Second-line axicabtagene ciloleucel in large B-cell lymphoma ineligible for transplantation: ALYCANTE final analysis - Scorecard - MDSpire

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

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

At a Glance

Category	Detail
Study	ALYCANTE, a phase 2, multicenter, single-arm study (NCT04531046)
Condition	Relapsed or refractory large B-cell lymphoma (R/R LBCL)
Intervention	Second-line axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 CAR T-cell therapy
Target Population	Adults with high-risk R/R LBCL who were ineligible for high-dose chemotherapy and autologous stem-cell transplantation (HDCT/ASCT)
Primary Endpoint	Complete metabolic response rate at 3 months
Key Results	Complete metabolic response rate, 71.0%; median progression-free survival, 18.0 months; median overall survival, not reached
Safety	Grade ≥3 adverse events occurred in 96.8% of patients; no new safety signals were identified

Key Highlights

71.0% complete metabolic response rate at 3 months
Median progression-free survival of 18.0 months
Median overall survival not reached
96.8% of patients experienced Grade ≥3 adverse events
No new safety signals identified

Guideline-Based Recommendations

Diagnosis

Patients should be assessed for eligibility based on age and comorbidities.

Management

Second-line axi-cel is recommended for patients with high-risk R/R LBCL not eligible for HDCT/ASCT.

Monitoring & Follow-up

Monitor for adverse events and response to treatment post-infusion.

Risks

High incidence of Grade ≥3 adverse events, including neutropenia, anemia, and thrombocytopenia.

Patient & Prescribing Data

Adults aged ≥18 years with high-risk R/R LBCL

Axi-cel treatment resulted in durable responses and prolonged survival without new safety concerns.

Clinical Best Practices

Conduct leukapheresis and lymphodepletion prior to axi-cel infusion.
Consider bridging therapy if necessary before axi-cel administration.
Evaluate patient response and manage adverse events actively.

Related Resources & Content

ALYCANTE Study

Original Source(s)

Hemasphere

Second-line axicabtagene ciloleucel in large B-cell lymphoma ineligible for transplantation: ALYCANTE final analysis

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

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