One-Time TIL Therapy Lifileucel Delivers 31% ORR with 3-Year Median Response and 20% 5-Year Survival in Heavily Pretreated Melanoma

Lifileucel is an autologous tumor-infiltrating lymphocyte (TIL) product administered following non-myeloablative lymphodepletion and high-dose interleukin-2 (IL-2). In the Phase 2 C-144-01 trial (n = 153; median of three prior lines of therapy, all patients previously exposed to anti–PD-1 agents), a single infusion resulted in a 31.4% ORR, including 5.9% complete responses and 25.5% partial responses. The median time to best response was 1.5 months, and themedian DOR reached 36.5 months, with 31% of responders remaining tumor-free at the 5-year follow-up. The mOS was 13.9 months, and the 5-year OS rate was 19.7%. Toxicities were consistent with the expected effects of lymphodepletion and IL-2, with no late-emerging safety signals observed.