Medina on Patient Selection for Lifileucel in Melanoma

Theresa Medina, MD, associate professor of medicine-medical oncology at the University of Colorado Cancer Center, Anschutz Medical Campus, discusses the clinical potential of lifileucel (Amtagvi), a tumor-infiltrating lymphocyte (TIL) therapy, for patients with advanced melanoma during the 2025 American Society of Clinical Oncology Annual Meeting.¹ Her comments focused on insights from the In the phase 2, registrational, open-label, multicenter, multicohort, C-144-01 study (NCT02360579) and the ongoing search for predictive markers of treatment response.

While the study’s 5-year results demonstrated promising long-term outcomes with a 31.4% response rate and nearly 20% 5-year overall survival, Medina emphasized that more work is needed to identify which patients are most likely to benefit.

Based on accumulated data from the C-144-01 study, including previous publications and the latest ASCO presentation, Medina noted a trend suggesting that earlier treatment with lifileucel may yield better outcomes.

“This is something that we should encourage all patients to be considered for after they have received a first-line PD-1–containing regimen,” she explains in an interview with Targeted Oncology. “If they don’t derive benefit or become resistant, then lifileucel should be considered at that point.”

As lifileucel moves toward broader clinical use following its regulatory approval, understanding how to optimize timing and patient selection will be critical. Medina's comments reinforce the therapy’s potential as a second-line option and underscore the need for future research to refine its use in personalized treatment strategies for metastatic melanoma.

In February 2024, lifileucel was granted accelerated approval by the FDA for the treatment of unresectable or metastatic melanoma who had previously received a PD-1 antibody, including those with BRAF V600-positive disease who had received a BRAF inhibitor with or without a MEK inhibitor.² This marked the first approval of a cellular therapy for the treatment of patients with unresectable or metastatic melanoma. The regulatory decision was supported by data from the C-144-01 study.

REFERENCES:

1. Medina T, Chesney JA, Kluger HM, et al. Long-term efficacy and safety of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: a 5-year analysis of the C-144-01 study. J Clin Oncol. 2025;43(suppl 16):9515. doi: 10.1200/JCO.2025.43.16_suppl.9515

2. FDA approves first cellular therapy to treat patients with unresectable or metastatic melanoma. FDA. February 16, 2024. Accessed July 10, 2025. https://tinyurl.com/yrk3yehh