Iovance Announces Five-year Results of Amtagvi (lifileucel) in Patients with Advanced Melanoma at ASCO Annual Meeting

One-time Amtagvi Treatment Demonstrated Durable Responses and a Five-year Overall Survival Rate of 20%

Five-year Follow Up is Unprecedented for Any Therapy in Patients with Advanced Melanoma Previously Treated with Immune Checkpoint Inhibitor

SAN CARLOS, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today 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 American Society of Clinical Oncology (ASCO) Annual Meeting.

The long-term data are from 153 patients combined from cohorts 2 and 4 of the C-144-01 trial. 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. Nearly a third of responders (31.3%) completed the five-year assessment with ongoing responses.

Adverse events (AEs) 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.

“As the first one-time cell therapy approved for a solid tumor cancer, Amtagvi offers a compelling and differentiated treatment option, potentially transforming care within the advanced melanoma community,” said Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance. “These five-year data represent the longest follow-up in a multicenter TIL therapy study, reinforcing the deep and lasting responses, and favorable long-term safety with Amtagvi. In addition, we remain committed to realizing the potential of novel T cell therapies for difficult-to-treat solid tumor cancers representing 90 percent of all diagnosed cancers today.”