Lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.) improved overall survival (OS) results and durable responses at five years following one-time treatment, according to a Phase 2 C-144-01 clinical trial of advanced melanoma patients.

The study is slated for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

Lifileucel received accelerated approval from the U.S. Food and Drug Administration in February 2024 for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.

Lifileucel works by collecting and expanding a patient’s unique T cells from their tumor, and then reinfusing them back into the body to fight cancer. These T cells, specifically tumor-infiltrating lymphocytes (TILs), are engineered to recognize and attack tumor cells.

Data From Advanced Melanoma Patients

The new long-term data are from 153 advanced melanoma patients combined from cohorts 2 and 4 of the C-144-01 trial who were previously treated with anti-PD-1 and targeted therapy, where applicable.

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, the study showed.

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,” says Friedrich Graf Finckenstein, MD, Chief Medical Officer of Iovance, in a news release. “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.”