FDA Approval Sought for Lifileucel in Unresectable or Metastatic Melanoma
Source: OncLive, March 2023
Iovance Biotherapeutics has submitted a rolling biologics license application (BLA) to the FDA seeking the approval of the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-44) for the treatment of patients with advanced unresectable or metastatic melanoma who progressed on or after prior anti–PD-1/L1 therapy and targeted therapy.
The BLA is supported by data from 153 patients with advanced melanoma enrolled in cohort 2 (n = 66) and cohort 4 (n = 87) of the phase 2 C-144-01 trial (NCT02360579).
At a median follow-up of 36.5 months, findings showed that these patients experienced an overall response rate (ORR) of 31.4% (95% CI, 24.1%-39.4%) per independent review committee assessment by RECIST v1.1 criteria. Nine patients achieved a complete response (CR) and 39 had a partial response (PR). The median time from lifileucel infusion to best response was 1.5 months, and 7 patients who initially had a PR improved to a CR in the approximate 10 months following the initial analysis of the data.