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Genetically Engineered Herpes Virus Shows New Promise Against Treatment-Resistant Melanoma

Regulators will decide on accelerated approval this month, marking the start of a global Phase 3 study.

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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

  • RP1 is a modified HSV-1 virus engineered to eliminate cold-sore genes and boost immune activation against tumor cells.
  • In a phase 1–2 trial of 140 patients with immunotherapy-resistant melanoma, one-third achieved at least 30% tumor shrinkage.
  • Nearly one in six participants experienced complete regression of injected and uninjected tumors, indicating a systemic response.
  • The combination with nivolumab was well tolerated, with mostly mild side effects and a favorable safety profile.
  • Following FDA priority review granted in January, a 400-patient global Phase 3 trial has been launched to confirm efficacy.