A 3-year landmark overall survival analysis of RP1 plus nivolumab in patients with anti–PD-1–failed melanoma from the IGNYTE clinical trial.

作者：Michael K.K. Wong, Joseph J. Sacco, Gino K. In, Eva Muñoz‐Couselo, Dirk Schadendorf, Jiaxin Niu, Georgia Beasley, Trisha M. Wise‐Draper, Bartosz Chmielowski, Judith Michels, Mohammed Milhem, Tawnya L. Bowles, Katy K. Tsai, Celeste Lebbe, Caroline Gaudy‐Marqueste, Adel Samson, George Kong, Praveen Bommareddy, Jeannie W Hou, Caroline Robert · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco.2026.44.16_suppl.9518 · 研究领域：Virus-based gene therapy research、Immunotherapy and Immune Responses、Cancer Immunotherapy and Biomarkers

9518 Background: Advanced melanoma has a high mortality rate; however, survival for patients (pts) treated with anti–PD-1–based therapy tends to plateau at 3–4 years, suggesting that pts alive at 3 years are likely to have prolonged benefit. This highlights the need for novel therapies that offer increased survival beyond 3-4 years. RP1 (vusolimogene oderparepvec) is an HSV-1–based oncolytic immunotherapy expressing GM-CSF and a fusogenic glycoprotein (GALV-GP-R − ). In the IGNYTE trial (data cutoff [DCO]: 15OCT2024), pts with advanced melanoma that had confirmed progression on anti–PD-1 therapy who received RP1 + nivolumab (nivo) had an objective response rate by RECIST 1.1 of 33.6% (16.4% complete response); median duration of response was 24.8 months. Here, we present a 3-year survival analysis of pts treated with RP1 + nivo from IGNYTE (last pt in: 9MAR2023; DCO: 11JUN2025). Methods: Pts ≥18 years with advanced melanoma and confirmed progression while being treated for ≥8 weeks with anti–PD-1 ± anti–CTLA-4 as the last prior therapy were enrolled (NCT03767348). An initial dose of RP1 was administered intratumorally (1 × 10 6 PFU/mL), followed by up to 7 doses every 2 weeks (Q2W; 1 × 10 7 PFU/mL) in combination with intravenous nivo 240 mg Q2W/480 mg Q4W for up to 2 years; additional RP1 was allowed if protocol-specified criteria were met. This updated analysis evaluated overall survival (OS) using the Kaplan-Meier (KM) method. Results: Of 140 enrolled pts, 49.3% had stage ...