Axicabtagene ciloleucel as second-line therapy in large B cell lymphoma ineligible for autologous stem cell transplantation: a phase 2 trial - Centre Eugène Marquis Access content directly
Journal Articles Nature Medicine Year : 2023

Axicabtagene ciloleucel as second-line therapy in large B cell lymphoma ineligible for autologous stem cell transplantation: a phase 2 trial

François-Xavier Gros
Lucie Oberic
  • Function : Author
Thomas Gastinne
  • Function : Author
Catherine Thieblemont
Magalie Joris
  • Function : Author
Fabrice Jardin
Sylvain Choquet
Gabriel Brisou
  • Function : Author
Jacques-Olivier Bay
  • Function : Author
Marie-Hélène Delfau
  • Function : Author
Emmanuel Itti
  • Function : Author
Yassine Al Tabaa
  • Function : Author

Abstract

Abstract Axicabtagene ciloleucel (axi-cel) demonstrated superior efficacy compared to standard of care as second-line therapy in patients with high-risk relapsed/refractory (R/R) large B cell lymphoma (LBCL) considered eligible for autologous stem cell transplantation (ASCT); however, in clinical practice, roughly half of patients with R/R LBCL are deemed unsuitable candidates for ASCT. The efficacy of axi-cel remains to be ascertained in transplant-ineligible patients. ALYCANTE, an open-label, phase 2 study, evaluated axi-cel as a second-line therapy in 62 patients with R/R LBCL who were considered ineligible for ASCT. The primary end point was investigator-assessed complete metabolic response at 3 months from the axi-cel infusion. Key secondary end points included progression-free survival, overall survival and safety. The study met its primary end point with a complete metabolic response of 71.0% (95% confidence interval, 58.1–81.8%) at 3 months. With a median follow-up of 12.0 months (range, 2.1–17.9), median progression-free survival was 11.8 months (95% confidence interval, 8.4–not reached) and overall survival was not reached. There was no unexpected toxicity. Grade 3–4 cytokine release syndrome and neurologic events occurred in 8.1% and 14.5% of patients, respectively. These results support axi-cel as second-line therapy in patients with R/R LBCL ineligible for ASCT. ClinicalTrials.gov Identifier: NCT04531046 .
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hal-04212634 , version 1 (15-11-2023)

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Roch Houot, Emmanuel Bachy, Guillaume Cartron, François-Xavier Gros, Franck Morschhauser, et al.. Axicabtagene ciloleucel as second-line therapy in large B cell lymphoma ineligible for autologous stem cell transplantation: a phase 2 trial. Nature Medicine, 2023, ⟨10.1038/s41591-023-02572-5⟩. ⟨hal-04212634⟩
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