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Tabelecleucel for EBV+ PTLD after allogeneic HCT or SOT in a multicenter expanded access protocol.
Nikiforow, Sarah; Whangbo, Jennifer S; Reshef, Ran; Tsai, Donald E; Bunin, Nancy; Abu-Arja, Rolla; Mahadeo, Kris Michael; Weng, Wen-Kai; Van Besien, Koen; Loeb, David; Nasta, Sunita Dwivedy; Nemecek, Eneida R; Zhao, Weizhi; Sun, Yan; Galderisi, Faith; Wahlstrom, Justin; Mehta, Aditi; Gamelin, Laurence; Dinavahi, Rajani; Prockop, Susan.
Afiliación
  • Nikiforow S; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
  • Whangbo JS; VOR Bio, Cambridge, MA.
  • Reshef R; Department of Pediatrics, Boston Children's Hospital, Boston, MA.
  • Tsai DE; Blood and Marrow Transplantation and Cell Therapy Program, Columbia University Irving Medical Center, New York, NY.
  • Bunin N; Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
  • Abu-Arja R; Division of Pediatric Hematology/Oncology and Blood and Marrow Transplant, Children's Hospital of Philadelphia, Philadelphia, PA.
  • Mahadeo KM; Division of Pediatric Hematology/Oncology and Blood and Marrow Transplant, Nationwide Children's Hospital, Columbus, OH.
  • Weng WK; Division of Pediatric Transplant and Cellular Therapy, Duke University Medical Center, Durham, NC.
  • Van Besien K; BMT-Cellular Therapy, Department of Medicine, Stanford University, School of Medicine, Stanford, CA.
  • Loeb D; Department of Medicine, University Hospitals Seidman Cancer Center, Cleveland, OH.
  • Nasta SD; Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
  • Nemecek ER; Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
  • Zhao W; Pediatric Transplant & Cellular Therapy, Oregon Health and Science University, Portland, OR.
  • Sun Y; Atara Biotherapeutics, Thousand Oaks, CA.
  • Galderisi F; Atara Biotherapeutics, Thousand Oaks, CA.
  • Wahlstrom J; Atara Biotherapeutics, Thousand Oaks, CA.
  • Mehta A; Atara Biotherapeutics, Thousand Oaks, CA.
  • Gamelin L; Atara Biotherapeutics, Thousand Oaks, CA.
  • Dinavahi R; Atara Biotherapeutics, Thousand Oaks, CA.
  • Prockop S; Atara Biotherapeutics, Thousand Oaks, CA.
Blood Adv ; 8(12): 3001-3012, 2024 Jun 25.
Article en En | MEDLINE | ID: mdl-38625984
ABSTRACT
ABSTRACT Patients with Epstein-Barr virus (EBV)-positive posttransplant lymphoproliferative disease (EBV+ PTLD) in whom initial treatment fails have few options and historically low median overall survival (OS) of 0.7 months after allogeneic hematopoietic cell transplant (HCT) and 4.1 months after solid organ transplant (SOT). Tabelecleucel is an off-the-shelf, allogeneic EBV-specific cytotoxic T-lymphocyte immunotherapy for EBV+ PTLD. Previous single-center experience showed responses in patients with EBV+ PTLD after HCT or SOT. We now report outcomes from a multicenter expanded access protocol in HCT (n = 14) and SOT (n = 12) recipients treated with tabelecleucel for EBV+ PTLD that was relapsed/refractory (R/R) to rituximab with/without chemotherapy. The investigator-assessed objective response rate was 65.4% overall (including 38.5% with a complete and 26.9% with a partial response), 50.0% in HCT, and 83.3% in SOT. The estimated 1- and 2-year OS rates were both 70.0% (95% confidence interval [CI], 46.5-84.7) overall, both 61.5% (95% CI, 30.8-81.8) in HCT, and both 81.5% (95% CI, 43.5-95.1) in SOT (median follow-up 8.2, 2.8, and 22.5 months, respectively). Patients responding to tabelecleucel had higher 1- and 2-year OS rates (94.1%) than nonresponders (0%). Treatment was well tolerated, with no reports of tumor flare, cytokine release syndrome, or rejection of marrow and SOT. Results demonstrate clinically meaningful outcomes across a broad population treated with tabelecleucel, indicating a potentially transformative and accessible treatment advance for R/R EBV+ PTLD after HCT or SOT. This trial was registered at www.ClinicalTrials.gov as #NCT02822495.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante Homólogo / Trasplante de Células Madre Hematopoyéticas / Infecciones por Virus de Epstein-Barr / Trastornos Linfoproliferativos Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Blood Adv Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante Homólogo / Trasplante de Células Madre Hematopoyéticas / Infecciones por Virus de Epstein-Barr / Trastornos Linfoproliferativos Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Blood Adv Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos