Atara Submits BLA for Tab-Cel EBV+ PTLD T-Cell Therapy
Tab-Cel is approved under the name Ebvallo in Europe, Switzerland, and United Kingdom.
Atara Biotherapeutics has submitted a biologics license application (BLA) for tabelecleucel (tab-cel) monotherapy for treating adult and pediatric patients 2 years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least 1 prior therapy.1
“The BLA submission for tab-cel represents a significant moment for Atara, our partner Pierre Fabre, and the broader allogeneic T-cell therapy field, and is a critical step towards our goal of delivering this first-of-its-kind treatment to EBV+ PTLD patients in the US,” Pascal Touchon, President and Chief Executive Officer, Atara, said in a statement.1 “I would like to thank the patients and physicians who participated in the tab-cel clinical trials, our long-time collaborators at Memorial Sloan Kettering Cancer Center, as well as our internal teams for their remarkable dedication and hard work. We now look forward to continued collaboration with the FDA on its review and with Pierre Fabre as they actively prepare for the potential launch of this innovative therapy in the US.”
Tab-cel is an allogeneic T-cell therapy that targets EBV-infected cells and is approved under the name Ebvallo for this indication in Europe, the United Kingdom, and Switzerland. The BLA submission is supported by data from the pivotal ALLELE study. Data from ALLELE were presented by Amer Beitinjaneh, MD, MSc, MPH, FACP, associate professor of medicine at Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, at the 2023 Tandem Meetings |Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR.
The trial treated 43 patients who had EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT) or solid organ transplant (SOT), and for whom treatment with rituximab or rituximab and chemotherapy was not effective. The updated data demonstrated a statistically significant 48.8% objective response rate (ORR) (P <.0001) with tab-cel treatment, with a favorable and consistent safety profile.2 Complete response rates were 27.9% across all treated patients, 42.9% for patients after hematopoietic stem cell transplant, and 20.7% for patients after solid organ transplant.2
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“For patients with EBV-positive Post-Transplant Lymphoproliferative Disorder who failed rituximab-based therapy, the outcome is usually very dismal... Median overall survival is often less than 4 months and there are currently no approved treatments indicated for those patients. So initially, we will use immune suppression and rituximab-based therapy, but once you fail, you will pretty much have no option,” Beitinjaneh told CGTLive at the Tandem meeting.
Atara previously announced its plans to submit a BLA for tab-cel in the beginning of the year, while also announcing that it was discontinuing its phase 2 EMBOLD trial (NCT03283826) of ATA188, its other allogeneic, EBV T-cell immunotherapy intended for treating multiple sclerosis, after it failed its primary endpoint of showing superiority over placebo.3
REFERENCES
1. Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA. News release. Atara Biotherapeutics. May 20, 2024. https://www.businesswire.com/news/home/20240520985176/en/Atara-Biotherapeutics-Submits-Tabelecleucel-Tab-cel%C2%AE-Biologics-License-Application-for-Treatment-of-Epstein-Barr-Virus-Positive-Post-Transplant-Lymphoproliferative-Disease-with-U.S.-FDA
2. Beitinjaneh A, Baiocchi R, Choquet S, et al. New and updated results from a multicenter, open-label, global phase 3 (P3) study of tabelecleucel (Tab-cel) for Epstein–Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) following allogeneic hematopoietic cell (HCT) or solid organ transplant (SOT) after failure of rituximab (R) or rituximab and chemotherapy (R+CT) (ALLELE). Presented at: 2023 Tandem Meetings, February 15-19, 2023; Orlando, Florida. Abstract #25.
3. Atara Biotherapeutics to present recent progress and key upcoming milestones at the 42nd annual J. P. Morgan healthcare conference. News release. Atara Biotherapeutics. January 8, 2024. https://investors.atarabio.com/news-events/press-releases/detail/333/atara-biotherapeutics-to-present-positive-new-tab-cel
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