CARTITUDE-4 updated analysis: Cilta-cel for Len-refractory MM

Updated analyses from phase III CARTITUDE‑4 (NCT04181827), evaluating ciltacabtagene autoleucel (cilta-cel; n = 208) vs standard-of-care (SoC) pomalidomide + bortezomib + dexamethasone (n = 28) or daratumumab + pomalidomide + dexamethasone (n = 183) for the treatment of lenalidomide-refractory multiple myeloma (MM) after 1–3 prior lines of therapy, were published in The Lancet Oncology by Einsele et al.

Key data: At a median follow-up of 33.6 months, median progression-free survival (PFS) was not reached (NR) with cilta-cel (95% confidence interval [CI], 34.5 months–not evaluable [NE]) vs 11.8 months (95% CI, 9.7–14.0) with SoC, corresponding to a 71% reduction in the risk of progression or death (hazard ratio [HR], 0.29; 95% CI, 0.22–0.39). Median overall survival (OS) was NR in either arm but favored cilta-cel (HR, 0.55; 95% CI, 0.39–0.79; p = 0.0009). Complete response or better occurred in 77% of patients with cilta-cel and 24% with SoC. Grade 3/4 treatment-emergent adverse events occurred in 89% and 93%, respectively.

Key learning: Cilta-cel was associated with extended PFS and OS, and deeper responses compared with SoC regimens in lenalidomide-refractory MM after 1–3 prior therapies.