Yescarta Improves Survival for Patients With Large B-Cell Lymphoma

Yescarta (axicabtagene ciloleucel) showed an improvement in overall survival (OS; the time a patient lives following treatment regardless of disease status) and progression free survival (PFS, the time a patient lives without their disease worsening) in patients 65 and older with large B-cell lymphoma who previously underwent one line of therapy compared with standard of care, according to subgroup findings from the phase 3 ZUMA-7 trial presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition.

In the subgroup of patients 65 and older, the median OS in those receiving Yescarta versus standard of care was 43.5 months and 19.5 months, respectively. In the subgroup of patients 70 and older, the median OS in patients receiving Yescarta versus standard of care was 24.7 months and 11.2 months, respectively.

In the subgroup of patients 65 and older, the median PFS in patients receiving Yescarta versus standard of care was 28.6 months and five months, respectively. In the subgroup of patients 70 and older, the median OS in each arm was 11.4 months and 2.7 months, respectively.

“In the subgroup analysis, (Yescarta) as second-line therapy showed prolonged survival over standard of care in patients aged 65 years or older, including in patients aged 70 years or older,” said presenting author Dr. Marie José Kersten, professor of hematology at Amsterdam University Medical Centers. “These findings confirm that age alone should not be a barrier for consideration of CAR-T cell therapy and support the use of (Yescarta) as a curative intense second-line therapeutic option for elderly patients with relapsed refractory large B-cell lymphoma.”

In the international phase 3 trial, patients with refractory large B-cell lymphoma or who had relapsed no more than 12 months after first-line chemoimmunotherapy were randomly assigned to receive Yescarta or standard care, followed by high-dose chemotherapy with autologous stem-cell transplantation in patients with a response to the chemoimmunotherapy.Patients were able to receive cellular immunotherapy if they did not experience a response to standard of care. A total of 109 patients 65 and older were included in the subgroup analysis.

The primary endpoint of the study was event-free survival (EFS; the time a patient lives without complications from their disease). Secondary endpoints included OS, PFS and safety.

Improved OS in patients 65 years and older who received Yescarta was also associated with a greater proportion of naive T cells.

Any-grade and grade 3 or higher side effects of interest in the experimental arm versus control arm, respectively, were cytokine release syndrome (CRS, a systemic inflammatory response; 98% and 8% versus not evaluable), neurological events (67% and 27% versus 25% and 2%), hypogammaglobulinemia (low immunoglobin levels, 20% and 0% versus 2% and 0%), cytopenia (reduced blood cell counts, 84% and 84% versus 82% and 76%) and infections (61% and 29% versus 38% and 16%).

Death occurred in 51% of patients receiving Yescarta and 53% of patients receiving standard of care. Reasons for death included progressive disease (41% versus 36%), grade 5 side effects (4% versus 2%), new or secondary malignancies (2% versus 0%) and definitive therapy-related mortality (0% versus 2%).

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