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Theresa Medina, MD, discusses the long-term efficacy and safety of lifileucel TIL therapy in advanced melanoma.
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"Lifileucel TIL therapy [is an FDA-approved option] for patients who either do not respond to immune checkpoint inhibitor therapy or develop resistance to it."
Theresa Medina, MD, a medical oncologist specializing in melanoma at the University of Colorado Cancer Center–Anschutz Medical Campus, discussed the long-term efficacy and safety of lifileucel (Amtagvi) tumor-infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma, based on 5-year follow-up data from the phase 2 C-144-01 trial (NCT02360579).
The C-144-01 study evaluated a single administration of lifileucel in heavily pretreated patients with unresectable or metastatic melanoma who had progressed on prior immune checkpoint inhibitors. The objective response rate was 31.4%. Of those who responded, 31.3% had ongoing responses at 5 years. Notably, 16 patients converted from stable disease or partial responses to complete responses more than 1 year following treatment, underscoring the durability and delayed immunologic activity of TIL therapy.
The estimated 5-year overall survival rate was 19.7%, with some patients remaining progression free without additional systemic treatment. These data support the hypothesis that lifileucel can elicit durable responses and long-term survival benefits with a one-time infusion, even in the context of checkpoint inhibitor resistance.
According to Medina, lifileucel is a meaningful treatment option for patients with advanced melanoma who have limited alternatives following immunotherapy. She emphasized that the persistence of response without ongoing treatment distinguishes TIL therapy from other cellular or systemic approaches.
In February 2024, the FDA approved lifileucel as the first TIL therapy for the treatment of patients with advanced melanoma that has progressed after anti–PD-1 therapy, marking a critical step forward in adoptive cell therapy. Medina noted that the long-term results from the pivotal C-144-01 trial strengthen the rationale for broader incorporation of TIL therapy into second-line treatment algorithms. Ultimately, Medina stated that lifileucel uses a non-continuous, cell-based therapeutic modality capable of generating long-lasting responses in a subset of patients with refractory disease.
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