FDA Approves Lifileucel for Unresectable or Metastatic Melanoma
Source: OncLive, February 2024
Adjuvant checkpoint inhibitor therapy is the standard of care for resectable melanoma. Although many patients derive lasting benefit from the treatment, a substantial number experience disease recurrence.
The FDA has granted accelerated approval to lifileucel (Amtagvi) for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.
The decision is supported by data from the phase 2 C-144-01 trial (NCT02360579), which showed that in those who received the recommended dose (n = 73), the objective response rate (ORR) was 31.5% (95% CI, 21.1%-43.4%); this included a complete response rate of 4.1% and a partial response rate of 27.4%.
Of those who responded, 56.5%, 47.8%, and 43.5% continued to respond without tumor progression or death at 6, 9, and 12 months, respectively. The median duration of response (DOR) had not been reached (NR; 95% CI, 4.1 months-NR). The median time to initial response to the therapy was 1.5 months.