Overview

• Published July 8 in the Journal of Clinical Oncology and presented at ASCO, RP1 combined with nivolumab induced at least 30% tumor shrinkage in one-third of 140 patients and complete regressions in nearly one-sixth.
• RP1, a modified HSV-1 virus, selectively replicates in injected melanoma cells and triggers immune responses that also shrink uninjected lesions.
• Patients tolerated the combination well, reporting mostly mild adverse events over up to eight cycles of RP1 and nivolumab.
• Replimune and Keck Medicine of USC have initiated the IGNYTE-3 global Phase 3 trial enrolling over 400 patients with immunotherapy-resistant advanced melanoma.
• After granting priority review in January, the FDA is scheduled to decide on accelerated approval for RP1 plus nivolumab by July 22, 2025.