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

Iovance Biotherapeutics, a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, announced five-year results from the Phase 2 C-144-01 clinical trial evaluating the individualized T cell therapy Amtagvi.

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.

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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.”

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Additional details will be presented at ASCO:

  • Rapid Oral Presentation: Lifileucel in patients with advanced melanoma: 5-year outcomes of the C-144-01 study
    • Session: Melanoma/Skin Cancers, Monday, June 2, 2025, 9:45 am – 11:15 am CDT
  • Trial-in-Progress Poster: Phase 2, multicenter study of the lifileucel regimen and pembrolizumab after frontline platinum-doublet chemotherapy and pembrolizumab in advanced non-small cell lung cancer
    • Session: Lung Cancer—Non-Small Cell Metastatic, Saturday, May 31, 2025, 1:30 pm – 4:30 pm CDT

Iovance will host a panel discussion on the evening of Saturday, May 31, 2025 at 6:15 pm CDT (7:15 pm EDT) featuring key opinion leaders in melanoma. Please register here to listen to the live audio webcast or replay: https://edge.media-server.com/mmc/p/jerg4puz.

In February 2024, the U.S. Food and Drug Administration granted accelerated approval to Amtagvi 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. The approval is based on overall response rate and duration of response from the C-144-01 clinical trial. With this approval, Amtagvi became the first one-time T cell therapy for a solid tumor cancer as well as the first treatment option for patients with advanced melanoma after anti-PD-1 and targeted therapy. Iovance is also conducting TILVANCE-301, a Phase 3 trial in frontline advanced melanoma to confirm clinical benefit.

About the C-144-01 Clinical Trial

C-144-01 is a global, multicenter Phase 2 study in which patients received treatment with lifileucel. The study enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR) and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The pivotal Cohort 4 and supportive Cohort 2 of Study C-144-01 enrolled patients that met the same primary eligibility criteria, had the same assessments, and had received the same regimen and lifileucel that was produced using the same manufacturing process, and product formulation. 

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Source – GlobeNewswire