A randomized, controlled, multicenter, phase 3 study of vusolimogene oderparepvec combined with nivolumab vs treatment of physician’s choice in patients with advanced melanoma that has progressed on anti–PD-1 and anti–CTLA-4 therapy (IGNYTE-3).

作者：Jason J. Luke, Ardalan Davarifar, Yana G. Najjar, Omid Hamid, Dirk Schadendorf, Michael K.K. Wong, Nikhil I. Khushalani, Paolo A. Ascierto, Tawnya L. Bowles, Mark Navarro, Giuseppe Gullo, Caroline Robert · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.tps9599 · 被引用次数：2 · 研究领域：Cancer Immunotherapy and Biomarkers、Immunotherapy and Immune Responses、vaccines and immunoinformatics approaches

TPS9599 Background: Melanoma is the fifth most common cancer, with ~100,000 new cases and ~8000 related deaths estimated in the US for 2024. First-line systemic treatment with immune checkpoint inhibitors improves the objective response rate (ORR) and extends progression-free survival (PFS) and overall survival (OS) for patients with advanced disease. Among available treatments, combination anti–PD-1 (nivolumab) + anti–CTLA-4 (ipilimumab) therapy is associated with the highest ORR and best PFS and OS. However, only ~50% of patients respond to treatment, and limited options exist for patients whose melanoma progresses following anti–PD-1–based therapy. Vusolimogene oderparepvec (VO; also known as RP1) is a selectively replication-competent herpes simplex virus type 1–based oncolytic immunotherapy that expresses human granulocyte-macrophage colony-stimulating factor and a fusogenic glycoprotein (GALV-GP-R–). Data from a registration-intended cohort of the IGNYTE study (NCT03767348) showed that intratumoral VO + intravenous nivolumab was well tolerated and demonstrated durable, clinically meaningful antitumor activity (ORR, 32.9% per independent central review using Response Evaluation Criteria in Solid Tumors 1.1) in patients with advanced melanoma and confirmed progression on prior anti–PD-1 therapy. IGNYTE-3 will evaluate the OS and clinical benefit of VO + nivolumab for patients with advanced cutaneous melanoma whose disease has progressed after anti–PD-1 and anti–CTLA-4 the...