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Iovance Biotherapeutics Announces First Patient Randomized in Phase 3 TILVANCE-301 Trial in Frontline Advanced Melanoma
Global Trial of Iovance TIL Therapy Lifileucel in Combination with Pembrolizumab SAN CARLOS, Calif., June 15, 2023 (GLOBE NEWSWIRE) -- Iovance
About this update from Iovance Biotherapeutics, Inc.
[{"type":"text","content":"Global Trial of Iovance TIL Therapy Lifileucel in Combination with Pembrolizumab\nSAN CARLOS, Calif., June 15, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, announced that the first patient was recently randomized in TILVANCE-301, a global, multicenter, registrational Phase 3 trial comparing Iovance TIL therapy lifileucel in combination with pembrolizumab versus pembrolizumab monotherapy in frontline advanced (unresectable or metastatic) melanoma. Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, “Our strategy is to offer TIL therapy across all lines of treatment for patients with advanced melanoma. Randomizing the first patient in TILVANCE-301, our first Phase 3 trial at Iovance, is an important milestone. The trial offers TIL therapy as part of an earlier treatment approach for frontline advanced melanoma, while serving as a confirmatory trial to convert an accelerated approval to full approval for lifileucel in post-anti-PD-1 melanoma. TILVANCE-301 is expected to be well underway at the time of potential accelerated approval in this initial indication. This trial may also provide important insights into the Iovance platform approach for TIL and anti-PD-1 therapy combinations in additional solid tumors.” TILVANCE-301 builds on Iovance clinical data and decades of experience at the National Cancer Institute (NCI) on the use of TIL therapy in early line advanced melanoma patients. An oral session at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2021 highlighted positive results for Iovance TIL therapy in combination with pembrolizumab in patients with advanced melanoma, cervical and head and neck cancers who were naïve to prior anti-PD-1 therapy. In April 2022, Iovance announced updated positive results demonstrating a 67% ORR and durability of response for lifileucel in combination with pembrolizumab in advanced melanoma from Cohort 1A of the IOV-COM-202 trial, which have remained consistent in nearly 20 patients treated to date. The U.S. Food and Drug Administration (FDA) previously agreed that dual primary endpoints of objective response rate (ORR) and progression free survival (PFS) in ...