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Modified Herpes Virus Plus Nivolumab Induces Tumor Regression in Advanced Melanoma

A global Phase III trial is under way with the U.S. Food and Drug Administration set to decide on accelerated approval July 22

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Stock image of a doctor inspecting a patient's mole for skin cancer,
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© NIAID via Flickr

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