Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) presented five-year data from its Phase 2 C-144-01 trial of Amtagvi (lifileucel) during the 2025 ASCO Annual Meeting.
A medical staff in white coats monitoring the progress of cancer immunotherapy trials.
A five-year overall survival rate of 19.7% and a median overall survival of 13.9 months were reported in 153 patients with advanced melanoma who had previously received anti-PD-1 and targeted treatments. The intended response rate was 31.4%, with a median response duration of 36.5 months, and 5.9% complete and 25.5% partial responses. At five years, 31.3% of respondents remained active. There were no novel late-onset adverse events, and safety results were in line with established profiles of IL-2 and lymphodepletion. Amtagvi is still the only one-time T cell treatment for solid tumors that has received FDA approval.
In February 2024, Amtagvi was given accelerated FDA approval for melanoma that was metastatic or unresectable following PD-1 and targeted treatments. Patients who had not responded to at least one systemic treatment were selected for the vital C-144-01 trial. Cohorts 2 and 4 of the trial followed the identical manufacturing method and regimen.
Iovance Biotherapeutics, Inc.’s TIL platform, which targets a market where 90% of cancers are solid tumors, is the first to be approved for solid tumors. Tumor tissue is surgically removed, billions of T cells are produced in 34 days, and then the cells are infused following lymphodepletion and IL-2.
Moreover, Iovance Biotherapeutics, Inc. is assessing lifileucel in NSCLC and conducting the TILVANCE-301 Phase 3 trial in frontline melanoma.
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