Replimune Doses First Patient in IGNYTE-3 Trial for Advanced Melanoma

Replimune Group, Inc., a clinical-stage biotechnology company, has initiated a global Phase 3 trial, IGNYTE-3, to evaluate the efficacy and safety of its oncolytic immunotherapy, RP1 (vusolimogene oderparepvec), in combination with nivolumab in patients with advanced melanoma. This trial targets individuals who have either progressed on anti-PD1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The first patient has already been randomized and dosed, marking a significant milestone ahead of the planned Biologics License Application (BLA) submission for RP1 in advanced melanoma later this year.

Dr. Kostas Xynos, Chief Medical Officer at Replimune, emphasized the importance of this trial for both global regulatory support and to confirm the clinical benefits observed in the Phase 2 IGNYTE cohort for anti-PD1 failed melanoma. The trial is expected to strengthen regulatory interactions and broaden access to the treatment globally.

Melanoma remains a significant health concern, being the fifth most common cancer with an estimated 100,000 new cases and 8,000 deaths in the U.S. in 2024 alone. Current standard treatments involve immune checkpoint blockades, but about half of the patients do not respond or relapse after treatment, leaving limited options for further therapy.

Kyleigh LiPira, CEO of the Melanoma Research Foundation, highlighted the trial’s potential impact on the melanoma community. As a patient advocacy organization, their mission is to eradicate melanoma by promoting medical research, education, and awareness, particularly about clinical trials that open new treatment possibilities.

The IGNYTE-3 trial (NCT06264180) plans to enroll 400 patients, comparing RP1 plus nivolumab against a list of physician-selected treatments for advanced melanoma patients who have progressed on or are ineligible for anti-CTLA-4 therapy. The primary endpoint of the study is overall survival, with key secondary endpoints including progression-free survival and objective response rate.

RP1, Replimune’s lead product candidate, is derived from a proprietary strain of the herpes simplex virus. It is genetically modified to include a fusogenic protein and the GM-CSF gene, which aims to enhance tumor cell destruction, increase immunogenicity of tumor cell death, and stimulate a systemic anti-tumor immune response.

Founded in 2015 and headquartered in Woburn, Massachusetts, Replimune is committed to revolutionizing cancer treatment through its innovative oncolytic immunotherapies. The company’s RPx platform is based on a potent HSV-1 backbone designed to maximize immunogenic cell death and induce a systemic anti-tumor response. This platform is intended to work synergistically with various established and experimental cancer treatments, offering versatility in its development and application.

Replimune’s goal is to transform cancer treatment by leveraging their unique RPx platform, which features dual local and systemic activities. This includes direct virus-mediated tumor killing that releases tumor-derived antigens and modifies the tumor microenvironment to trigger a strong, durable systemic immune response. 

With the advancement of the IGNYTE-3 trial, Replimune continues to push the boundaries of cancer treatment, offering hope for patients with limited options after standard therapies. The trial’s results could pave the way for new, effective therapies in treating advanced melanoma.

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