Iovance Biotherapeutics(IOVA) Globenewswire·2025-06-02 13:29Core Viewpoint - Iovance Biotherapeutics, Inc. announced the five-year follow-up results of the Phase 2 C-144-01 clinical trial for Amtagvi® (lifileucel), showing significant long-term benefits in patients with advanced melanoma, including durable responses and meaningful overall survival rates [2][4][6]. Group 1: Clinical Trial Results - The five-year analysis of the C-144-01 trial included 153 patients and demonstrated unprecedented durability in advanced melanoma patients previously treated with anti-PD-1 and targeted therapies [3][4]. - The objective response rate was 31.4%, with a median time to response of 1.4 months and a median duration of response of 36.5 months [4]. - Nearly one third of responders (31.3%) maintained ongoing responses at the five-year assessment, with a median overall survival (mOS) of 13.9 months and a five-year survival rate of 19.7% [4]. Group 2: Safety Profile - The safety profile of Amtagvi was consistent with nonmyeloablative lymphodepletion and interleukin-2 administration, with no new or late-onset adverse events reported at a median follow-up of 57.8 months [5][6]. - The incidence of adverse events decreased rapidly within the first two weeks after Amtagvi infusion [5]. Group 3: Regulatory Approval and Future Trials - In February 2024, the FDA granted accelerated approval to Amtagvi for treating adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody [6]. - Iovance is conducting the TILVANCE-301 Phase 3 trial in frontline advanced melanoma to confirm the clinical benefit of Amtagvi [6][7]. Group 4: Company Overview - Iovance Biotherapeutics aims to be a leader in developing tumor infiltrating lymphocyte therapies, with Amtagvi being the first FDA-approved T cell therapy for a solid tumor indication [16]. - The company is committed to continuous innovation in cell therapy, including gene-edited cell therapy, to improve patient outcomes [16].