Overview
- Analyses presented at ASH 2025 pooled 273 patients from CARTITUDE-1 and CARTITUDE-4, associating earlier-line ciltacabtagene autoleucel with stronger progression-free and overall survival.
- Median PFS was 34.9 months in heavily pretreated CARTITUDE-1 patients, while median PFS was not reached in CARTITUDE-4 at 34.0 months of follow-up.
- Patients treated after one or two prior lines had higher baseline CD4-positive naive T-cell percentages at apheresis, a marker that correlated with longer PFS, with immune deterioration appearing to plateau after multiple lines.
- Postinfusion correlative readouts linked durable responses to day-28 activation of M1 tumor-associated macrophages, broader T-cell activation, greater TCR repertoire diversity, and expansion of endogenous CD4 memory clonotypes.
- Investigators recommended earlier-line use based on these mechanistic correlates, building on prior reports of higher MRD negativity and a 45% lower risk of death versus standard care and the FDA’s April 2024 label expansion for lenalidomide-refractory disease after at least one prior line.