Safety and feasibility of intratumoral injection of RP1 or RP2 oncolytic immunotherapies in visceral metastases.

作者：Caroline Robert, Tawnya L. Bowles, Mark R. Middleton, Judith Michels, Miguel F. Sanmamed, Ari VanderWalde, Jiaxin Niu, Caroline Gaudy‐Marqueste, Eva Muñoz‐Couselo, Gino K. In, M. De Miguel, Andres Cervantes, Georgia Beasley, Tim Liu, Kumiko Yanase, Chris Tucci, Danielle Ulanet, Jeannie W Hou, Gary Vanasse, Mohammed Milhem · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco.2026.44.16_suppl.2597 · 研究领域：Virus-based gene therapy research、Monoclonal and Polyclonal Antibodies Research、Cancer Immunotherapy and Biomarkers

2597 Background: RPx is an investigational HSV-1-based oncolytic immunotherapy platform including RP1 (vusolimogene oderparepvec) and RP2. RP1 expresses GM-CSF and a fusogenic glycoprotein (GALV-GP-R – ); RP2 also expresses an anti–CTLA-4 antibody-like molecule. We report safety data from patients (pts) who received intratumoral (IT) injections of RP1/2 into visceral metastases (mets). Methods: Pts with advanced/metastatic solid tumors were enrolled into RP1/2 clinical trials (RP1: NCT03767348; RP2: NCT04336241). RP1/2 was injected into visceral tumors using CT or ultrasound guidance. The recommended needle gauges ranged from 17-27G. Pts received RP1/RP2 for up to 8 doses as monotherapy or in combination with nivolumab IV starting at cycle 2 or 4 for up to 2 years. Additional RP1/2 doses could be given if protocol-specified criteria were met. This analysis evaluated safety among pts receiving IT RP1/2 injections to visceral mets (defined as lung or liver mets). All safety data presented includes events occurring within 7 days after injection (except where noted). Results: As of data cutoff (RP1: 15OCT2024; RP2: 29AUG2025), there were a total of 665 RP1/2 injections into the lung (n = 125; median lung injections/pt/treatment course [c]: RP1 = 5.5 and RP2 = 8) and liver (n = 540; median liver injections/pt/c): RP1 and RP2 = 5) among 105 pts. The most common treatment-related adverse events (AEs) were pyrexia, chills, and fatigue (Table). A total of 9 pneumothorax (PTX) events o...