Iovance Biotherapeutics announces five-year results of Amtagvi in melanoma

Iovance Biotherapeutics (IOVA) announced five-year results from the Phase 2 C-144-01 clinical trial evaluating the individualized T cell therapy Amtagvi – lifileucel -. The C-144-01 trial investigated Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 and targeted therapy, where applicable. The five-year results included meaningful overall survival – OS – results and durable responses following one-time treatment with Amtagvi. These results will be presented at the 2025 ASCO Annual Meeting. With a median follow-up of 57.8 months, patients achieved a median OS of 13.9 months, with 19.7% of patients surviving at the five-year mark. The objective response rate was 31.4%, including complete responses in 5.9% of patients and partial response in 25.5%. Among patients who responded to treatments, the median duration of response was 36.5 months. 31.3% of responders completed the five-year assessment with ongoing responses. Adverse events were consistent with known safety profiles of nonmyeloablative lymphodepletion and interleukin-2 administration. The incidence of AEs decreased rapidly within the first two weeks after Amtagvi infusion, and there were no new or late-onset treatment-related AEs.