Dr Leslie on the Clinical Benefit of Axi-Cel in Elderly Patients With R/R LBCL

Lori A. Leslie, MD, director, Indolent Lymphoma and Chronic Lymphocytic Leukemia Research Programs, John Theurer Cancer Center, assistant professor, Hackensack Meridian School of Medicine, discusses the efficacy and safety of second-line axicabtagene ciloleucel (Yescarta; axi-cel) in elderly patients with high-risk, relapsed/refractory large B-cell lymphoma (LBCL).

At the 2023 ASH Annual Meeting, investigators presented findings from a subgroup analysis of patients 65 years of age or older from the phase 3 ZUMA-7 trial (NCT03391466), Leslie begins. In this global trial, patients who had refractory LBCL and had relapsed within 12 months after initial chemoimmunotherapy were randomly assigned 1:1 to treatment with axi-cel or conventional therapy. In the standard-of-care (SOC) arm, patients who responded to chemoimmunotherapy subsequently underwent treatment with high-dose chemotherapy with autologous stem cell transplantation.

Results demonstrated that axi-cel produced statistically significant and clinically meaningful benefits in overall survival (OS) and progression-free survival (PFS) vs SOC treatment in this population, Leslie reports. Overall, patients treated with axi-cel experienced a median OS of43.5 months (95% CI; 20.9-not evaluable [NE]) compared with 19.5 months (95% CI; 12.3-NE) in the SOC arm (HR, 0.691; 95% CI, 0.401-1.190). Moreover, the median OS with axi-cel in patients aged 70 years or older was 24.7 months (95% CI; 12.8-NE) vs 11.2 months (95% CI; 6.1-NE) with the SOC (HR, 0.330; 95% CI, 0.135-0.809).

Similarly, the median PFS in patients 65 years of age or older was 28.6 months (95% CI; 5.1-NE) with axi-cel and 5.0 months (95% CI; 2.8-7.3) with the SOC (HR, 0.406; 95% CI, 0.230-0.715). In patients 70 year of age or older, axi-cel elicited a median OS of 11.4 months (95% CI; 4.1-NE), and the SOC produced a median OS of 2.7 months (95% CI; 1.7-5.0; HR, 0.206; 95% CI, 0.078-0.547).

These findings indicate that axi-cel should be considered as an intensive and potentially curative second-line therapeutic option for patients with relapsed/refractory LBCL regardless of age, Leslie concludes.