OBJECTIVES :

R/R DLBCL treatment is associated with low response rates and decreased functional status and well-being. Liso-cel is an investigational, CD19-directed CAR T cell product administered at precise doses of CD4+ and CD8+ CAR T cells. In the dose escalation/expansion part of the ongoing TRANSCEND NHL 001 trial (NCT02631044), best overall response rate with liso-cel in the R/R DLBCL cohort was 75% (55% complete responses), with low rates of severe cytokine release syndrome (1%) and neurological events (13%). The objective of this analysis was to estimate preference-weighted health status in patients with R/R DLBCL receiving liso-cel during the trial.

METHODS

Eligible patients with R/R DLBCL (≥18 years, ≥2 prior therapy lines) received lymphodepletion followed by a single liso-cel dose infusion. The EQ-5D-5L (health utility index score and visual analog scale [VAS], which measure patients’ well-being and perceived health status, respectively) was completed and analyzed at baseline, day 29 (month 1), and months 2, 3, and 6. EQ-5D-5L index score was calculated using widely employed US preference weights

RESULTS

At data cutoff, 90/127 patients (mean [SD] age, 61.7 [11.2] years) were evaluable (baseline+≥1 post-baseline assessment). Mean (SD) preference-weighted health status score was 0.83 (0.104) at baseline, which decreased at month 1 (−0.016 [0.144]) followed by increases from baseline at months 2 (0.010 [0.149]) through 6 (0.019 [0.133]); at month 6, 30% of patients experienced clinically meaningful improvements (ie, ≥0.07 based on previous research). Mean global health rating scores (ie, VAS) increased monotonically from 70.2 at baseline to 83.4 at month 6.

CONCLUSIONS

Following liso-cel infusion in patients with R/R DLBCL, mean preference-weighted health status decreased 1-month postinfusion, but increased during months 2–6, with clinically meaningful improvements exceeding the >0.07 established threshold in 30% of patients 6 months postinfusion. Patients’ global health rating scores increased from baseline to month 6 postinfusion.