FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma
Source: The Asco Post, February 2024
On February 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, for adult patients with unresectable or metastatic melanoma who were previously treated with a PD-1 blocking antibody, or, if they have BRAF V600 mutation–positive disease, a BRAF inhibitor with or without a MEK inhibitor.
C-144-01 Trial
Safety and efficacy were evaluated in the global, multicenter, multicohort, open-label, single-arm C-144-01 trial (ClinicalTrials.gov identifier NCT02360579) in previously treated patients with unresectable or metastatic melanoma who had previously been treated with at least one systemic therapy including a PD-1–blocking antibody, and if BRAF V600 mutation–positive, a BRAF inhibitor with or without a MEK inhibitor. Among 89 patients who received lifileucel, 2 patients were excluded because the product did not meet specification, and 5 patients were excluded due to product comparability.
Lifileucel was administered following a lymphodepleting regimen consisting of cyclophosphamide at 60 mg/kg daily with mesna for 2 days followed by fludarabine at 25 mg/m2 daily for 5 days. Three to 24 hours after infusion, patients received IL-2 (aldesleukin) at 600,000 IU/kg every 8 to 12 hours for up to six doses in order to support cell expansion in vivo. The median administered lifileucel dose was 21.1 × 109 viable cells. The median number of administered IL-2 (aldesleukin) doses was six.