https://orcid.org/0000-0001-6896-1367
Key Points
HRQoL worsened 1 month after axi-cel infusion but recovered by 3 months and remained stable or improved by 12 months.
HRQoL recovery in transplant-ineligible patients from ALYCANTE was similar to or better than in transplant-eligible patients from ZUMA-7.
The phase 2 ALYCANTE trial aimed to evaluate the investigator-assessed complete metabolic response at 3 months from the axi-cel infusion as a primary endpoint in patients with high-risk relapsed/refractory large B-cell lymphoma who are ineligible for autologous stem cell transplantation (ASCT). This study showed a significant improvement in complete metabolic response rate at 3 months based on historical controls. The present study reports the health-related quality of life (HRQoL) results as a secondary endpoint. HRQoL was assessed using the EORTC QLQ-C30 cancer-specific questionnaire, the QLQ-NHL-HG29 high-grade non-Hodgkin lymphoma module, and the EQ-5D-5L generic questionnaire at baseline and 1, 3, 6, and 12 months post-axi-cel infusion. Among the 62 patients included, 60 (97%) completed a baseline and at least one post-baseline HRQoL assessment. At 1 month post-infusion, adjusted mean change in HRQoL scores from baseline showed a clinically significant deterioration (greater than the clinical threshold) in physical, role, social functioning and fatigue. However, all HRQoL dimensions recovered by 3 months post-infusion and remained stable or continued to improve by 12 months. In an exploratory analysis, adjusted mean change in HRQoL score from baseline in ALYCANTE was similar to or better than in ASCT-eligible patients who received axi-cel in the phase 3 ZUMA-7 trial. Finally, the global health status and fatigue scores of the ALYCANTE population improved to levels comparable to the general French population of similar age by 3 months post-infusion. These findings indicate that axi-cel improves HRQoL regardless of transplant eligibility, supporting its use across a broad patient population. NCT04531046
