Iovance Biotherapeutics announces publication of five-year analysis of Amtagvi

Iovance Biotherapeutics (IOVA) announced that the Journal of Clinical Oncology has published the final analysis from the Phase 2 C-144-01 clinical trial evaluating the individualized T cell therapy Amtagvi in patients with advanced melanoma. These five-year follow-up results are being simultaneously presented during an oral session at the 2025 American Society of Clinical Oncology Annual Meeting. This 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 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%. Survival outcomes were consistent among responders, regardless of time of onset of response to Amtagvi therapy. The observed safety profile was consistent with that 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.