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ccr-22-3136_supplementary_tables_s1-s11_suppts1-ts11.pdf (417.28 kB)

Supplementary Tables S1-S11 from 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

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posted on 2023-05-15, 08:20 authored by Jason R. Westin, Frederick L. Locke, Michael Dickinson, Armin Ghobadi, Mahmoud Elsawy, Tom van Meerten, David B. Miklos, Matthew L. Ulrickson, Miguel-Angel Perales, Umar Farooq, Luciano Wannesson, Lori Leslie, Marie José Kersten, Caron A. Jacobson, John M. Pagel, Gerald Wulf, Patrick Johnston, Aaron P. Rapoport, Linqiu Du, Saran Vardhanabhuti, Simone Filosto, Jina Shah, Julia T. Snider, Paul Cheng, Christina To, Olalekan O. Oluwole, Anna Sureda

Tabulated data supporting ZUMA-7 elderly analysisSupplementary Table S1. Patient-reported outcomes instrumentsSupplementary Table S2. Axi-cel delivery and administration timeSupplementary Table S3. Summary of efficacy and safety outcomes in patients ≥65 years versus all patients in ZUMA-7Supplementary Table S4. Serious adverse events in at least 3 patients in patients ≥65 yearsSupplementary Table S5. Summary of cytopenias present on or after 90 days from initiation of definitive therapy on protocol in patients ≥65 yearsSupplementary Table S6. Deaths in axi-cel and SOC arms for patients ≥65 years (safety analysis set)Supplementary Table S7. Summary of serum analytes in patients <65 years versus ≥65 years in the axi-cel arm (N = 170)Supplementary Table S8. Most common adverse events, cytokine release syndrome, and neurologic events in patients ≥70 yearsSupplementary Table S9. Deaths in axi-cel and SOC arms for patients ≥70 years Supplementary Table S10. Baseline characteristics for quality-of-life analysis in patients ≥65 yearsSupplementary Table S11. Mixed model with repeated measures estimated difference in change from baseline forprespecified patient-reported outcomes measures (quality-of-life analysis set) in patients ≥65 years

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Kite, a Gilead Company

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ARTICLE ABSTRACT

Older patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) may be considered ineligible for curative-intent therapy including high-dose chemotherapy with autologous stem-cell transplantation (HDT-ASCT). Here, we report outcomes of a preplanned subgroup analysis of patients ≥65 years in ZUMA-7. Patients with LBCL refractory to or relapsed ≤12 months after first-line chemoimmunotherapy were randomized 1:1 to axicabtagene ciloleucel [axi-cel; autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy] or standard of care (SOC; 2–3 cycles of chemoimmunotherapy followed by HDT-ASCT). The primary endpoint was event-free survival (EFS). Secondary endpoints included safety and patient-reported outcomes (PROs). Fifty-one and 58 patients aged ≥65 years were randomized to axi-cel and SOC, respectively. Median EFS was greater with axi-cel versus SOC (21.5 vs. 2.5 months; median follow-up: 24.3 months; HR, 0.276; descriptive P < 0.0001). Objective response rate was higher with axi-cel versus SOC (88% vs. 52%; OR, 8.81; descriptive P < 0.0001; complete response rate: 75% vs. 33%). Grade ≥3 adverse events occurred in 94% of axi-cel and 82% of SOC patients. No grade 5 cytokine release syndrome or neurologic events occurred. In the quality-of-life analysis, the mean change in PRO scores from baseline at days 100 and 150 favored axi-cel for EORTC QLQ-C30 Global Health, Physical Functioning, and EQ-5D-5L visual analog scale (descriptive P < 0.05). CAR T-cell expansion and baseline serum inflammatory profile were comparable in patients ≥65 and <65 years. Axi-cel is an effective second-line curative-intent therapy with a manageable safety profile and improved PROs for patients ≥65 years with R/R LBCL.

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