Iovance Biotherapeutics announced five-year follow-up data from the Phase 2 C-144-01 trial of its tumor-infiltrating lymphocyte (TIL) therapy, Amtagvi (lifileucel), for advanced melanoma patients previously treated with anti-PD-1 and targeted therapy. The study showed a 20% five-year overall survival rate and durable responses after a single Amtagvi treatment. These findings, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, represent the longest follow-up in a multicenter TIL therapy study.
This five-year data is crucial for the field of oncology, particularly for advanced melanoma, where long-term survival remains a significant challenge. The 20% five-year survival rate observed in this trial, after patients had already progressed on standard treatments like anti-PD-1 and targeted therapies, offers a new perspective on the potential for long-term disease control with TIL therapy. This strengthens the clinical value proposition of Amtagvi and offers hope for patients who have exhausted other treatment options.
In the 153-patient study, the median overall survival was 13.9 months. The objective response rate was 31.4%, with 5.9% achieving a complete response and 25.5% a partial response. The median duration of response was 36.5 months, and almost a third of responders maintained their response at the five-year mark. Adverse events were consistent with the established safety profile of non-myeloablative lymphodepletion and interleukin-2 administration, declining rapidly within two weeks of Amtagvi infusion, with no new or late-onset treatment-related adverse events reported.
These long-term results further validate Amtagvi’s potential to become a key player in the advanced melanoma treatment landscape. The data could influence treatment guidelines and encourage broader adoption of TIL therapy, potentially opening doors for Iovance to expand into earlier treatment lines. Furthermore, the positive outcomes may stimulate further research and development in TIL therapies for other solid tumor cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
