600 Retreatment with RP1 in combination with nivolumab in patients with advanced anti-PD-1-failed melanoma

作者：Gino K. In, Michael K. Wong, Joseph J. Sacco, Eva Muñoz‐Couselo, Dirk Schadendorf, Georgia M. Beasley, Jiaxin Niu, Bartosz Chmielowski, Trisha M. Wise‐Draper, Mohammed Milhem, Tawnya L. Bowles, Katy K. Tsai, Cleste Lebb, Caroline Gaudy‐Marqueste, Adel Samson, Junhong Zhu, Chris Tucci, Marcus Vinícius Canário Viana, Jeannie W Hou, Caroline Robert · 发表于：Regular and Young Investigator Award Abstracts · 年份：2025 · DOI：10.1136/jitc-2025-sitc2025.0600 · 研究领域：Cancer Immunotherapy and Biomarkers、Melanoma and MAPK Pathways、Cutaneous Melanoma Detection and Management

Background Treatment options for melanoma that has progressed on anti-PD-1 therapy are limited. Vusolimogene oderparepvec (RP1) is a fusion-enhanced HSV-1-based oncolytic immunotherapy. The IGNYTE trial showed that RP1 in combination with nivolumab (nivo) demonstrated clinically meaningful, durable responses (objective response rate, 32.9%; median duration of response, 33.7 months by RECIST 1.1) in patients with anti-PD-1-failed melanoma, with mainly grade 1/2 constitutional-type side effects. The trial allowed retreatment with RP1 for patients deriving clinical benefit. Here, we present the investigator assessment of patients who were retreated with RP1 in the IGNYTE trial.Methods Patients with melanoma and confirmed progression on anti-PD-1 ± anti-CTLA-4 therapy for ≥8 weeks as the last prior treatment were enrolled. During the initial course, RP1 was given intratumorally at 1×10 6 PFU/mL initially, then at 1×107 PFU/mL Q2W (≤7 doses) with intravenous nivo (240 mg). Nivo was then given alone (240 mg Q2W or 480 mg Q4W) for 2 years. Retreatment with RP1 could occur if patients had injectable lesions, stable performance status, and no treatment-related grade 4 adverse events (AEs) or grade 3 injection-site reactions, infections, or immune-mediated AEs lasting >14 days. Additional doses of RP1 were administered at 1x107 PFU/mL Q2W either in combination with nivo or as monotherapy if nivo was stopped due to nivo-related toxicity. An investigator survey was performed to assess ef...