Lifileucel for Unresectable or Metastatic Melanoma
Source: The Asco Post , March 2024
On February 16, 2024, lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, was granted accelerated approval for adults with unresectable or metastatic melanoma previously treated with a PD-1–blocking antibody, and if BRAF V600 mutation–positive, a BRAF inhibitor with or without a MEK inhibitor. Lifileucel is the first treatment for cancer that uses tumor-infiltrating lymphocytes, or TILs.
Supporting Efficacy Data
Approval was based on the LN-144 trial (ClinicalTrials.gov identifier NCT02360579), in which 73 evaluable patients received a single intravenous infusion of lifileucel at a median dose of 21.1 × 109 viable cells after lymphodepletion with cyclophosphamide, mesna, and fludarabine. After the lifileucel dose, patients received interleukin-2 (aldesleukin) doses to support cell expansion in vivo.
An objective response was observed in 23 of 73 patients (31.5%, 95% confidence interval [CI] = 21.1%–43.4%), with a complete response in 3 (4.1%). A median duration of response was not reached (95% CI = 4.1 months to not reached), with 10 responses ongoing at ? 12 months.