Long-Term Outcomes of Patients with Epstein-barr Virus-Driven Post-Transplant Lymphoproliferative Disease Following Solid Organ Transplant or Allogeneic Hematopoietic Cell Transplant Treated with Tabelecleucel in an Expanded Access Program Study
1Memorial Sloan Kettering Cancer Center, New York, NY, 2Columbia University Irving Medical Center, New York, NY, 3Loxo Oncology, Stamford, CT, 4The Children's Hospital of Philadelphia, Philadelphia, PA, 5Nationwide Children's Hospital, Columbus, OH, 6MD Anderson Cancer Center, Houston, TX, 7Stanford University School of Medicine, California, CA, 8Weill Cornell Medical College, New York, NY, 9Children's Hospital at Montefiore, Bronx, NY, 10University of Pennsylvania, Philadelphia, PA, 11Oregon Health & Science University, Portland, OR, 12Atara Biotherapeutics, New York, NY, 13Dana Farber Cancer Institute, Boston, MA
Meeting: 2020 American Transplant Congress
Abstract number: 501
Keywords: Epstein-Barr virus (EBV), Post-transplant lymphoproliferative disorder (PTLD)
Session Information
Session Time: 3:15pm-4:45pm
Presentation Time: 3:51pm-4:03pm
Location: Virtual
*Purpose: There is a need for effective, well‑tolerated therapies in pts who develop Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) after solid organ (SOT) or allogeneic hematopoietic cell transplant (HCT) and have failed rituximab ± chemotherapy (CT). Tabelecleucel (tab-cel) is an investigational, off-the-shelf, allogeneic EBV-specific T-cell immunotherapy generated from healthy donors. Here, we report long-term outcomes using tab-cel in an ongoing US, multicenter EAP study (EBV-CTL-201, NCT02822495) in pts with relapsed/refractory (R/R) EBV+ PTLD.
*Methods: In each 5-week cycle, pts received tab-cel 1.6-2 x 106 cells/kg IV on days 1, 8, and 15, with assessment around day 28. Pts were treated until maximal response, unacceptable toxicity, or withdrawal of consent.
*Results: As of June 3, 2019, 26 EBV+ PTLD pts were treated (HCT: n=14; SOT: n=12). All pts received prior rituximab and 7/12 SOT pts received prior CT. Intermediate/high risk PTLD prognostic index was noted in 79% and 42% of HCT and SOT pts. The ORR was 50% and 83%, and the 2-year OS was 60% and 83% in the HCT and SOT cohorts. Median follow-up time was 3 (range 1-25) and 15 (range 3-25) months in HCT and SOT cohorts, respectively. In pts responding to tab-cel, 1-year OS was 85.7% in HCT and 100% in SOT, with no deaths attributed to EBV+ PTLD progression. In a subset of pts (HCT: n=11; SOT: n=11), who may have potentially been eligible for ongoing Phase 3 tab-cel studies based on adequate ECOG, and no CNS disease or PTLD-related ventilatory support, the ORR was 55% (HCT) and 82% (SOT). The safety profile of tab-cel was well-tolerated and consistent with previously reported data.
*Conclusions: The data demonstrate a high response rate for tab-cel in EBV+ PTLD in both HCT and SOT after initial treatment failure. Long-term follow-up shows favorable survival outcomes in this mostly high-risk population for whom there are no approved alternative therapies. Similar outcomes were observed in the subset of pts potentially eligible for ongoing Phase 3 studies of tab-cel in R/R EBV+ PTLD following SOT or HCT.
To cite this abstract in AMA style:
Prockop S, Reshaf R, Tsai D, Bunin N, Abu-Arja R, Mahadeo K, Weng W, Besien KVan, Loeb D, Nasta SDwivedy, Nemecek E, Hiremath M, Yue S, Sun Y, Navarro W, Nikiforow S. Long-Term Outcomes of Patients with Epstein-barr Virus-Driven Post-Transplant Lymphoproliferative Disease Following Solid Organ Transplant or Allogeneic Hematopoietic Cell Transplant Treated with Tabelecleucel in an Expanded Access Program Study [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/long-term-outcomes-of-patients-with-epstein-barr-virus-driven-post-transplant-lymphoproliferative-disease-following-solid-organ-transplant-or-allogeneic-hematopoietic-cell-transplant-treated-with-tabe/. Accessed November 21, 2024.« Back to 2020 American Transplant Congress