Iovance publishes five-year analysis of Amtagvi in advanced melanoma

Iovance Biotherapeutics announced that the Journal of Clinical Oncology has published the final analysis from a phase 2 trial evaluating the autologous T-cell therapy Amtagvi (lifileucel) in a melanoma patient population resistant to immune checkpoint inhibitor therapy, in which Amtagvi has demonstrated long-term benefit and meaningful overall survival.

The follow-up results were simultaneously presented during an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

The five-year analysis of the C-144-01 trial represents unprecedented durability and duration of follow-up in advanced melanoma patients previously treated with anti-PD-1 and targeted therapy, where applicable. The analysis includes 153 patients from cohorts 2 and 4 of the C-144-01 trial.

One-time Amtagvi treatment demonstrated long-term benefit in heavily pretreated patients, including deep and durable responses, meaningful overall survival without further treatment, and no new or late-onset adverse events at a median follow-up of 57.8 months. The objective response rate was 31.4% with a median time to response of 1.4 months and a median duration of response of 36.5 months. Nearly one third of responders (31.3%) completed the five-year assessment with ongoing responses. The median overall survival was 13.9 months with a five-year survival rate of 19.7%

In February 2024, Amtagvi was granted U.S. FDA accelerated approval for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.