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Iovance Announces Five-year Results of Amtagvi® (lifileucel) in Patients with Advanced Melanoma at ASCO Annual Meeting

Core Insights - Iovance Biotherapeutics announced five-year results from the Phase 2 C-144-01 clinical trial for Amtagvi, demonstrating a five-year overall survival rate of 20% in patients with advanced melanoma previously treated with immune checkpoint inhibitors [1][2][3] Clinical Trial Results - The C-144-01 trial involved 153 patients with advanced melanoma, showing a median overall survival (OS) of 13.9 months and an objective response rate of 31.4%, with complete responses in 5.9% and partial responses in 25.5% of patients [3][7] - Among responders, the median duration of response was 36.5 months, with 31.3% of responders maintaining ongoing responses at the five-year assessment [3][5] Safety Profile - Adverse events were consistent with known safety profiles of nonmyeloablative lymphodepletion and interleukin-2 administration, with a rapid decrease in incidence within the first two weeks post-infusion and no new or late-onset treatment-related adverse events reported [4][5] Regulatory Approval - The U.S. FDA granted accelerated approval to Amtagvi in February 2024 for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, marking it as the first one-time T cell therapy for solid tumors [7][11] Future Developments - Iovance is conducting the TILVANCE-301 Phase 3 trial to confirm the clinical benefit of Amtagvi in frontline advanced melanoma [7][10]