The New England Journal of MedicineSurvival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma

The phase 3 trial involved 359 patients, with 180 patients receiving axi-cel and 179 patients receiving standard care.

The outcomes of a phase 3 trial regarding the use of axicabtagene ciloleucel (axi-cel) as a second-line treatment for early relapsed or refractory large B-cell lymphoma patients are presented in this study, revealing significant improvements in overall survival and progression-free survival when compared to standard care.

Key Points:

• The median follow-up period was 47.2 months.
• The median overall survival was not reached for the axi-cel group, but was 31.1 months for the standard care group.
• The 4-year overall survival was 54.6% in the axi-cel group and 46.0% in the standard care group (Hazard ratio for death: 0.73, 95% CI: 0.54 to 0.98, P=0.03).
• The median progression-free survival was 14.7 months in the axi-cel group and 3.7 months in the standard-care group, with 4-year percentages of 41.8% and 24.4%, respectively (Hazard ratio: 0.51, 95% CI: 0.38 to 0.67).

Additional Points:

• The trial included 74% of patients with primary refractory disease and other high-risk features.
• No new treatment-related deaths occurred since the primary analysis of event-free survival.

Conclusion:

• Axi-cel as a second-line treatment for early relapsed or refractory large B-cell lymphoma resulted in significantly longer overall survival and progression-free survival compared to standard care, at a median follow-up of 47.2 months.

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Did You Know?
As per the American Cancer Society, non-Hodgkin lymphoma, which includes large B-cell lymphoma, represents approximately 4% of all cancers in the United States.