Final Analysis of Second-Line Axicabtagene Ciloleucel for Large B-Cell Lymphoma Patients Not Eligible for Transplantation: ALYCANTE Study Results

By
Roch Houot
Jean Lemoine
Alexis Claudel
Emmanuel Bachy
Guillaume Cartron
François-Xavier Gros
Franck Morschhauser
Lucie Oberic
Thomas Gastinne
Pierre Feugier
Rémy Duléry
Catherine Thieblemont
Magalie Joris
Fabrice Jardin
Sylvain Choquet
Olivier Casasnovas
Gabriel Brisou
Morgane Cheminant
Jacques-Olivier Bay
Jules Coville
Francisco Llamas-Gutierrez
Karin Tarte
Cédric Portugues
Emmanuel Itti
Xavier Palard-Novello
Paul Blanc-Durand
Yassine Al Tabaa
Clément Bailly
Camille Laurent
François Lemonnier
September 22, 2026

Hemasphere

Overview

The final analysis of the ALYCANTE study reports a 71.0% complete metabolic response rate at 3 months and a median progression-free survival of 18.0 months in patients with high-risk relapsed/refractory large B-cell lymphoma who are ineligible for transplantation.

Background

Axicabtagene ciloleucel is a CAR T-cell therapy that has been evaluated as a second-line treatment for patients with refractory/relapsed large B-cell lymphoma. Many patients are ineligible for transplantation due to age or comorbidities, making effective alternative therapies critical. The ALYCANTE trial specifically addresses the treatment of this high-risk population.

Data Highlights

Outcome	Result	95% Confidence Interval
3-month Complete Metabolic Response Rate	71.0%	58.1%–81.8%
Overall Response Rate	90.3%	81.8%−95.7%
Cumulative Incidence of Relapse/Progressive Disease	45.2%	32.5%–57.4%
3-year Progression-Free Survival	37.3%	25.0%−49.5%
3-year Overall Survival	55.9%	42.6%−67.3%

Key Findings

71.0% complete metabolic response rate at 3 months.
90.3% overall response rate among patients treated with axi-cel.
Median progression-free survival of 18.0 months.
3-year overall survival estimate of 55.9%.
45.2% cumulative incidence of relapse or progressive disease post-treatment.

Clinical Implications

The findings from the ALYCANTE study provide data on the use of axicabtagene ciloleucel in patients with high-risk relapsed/refractory large B-cell lymphoma who are not candidates for transplantation.

Conclusion

The authors concluded that axicabtagene ciloleucel demonstrated durable efficacy in transplant-ineligible patients with relapsed or refractory large B-cell lymphoma, supporting its use as a second-line treatment option for this high-risk population.

Related Resources & Content

Locke FL, et al., The New England Journal of Medicine, 2022 -- Axicabtagene Ciloleucel vs Standard of Care as Second-Line Treatment for Large B-cell Lymphoma
FDA Approves Axicabtagene Ciloleucel for the Second-Line Treatment of Large B-Cell Lymphoma, The ASCO Post, 2022
Overall Survival With Axicabtagene Ciloleucel in Large B-Cell Lymphoma: Results From ZUMA-7, The ASCO Post, 2023
The ASCO Post — Axicabtagene Ciloleucel vs Standard of Care as Second-Line Treatment for Large B-cell Lymphoma
The ASCO Post — FDA Approves Axicabtagene Ciloleucel for the Second-Line Treatment of Large B-Cell Lymphoma
ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
Axicabtagene ciloleucel as second-line therapy in large B cell lymphoma ineligible for autologous stem cell transplantation: a phase 2 trial
Survival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma | New England Journal of Medicine