Safety Advantages of Tab-Cel Over Other T-Cell Therapies in EBV+ PTLD


AJ Joshi, MD, chief medical officer, Atara Biotherapeutics, discussed safety findings from the phase 3 ALLELE study.

Tablecleucel (tab-cel; Atara Biotherapeutics) yielded clinically meaningful improvements in overall response rate (ORR) with promising overall survival (OS) rates in patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD).1,2

These data, from the phase 3 ALLELE study (NCT03394365), were presented at the American Society of Hematology 2021 Meeting, December 11-14, by Susan Prockop, MD, pediatric oncologist/hematologist, program director, Clinical and Translational Research, Boston Children’s Hospital. (Prockop is formerly of Memorial Sloan Kettering [MSK], an ALLELE trial site).

The ALLELE study has enrolled 38 evaluable, heavily pretreated patients with EBV+ PTLD as of May 2021. Independent objective response rate was 50% (95% CI [33.4, 66.6]; n = 19) with tab-cel treatment. Median duration of response is promising but cannot yet be assessed. Investigators observed no new safety signals or concerns, and safety findings were consistent with previously published data.

GeneTherapyLive spoke with AJ Joshi, MD, chief medical officer, Atara Biotherapeutics, to learn more about the safety findings of tab-cel and how they compare to those of other T-cell therapies, including chimeric antigen receptor (CAR) T-cell therapies. He also discussed extended data with tab-cel for up to 20 years from clinical experience at MSK.

For more coverage of ASH 2021, click here.

1. Atara Biotherapeutics to present eight abstracts at the 63rd American Society of Hematology (ASH) Annual Meeting, including first presentation of Tab-cel® pivotal phase 3 (ALLELE) data. News release. Atara Biotherapeutics. November 4, 2021.
2. Prockop S, Mahadeo KM, Beitinjaneh A, et al. Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Recipients with Epstein–Barr Virus-Driven Post Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE). Presented at: 63rd Annual ASH Meeting; December 11-14, 2021, Atlanta, GA. Abstract 301.
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