Iovance Biotherapeutics Inc. announced new real-world clinical data for Amtagvi® (lifileucel), a one-time T cell therapy for advanced melanoma. The data, presented at the 2026 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT®) and the Center for International Blood and Marrow Transplant Research (CIBMTR®), demonstrated an objective response rate $(ORR)$ of 44% in a real-world cohort of 41 previously treated advanced melanoma patients. Patients who received Amtagvi earlier in their treatment course showed higher response rates, with a 52% ORR reported after two or fewer prior lines of therapy, compared to 33% after three or more lines. These real-world findings build on the previously reported 31% ORR from the C-144-01 clinical trial, which supported Amtagvi’s accelerated approval by the U.S. FDA in February 2024. Iovance is also conducting the Phase 3 TILVANCE-301 trial to further evaluate Amtagvi in frontline advanced melanoma.

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