Biosafety analysis from the skin cancer cohorts in the IGNYTE clinical trial of RP1.

作者：Trisha M. Wise‐Draper, Caroline Robert, Michael K.K. Wong, Joseph J. Sacco, Gino K. In, Eva Muñoz‐Couselo, Dirk Schadendorf, Georgia M. Beasley, Jiaxin Niu, Bartosz Chmielowski, Mohammed Milhem, Tawnya L. Bowles, Katy K. Tsai, Célèste Lebbé, Caroline Gaudy‐Marqueste, Junhong Zhu, Jeannie W Hou, Robert S. Coffin, Aaron Clack, Praveen K. Bommareddy · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.9534 · 被引用次数：1 · 研究领域：Cutaneous Melanoma Detection and Management、Melanoma and MAPK Pathways、Cutaneous lymphoproliferative disorders research

9534 Background: RP1 (vusolimogene oderparepvec) is an HSV–based oncolytic immunotherapy administered intratumorally. RP1 + nivolumab (nivo) has demonstrated deep, durable responses with favorable safety in advanced melanoma. We report biodistribution and shedding data from the skin cancer cohorts of the IGNYTE trial (NCT03767348) . Methods: Following RP1 injection into superficial and/or deep lesions, injection sites were covered with occlusive dressings. Injection sites, dressings and mucosa were swabbed, and blood and urine were collected pre-dose, during treatment, and at follow-up visits. Samples were assessed for RP1 DNA by qPCR. Swab samples positive for RP1 DNA were further assessed by TCID50 assay for live RP1. Results: The highest incidence of RP1 DNA was from injection-sites where RP1 was detected in ~35% of samples for up to 15 days post-injection. Blood samples showed the presence of low copy numbers of RP1 DNA (122/1573 [7.8%]) in ~20% (53/274) of pts during or after RP1 treatment. The highest levels were detected in blood within 6 hours of injection and decreased thereafter. RP1 was only very rarely detected and at low copy number in urine samples (3/1976 [0.2%]) from 0.7% (2/273) pts at 15 days post-injection, with all subsequent samples testing negative. RP1 DNA was detected on injection-site dressing exteriors less often (9.5% of 1114 samples) than from injection sites (18.4% of 1947 samples), demonstrating that the dressings act as a barrier to RP1. RP1 DNA...