Best-in-class real-world data support early Amtagvi (lifileucel) treatment in advanced melanoma – Iovance Biotherapeutics

Iovance Biotherapeutics Inc. announced data demonstrating a best-in-class profile for commercial Amtagvi (lifileucel) with unprecedented response rates in a real-world clinical, retrospective study in patients with advanced (unresectable or metastatic) melanoma. Amtagvi is the first one-time T cell therapy for a solid tumor cancer as well as the only FDA-approved treatment for advanced melanoma patients previously treated with anti-PD-1 and targeted therapy, where applicable.

The real-world results were highlighted in an oral presentation at the 2026 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) in Salt Lake City, UT.

In total 41 evaluable patients with previously treated advanced melanoma received commercial Amtagvi according to the U.S. prescribing information at four authorized treatment centers. The physician-assessed confirmed objective response rate (ORR) was 44% (18/41) and the disease control rate was 73% (30/41). Response rates were higher with earlier Amtagvi treatment. The ORR was 52% (12/23) following two or fewer lines of therapy compared to an ORR of 33% (6/18) after three or more lines of therapy. The unprecedented real-world response rates also improved upon the 31% ORR in the C-144-01 clinical trial that supported the U.S. FDA accelerated approval of Amtagvi.

Dr. Lilit Karapetyan of H. Lee Moffitt Cancer Center & Research Institute stated, “The real-world response rate builds on existing clinical data and supports consideration of lifileucel as soon as possible after immune checkpoint inhibitor treatment. An overall response rate of 44% was observed in the full cohort, with a 52% response rate among patients treated in earlier lines of therapy. I am encouraged by the potential for an increasing number of patients to benefit as adoption of TIL therapy continues.”

Daniel Kirby, Chief Commercial Officer of Iovance, stated, “The real world Amtagvi data with impressive response rates, paired with unprecedented five-year durability and survival data, demonstrate a best-in-class profile and better outcomes in patients treated earlier.”

The U.S. FDA granted accelerated approval for Amtagvi in February 2024 based on ORR and duration of response (DOR) from the C-144-01 clinical trial. The published final five-year analysis demonstrated unprecedented durability and follow-up in previously treated advanced melanoma patients, with ~31% ORR, median DOR of 36+ months, and a 20% five-year overall survival.

Iovance is currently  conducting TILVANCE-301, a Phase III clinical trial in frontline advanced melanoma, to confirm clinical benefit.

See citation- Medina  T,, Chesney JA , Kluger H  et al.  Long-Term Efficacy and Safety of Lifileucel Tumor-Infiltrating Lymphocyte Cell Therapy in Patients With Advanced Melanoma: A 5-Year Analysis of the C-144-01 Study. J Clin Oncol. 2025  43:3565 JCO-25-00765 DOI:10.1200/JCO-25-00765