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Two-year follow-up of TRANSCEND NHL 001 suggests lisocabtagene maraleucel maintains a durable response in R/R large B-cell lymphoma

Apr 27, 2022
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Learning objective: After reading this article, learners will be able to cite a new clinical development in lymphoma/CLL

Follow-up data obtained from the TRANSCEND NHL 001 trial (NCT02631044) demonstrates that treatment with lisocabtagene maraleucel (liso-cel) leads to long-lasting responses in patients with relapsed/refractory large B-cell lymphoma. Below, we summarize the data as presented at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR[MM1] .1

Liso-cel is an autologous, CD19-directed, defined composition, 4-1BB chimeric antigen receptor (CAR) T-cell product administered at equal target doses of CD8+ and CD4+ T cells. The therapy was recently approved by the European Commission as a ≥third-line treatment for certain forms of relapsed or refractory large B-cell lymphoma.

Key data

At the 2-year follow-up, the TRANSCEND NHL 001 study met all of its primary and secondary endpoints.

Efficacy

Of the 269 patients who received liso-cel, 257 were evaluable for efficacy:

  • 73% overall response rate;
  • 53% complete response rate;
  • median duration of response was 23.1 months for patients who achieved partial response and 26.1 months for those who achieved complete response;
  • median progression-free survival was 6.8 months;
  • median overall survival was 27.3 months;
  • estimated 2-year duration of response, progression-free survival, and overall survival were 49.5%, 40.6%, and 50.5%, respectively; and
  • CAR T-cells were detectable in peripheral blood for up to 4 years.

Safety

  • Cytokine release syndrome and neurological events of any grade occurred in 42% and 30% of patients, with a median time to onset of 5 and 9 days, respectfully.
  • The most common adverse events within 90 days of infusion were neutropenia (63%), anemia (48%), and fatigue (44%).
  • The most frequently reported ≥Grade 3 adverse events were neutropenia (7%), anemia (6%), febrile neutropenia (4%), and thrombocytopenia (4%).
  • ≥Grade 3 infections occurred in 12% of patients.
  • In total, 100 patients died in the post treatment-emergent period; disease progression was responsible in 86%.

In conclusion, liso-cel demonstrated durable remission rates and a promising safety profile in the 2-year follow-up of TRANSCEND NHL 001. Treatment was associated with a low incidence of severe cytokine release syndrome and neurological events. There were no additional safety concerns observed in this follow-up, and most of the adverse events occurred in the treatment-emergent reporting period.

  1. Abramson JS, Palomba LM, Gordon LI, et al. Two-year follow-up (FU) of transcend NHL 001, a multicenter phase 1 study of lisocabtagene maraleucel (liso-cel) in relapsed or refractory (R/R) large B-cell lymphomas (LBCL). Abstract #65. Presented at: 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR; Apr 24, 2022; Virtual.

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