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

2023; Nature Portfolio; Volume: 29; Issue: 10 Linguagem: Inglês

10.1038/s41591-023-02572-5

1546-170X

Roch Houot, Emmanuel Bachy, Guillaume Cartron, François‐Xavier Gros, Franck Morschhauser, Lucie Obéric, Thomas Gastinne, Pierre Feugier, Rémy Duléry, Catherine Thiéblemont, Magalie Joris, Fabrice Jardin, Sylvain Choquet, Olivier Casasnovas, Gabriel Brisou, Morgane Cheminant, Jacques‐Olivier Bay, Francisco Llamas Gutierrez, Cédric Menard, Karin Tarte, Marie-Hélène Delfau, Cédric Portugues, Emmanuel Itti, Xavier Palard-Novello, Paul Blanc‐Durand, Yassine Al Tabaa, Clément Bailly, Camille Laurent, François Lemonnier,

Immune Cell Function and Interaction

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 .