A planned subgroup analysis of the ZUMA-7 trial in patients aged 65 years and older with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) suggests that patients experienced favorable outcomes with axicabtagene ciloleucel (axi-cel) compared with standard-of-care (SOC) therapy.
The results were presented at the EHA 2022 Hybrid Congress by Anna Sureda, MD, PhD, of the Institut Català d’Oncologia–Hospitalet, Universitat de Barcelona in Spain.
This phase 3 trial (ClinicalTrials.gov Identifier: NCT03391466) enrolled patients with LBCL that had relapsed or become refractory within 1 year of receiving first-line chemoimmunotherapy.
Patients were randomly assigned 1:1 to either axi-cel or SOC, which was platinum-based chemoimmunotherapy. Patients in the SOC arm with a partial or complete response could then undergo high-dose therapy and autologous stem cell transplant (HDT-ASCT). The primary endpoint was event-free survival (EFS) by blinded central review, and numerous secondary endpoints were evaluated.
The subgroup analysis included 51 patients in the axi-cel arm and 58 patients in the SOC arm. Median ages were 70 and 69 years in the 2 arms, respectively. High-risk features were represented in more patients in the axi-cel arm at baseline. Most patients (96%) in the axi-cel arm received axi-cel, and 34% of patients in the SOC arm received HDT-ASCT.
With a median follow-up of 24.3 months, the axi-cel arm demonstrated superior EFS compared with SOC (stratified hazard ratio [HR], 0.276; 95% CI, 0.164-0.465; P <.0001). The estimated 2-year EFS rates were 47.8% in the axi-cel arm and 15.1% in the SOC arm.
Axi-cel was associated with a higher objective response rate (88%) than SOC arm (52%; descriptive P <.0001). Complete response rates were 75% in the axi-cel arm and 33% in the SOC arm.
Clinically meaningful differences at day 100 in patient-reported outcomes also favored axi-cel for EORTC QLQ-30 Global Health and Physical Functioning scores and with the EQ-5D-5L visual analogue scale.
In a safety analysis with 49 patients in the axi-cel arm and 55 in the SOC arm, grade 3 or higher adverse events were reported in 94% of patients in the axi-cel arm and in 82% of patients in the SOC arm. Grade 5 adverse events occurred in 1 patient in each arm.
Cytokine release syndrome (CRS) was reported in 98% of patients in the axi-cel arm, with 8% experiencing grade 3 or higher CRS. Neurologic events occurred in 65% of patients in the axi-cel arm (grade 3 or higher in 27%) and in 25% of patients in the SOC arm (grade 3 or higher in 2%).
The investigators concluded that axi-cel demonstrated superior EFS in the second line for this population of patients, in addition to being favored for quality of life and showing a manageable safety profile. Dr Sureda said these outcomes with axi-cel “should help inform treatment choices in second-line relapsed/refractory large B-cell lymphoma” for patients aged 65 years and older.
Disclosures: This research was supported by Kite/Gilead. The presenter declared affiliations with Kite/Gilead, Takeda, Bristol Myers Squibb/Celgene, MSD, Janssen, Amgen, Novartis, Sanofi, Roche, and Alexion.
Sureda A, Westin JR, Locke FL, et al. Clinical and patient-reported outcomes in a phase 3 study of axicabtagene ciloleucel versus standard of care in elderly patients with relapsed/refractory large B-cell lymphoma (ZUMA-7). Presented at EHA 2022; June 9-12, 2022. Abstract S211.