Real-World Outcomes of Axi-cel versus CIT in Patients with R/R LBCL by Age

Clinical trials of axicabtagene ciloleucel (axi-cel) have demonstrated favorable efficacy compared to conventional salvage therapy for the treatment of relapsed or refractory (R/R) large B-cell lymphoma (LBCL). A favorable overall response rate (ORR) was observed with axi-cel treatment after ≥2 prior lines of therapy (LOTs) among patients ≥65 years compared with younger patients in an analysis by the Center for International Blood and Marrow Transplant Research (CIBMTR). At the 64th American Society of Hematology Annual Meeting and Exposition, effectiveness outcomes following treatment with either axi-cel or chemoimmunotherapy (CIT) in an elderly population in real-world settings were reported.

From 79 centers in the United States, 1146 patients treated with axi-cel for R/R LBCL after ≥2 prior LOTs between October 2017 and August 2020 were identified from a non-interventional post-authorization safety study using the CIBMTR registry. A separate cohort of 469 patients treated with CIT for R/R after ≥2 prior LOTs between 2001 and 2014 was identified from the SCHOLAR-1 data set. Patients with the following criteria were excluded: disease histology other than LBCL, missing or <2 prior LOTs, or prior allogeneic stem-cell transplant. Two analysis sets were created: a response rate analysis set, which consisted of patients with ORR and complete response (CR) data available, and a survival analysis set, which included patients with overall survival (OS) data available. Propensity score (PS) matching was performed to balance distribution of baseline characteristics among axi-cel and CIT groups, resulting in 493 and 659 patients in the response rate analysis and survival analysis sets, respectively. Proportions and 95% Clopper-Pearson confidence intervals (CIs) for ORR and CR and Kaplan-Meier estimates for OS were calculated in the PS-matched sets.

At a median follow-up of 24 months for the axi-cel group and 60 months for the CIT group, ORR was 76% (CR rate, 58%) for patients who received axi-cel versus 28% (CR rate, 16%) for those who received CIT in the PS-matched sets. A 57% difference in ORR (55% difference in CR) favoring axi-cel was observed among patients ≥65 years versus a 46% difference in ORR (39% difference in CR rate) in patients <65 years. Based on multivariate analyses in the PS-matched sets, patients who received axi-cel had significantly higher ORR (odds ratio [OR], 7.73; 95% CI, 5.21-11.45) and CR rates (OR, 6.07; 95% CI, 4.15-8.86) compared with CIT, after adjusting for prespecified key prognostic factors. Increased magnitude of benefit in ORR for axi-cel versus CIT was also observed among patients ≥65 years (OR, 18.11) versus patients <65 years (OR, 7.14), as well as increased magnitude of benefit in CR rate (OR, 15.38 for patients ≥65 years vs 5.16 for patients <65 years). Adjusted OS at 12 months was 65% (95% CI, 61-68) for axi-cel versus 23% (95% CI, 18-27) for CIT. Compared with CIT, axi-cel was associated with longer OS across all ages (hazard ratio [HR], 0.30; 95% CI, 0.24-0.37), as well as in patients ≥65 years (HR, 0.32; 95% CI, 0.22-0.48). A sensitivity analysis based on conventional multivariable logistic and Cox regressions in the unmatched full analysis population showed consistent results.

In conclusion, axi-cel provides clinically meaningful benefits to patients of all ages in real-world settings, notably with a greater relative benefit in response rates of axi-cel over CIT in patients ≥65 years. These findings support broader utilization of axi-cel in the elderly population.

Source

Lunning MA, Wang H, Hu Z, et al. Outcomes of axicabtagene ciloleucel in comparison with chemoimmunotherapy in an elderly population for treatment of relapsed or refractory large B-cell lymphoma after two or more lines of therapy. Presented at: 64th American Society of Hematology Annual Meeting and Exposition, December 10-13, 2022; New Orleans, LA. Oral presentation 765.