories’ commitment to making a positive impact on individuals and families. The collaboration between Atara and Pierre Fabre marks a transformative milestone in the treatment landscape for r/r EBV+ PTLD, reinforcing the innovative nature of tab-cel.
