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

Objective:

To evaluate the efficacy and safety of second-line axicabtagene ciloleucel (axi-cel) in patients with high-risk relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who were ineligible for autologous stem cell transplantation.

Approach:

Study Design: ALYCANTE was a prospective, single-arm, open-label phase 2 study (NCT04531046) conducted at 18 centers. It enrolled adults with high-risk R/R LBCL who were considered ineligible for high-dose chemotherapy and autologous stem cell transplantation.
Patient Treatment: Patients underwent leukapheresis, could receive bridging therapy, and received lymphodepleting chemotherapy before axi-cel at a target dose of 2 × 10^6 CAR T cells/kg.
Endpoints: The primary endpoint was complete metabolic response (CMR) at 3 months. Other reported outcomes included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).

Key Findings:

The CMR rate at 3 months was 71.0% (95% CI, 58.1%–81.8%).
Median PFS was 18.0 months (95% CI, 8.4–35.5); median OS was not reached at the time of analysis.
Among patients who relapsed, 92.9% received subsequent therapy; the best overall response to that therapy was 57.7%.
The cumulative incidence of relapse or progressive disease was 45.2% (95% CI, 32.5%–57.4%).

Interpretation:

In this single-arm study of selected transplant-ineligible patients with high-risk R/R LBCL, second-line axi-cel was associated with responses and survival outcomes reported in the final analysis. The study does not establish comparative efficacy or safety versus other treatments.

Limitations:

The study was small; 62 patients received axi-cel.
Its single-arm design limits comparisons with other treatments.
Findings may not apply to patients who do not meet the study’s eligibility criteria.

Conclusion:

In the ALYCANTE study, patients with high-risk R/R LBCL who were ineligible for transplantation had responses and survival outcomes following second-line axi-cel. These results should be interpreted in light of the study’s size, single-arm design, and selected patient population.