Real-World Data Demonstrate a 49% Response Rate for Commercial Amtagvi® in Patients with Advanced Melanoma

Core Insights - Iovance Biotherapeutics, Inc. announced positive results from a real-world study demonstrating the effectiveness of its TIL therapy, Amtagvi (lifileucel), for patients with advanced melanoma previously treated with immune checkpoint inhibitors [2][3] - The study showed an overall response rate (ORR) of 48.8% among 41 evaluable patients, with a higher ORR of 60.9% in patients who had received two or fewer prior lines of therapy [3][5] - Amtagvi received accelerated approval from the FDA in February 2024, marking it as the first one-time T cell therapy for solid tumors and the first approved treatment for advanced melanoma after anti-PD-1 and targeted therapy [5][12] Company Overview - Iovance Biotherapeutics focuses on developing and delivering innovative TIL therapies for cancer patients, aiming to harness the immune system to target diverse cancer cells [12][14] - The company is conducting a Phase 3 trial, TILVANCE-301, to further confirm the clinical benefits of Amtagvi in frontline advanced melanoma [5][12] Product Information - Amtagvi is indicated for adults with unresectable or metastatic melanoma that has not responded to prior PD-1 blocking therapy and, if applicable, BRAF inhibitors [6][12] - The therapy is derived from the patient's own tumor, which is processed to produce billions of viable T cells for treatment [13]