Overview
- In a Phase I/II IGNYTE trial of 140 patients, the RP1 oncolytic virus combined with nivolumab achieved at least 30% shrinkage in roughly one-third of participants and complete tumor regression in nearly one-sixth
- Uninjected tumors throughout the body responded at similar rates to injected lesions, demonstrating systemic anti-tumor activity
- The combination therapy was well tolerated, with about 90% of patients reporting only mild flu-like side effects such as fatigue and fever
- Results were published in the Journal of Clinical Oncology and presented at the American Society of Clinical Oncology meeting, confirming safety and efficacy in immunotherapy-resistant advanced melanoma
- A global Phase III IGNYTE-3 trial involving over 400 participants has launched to validate these findings while the FDA reviews the RP1-nivolumab regimen