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Improved QoL with axi-cel versus standard-of-care in R/R LBCL

Expert
Dr Mahmoud Elsawy, Dalhousie University, Halifax, USA

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Conference
ASH 2021
Trial
Phase 3, ZUMA-7
ZUMA-7 (NCT03391466) is the first randomised, global, phase 3 study evaluating axicabtagene ciloleucel (axi-cel) versus standard-of-care as second-line treatment for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) [1]. Treatment with axi-cel resulted in a clinically meaningful improvement in quality of life (QoL) compared with standard-of-care at day 100, as measured by multiple validated patient-reported outcome (PRO) measures.

Patients with LBCL who relapse early or are refractory to first-line therapy often experience poor outcomes. In addition, patients receiving second-line standard-of-care treatment frequently report poor health-related QoL [2].

Axi-cel is an autologous anti‑CD19 chimeric antigen receptor (CAR) T-cell therapy, approved for patients with R/R LBCL after ≥2 lines of therapy. In the open-label ZUMA-7 study, axi-cel was compared with standard-of-care in the second line. A long-term follow-up analysis of ZUMA-1, which was presented at ASH 2021, demonstrated a 5-year overall survival (OS) rate of 43% after a median follow-up of 63 months for axi-cel in patients with refractory LBCL [3]. Dr Mahmoud Elsawy (Dalhousie University, Halifax, USA) and others conducted the first comparative analysis of CAR T-cell therapy (as second-line treatment) versus standard-of-care on PROs in this patient population.
Improved QoL

Of the 359 enrolled patients, 296 patients had completed PROs at baseline, as well as and ≥1 follow-up measure(s), and were included for analysis. Overall, 70% of the patients had primary refractory disease, 42% had high second-line age-adjusted International Prognostic Index (2–3), and 30% were ≥65 years old.  Patients treated with axi-cel showed a statistically significant increase in QoL compared with patients receiving standard-of-care (P<0.0001) and a clinically meaningful difference at day 100 in mean change of scores from baseline on all prespecified PRO domains (see Figure).

Figure: Change from baseline for prespecified PRO endpoints



These results were confirmed in sensitivity analyses, wherein significance was retained at day 100. Furthermore, also other QoL measures favoured axi-cel over standard-of-care, as indicated by the EORTC QLQ-C30 Global Health Status/QoL (P=0.0124) and EQ-5D-5L VAS (P=0.0004).

According to Dr Elsawy, another important finding was that the mean estimated scores for the axi-cel arm had numerically returned to or exceeded the baseline scores at day 150 compared with the scores of the standard-of-care arm. “This suggests that patients receiving axi-cel return faster to their baseline QoL level compared to those receiving standard-of-care.”
Attrition and additional exploratory analyses

Attrition, for example due to disease progression, new lymphoma therapy, or death, was substantial after Month 9. Attrition was disproportionally higher in the standard-of-care arm and this may have caused biases in patient population. Therefore, score comparisons at later timepoints warrant cautious interpretation.

Additional exploratory analyses of PRO endpoints, such as EORTC QLQ-C30 role functioning, social functioning, fatigue, nausea/vomiting, dyspnoea, insomnia, appetite loss, diarrhoea, and EQ-5D-5L index, clearly showed improvements with axi-cel compared with standard-of-care.
Conclusion

The superior clinical outcomes and patient experiences with axi-cel over standard-of-care may help physicians make informed decisions about the second-line treatment of patients with R/R LBCL.

    1. Elsawy M, et al. Patient-Reported Outcomes in a Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel (Axi-Cel) Versus Standard of Care Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma (ZUMA-7). 430, ASH 2021 Annual Meeting, 11-14 Dec. 

    2. Lin V, et al. J Clin Oncol. 2020;38(15_suppl):e20070.

    3. Jacobson CA, et al. Abstract 1764, ASH 2021 Annual Meeting, 11-14 Dec. 

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