OBJECTIVES

This analysis evaluated health-related quality of life (HRQoL) as assessed by the EQ-5D among patients with R/R MCL following KTE-X19 therapy in the ZUMA-2 single-arm, open-label, phase 2, registrational trial.

METHODS

The EQ-5D (5-level version) was assessed before KTE-X19 administration at baseline, week 4, month 3, and month 6. Mixed models controlling for repeated measures were used to estimate change from baseline with variables for baseline response and time within models. Clinically meaningful thresholds for improvement/decline in overall health were 7 points for the EQ-5D visual analog scale score (VAS).

RESULTS

Of 68 patients treated with KTE-X19, at baseline n=65 completed the VAS and n=62 completed all EQ-5D items. Across all 5 dimensions of the EQ-5D, 66%-95% of patients reported no health problems at baseline. Although 43%-67% reported no health problems at week 4, increases of ≥16 percentage-points were observed by month 3 for mobility, self-care, and usual activities. Mean (SD) baseline VAS was 82.0 (15.4). Estimated mean VAS change from baseline was ­-8.9 (95% CI:-13.7,-4.1) at week 4, -2.1 (-6.5,2.3) at month 3, and 1.4 (-3.8,6.6) at month 6. Relative to baseline, 46% of patients reported stable or improved VAS at week 4, 66% at month 3, and 85% at month 6. Mean (SD) EQ-5D index scores (UK crosswalk) were 0.884 (0.134) at baseline, 0.769 (0.275) at week 4, 0.812 (0.243) at month 3, and 0.853 (0.185) at month 6.

CONCLUSIONS

EQ-5D scores in ZUMA-2 initially declined from baseline to week 4. By month 3, better scores in mobility, self-care, usual activities, and overall health (VAS) were observed, with overall health returning to baseline or better in most patients. Patient-reported outcomes suggest no AE-associated long-term HRQoL deficits following KTE-X19 therapy, with a trend towards improvement beyond baseline over time.