FDA Grants Priority Review to Lifileucel in Advanced Melanoma

Source: OncLive, May 2023

The FDA has granted priority review to the biologics license application (BLA) for the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-144) for the treatment of patients with advanced melanoma who progressed on or after prior anti–PD-1/PD-L1 therapy and targeted therapy.

The BLA was supported by data from cohort 2 (n = 66) and cohort 4 (n = 87) of the phase 2 C-144-01 trial (NCT02360579). Patients from both cohorts, who had all progressed on or after immune checkpoint inhibitor therapy or targeted BRAF/MEK inhibitor therapy where appropriate, experienced an overall response rate (ORR) of 31.4% (95% CI, 24.1%-39.4%). Nine patients achieved a complete response (CR), and 39 patients had a partial response (PR).

The median time from lifileucel infusion to best response was 1.5 months. Notably, 7 patients improved from a PR to a CR as late as 2-plus years following treatment.