Study Finds Axi-Cel Benefits Older Patients With Relapsed or Refractory LBCL


The findings, which suggest that axicabtagene ciloleucel (axi-cel) may be a good option for a patient group often deemed ineligible for other curative-intent therapy, come from a planned subgroup analysis from the ZUMA-7 trial.

Axicabtagene ciloleucel (axi-cel; sold as Yescarta) showed longer event-free survival (EFS) and higher response rates in patients ages 65 and older with relapsed or refractory large B-cell lymphoma (R/R LBCL), according to a newly released subgroup analysis from the ZUMA-7 trial.

The results suggest the therapy may be a good option for a patient group often deemed ineligible for other curative-intent therapy.

Writing in the journal Clinical Cancer Research, corresponding author Jason R. Westin, MD, MS, of MD Anderson Cancer Center, and colleagues, said older patients with LBCL have limited treatment options.

“Historically, patients were frequently deemed transplant-ineligible based upon age due to an inability to tolerate the toxicities of high-dose chemotherapy, and recommended therapies for older patients were described as palliative with a very poor chance of long-term disease control,” they wrote.

In relapsed or refractory cases, the second-line standard-of-care chemotherapy-based treatment can be intolerable for patients and reportedly leads to worse outcomes and a higher risk of toxicities.

“Considering the median age of LBCL diagnosis is 66 years, there remains a large unmet need for effective and tolerable curative-intent therapies in older patients with R/R LBCL,” they wrote.

One possible solution is axi-cel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy that has been approved for adults with R/R LBCL after at least 2 lines of systemic therapy, the authors said.

In the phase III ZUMA-7 trial, axi-cel outperformed standard-of-care therapy in patients who were refractory to first-line therapy or had relapsed less than 12 months after completing first-line chemoimmunotherapy. In that trial, the axi-cel group had a median EFS of 8.3 months versus 2.0 months for patients receiving standard-of-care therapy. It also led to improved quality of life (QOL) versus standard treatment, the authors found.

The new report is a preplanned subgroup analysis looking at patients in the trial who were at least 65 years old. Within the subgroup, 51 patients were randomized to receive axi-cel, and 57 patients were randomized to the standard-of-care therapy (2-3 cycles of chemoimmunotherapy followed by high-dose chemotherapy with autologous stem-cell transplantation).

At a median follow-up of 24.3 months, Westin and colleagues found that the axi-cel group had a median EFS of 21.5 months compared with 2.5 months in the standard-of-care group. Axi-cel had an objective response rate of 88%, compared with 52% in the control group. In terms of QOL, axi-cel led to improved scores at both 100 days and 150 days.

Ninety-four percent of patients in the axi-cel group had grade 3 or above adverse events, compared with 82% in the standard-of-care group, though no grade-5 cytokine release syndrome or neurologic events occurred, the authors said.

“Thus, we demonstrate that axi-cel is both feasible and effective in patients ≥65 years with R/R LBCL after first-line therapy, establishing a new SOC therapeutic option,” the authors said.

Westin and colleagues noted that there was a 100% CAR T-cell manufacturing success rate in ZUMA-7, including the 65-and-older subgroup.

“Our results clearly demonstrate that older patients can safely receive second-line therapy with axi-cel, and together with the superior efficacy and improvements in QOL that were observed (compared with SOC [standard-of-care]), these data suggest that axi-cel should be considered as second-line therapy for patients ≥65 with R/R LBCL,” Westin and colleagues concluded.


Westin JR, Locke FL, Dickinson M, et al. Safety and Efficacy of Axicabtagene Ciloleucel versus Standard of Care in Patients 65 Years of Age or Older with Relapsed/Refractory Large B-Cell Lymphoma. Clin Cancer Res. 2023;29(10):1894-1905. doi:10.1158/1078-0432.CCR-22-3136

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