Replimune Announces First Patient Dosed in IGNYTE-3 Clinical Trial in Advanced Melanoma

Replimune Group, Inc., a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, announced that the first patient has been randomized and dosed in the IGNYTE-3 study – a global Phase 3 clinical trial assessing the efficacy and safety of RP1 (vusolimogene oderparepvec) plus nivolumab in patients with advanced melanoma who have progressed on anti-PD1 and anti-CTLA-4 drugs or are ineligible for anti-CTLA-4 treatment.

“The start of the IGNYTE-3 trial and randomization of the first patient is an important milestone in advance of our planned BLA submission of RP1 in advanced melanoma later this year,” said Kostas Xynos, MD, PhD, MBA, Chief Medical Officer at Replimune. “This trial is important because it is intended to both support global regulatory interactions and access, and to serve to confirm the clinical benefit reported from the registration intended Phase 2 IGNYTE cohort in anti-PD1 failed melanoma in June.”

Melanoma is the fifth most common cancer with approximately 100,000 new cases and 8,000 deaths estimated in the U.S. in 2024. Standard of care therapy includes treatment with immune checkpoint blockade, to which approximately half of patients will not respond or will progress following treatment. Treatment options are limited after immune checkpoint blockade therapy, with no standard of care available to patients.

“Clinical trials like IGNYTE-3 are important in the melanoma community and we are excited that another study is open for physicians and patients to consider,” said Kyleigh LiPira, CEO of the Melanoma Research Foundation. “As a patient advocacy organization, our mission is to eradicate melanoma by accelerating medical research while educating to and advocating for the melanoma community. Creating awareness for clinical trials is an important part of that mission.”

The IGNYTE-3 trial (NCT06264180) will enroll 400 patients and evaluate RP1 plus nivolumab versus a defined list of physician’s choice treatment options, in patients with advanced melanoma who progressed on anti-PD1 and anti-CTLA-4 therapy or who are ineligible for anti-CTLA-4 treatment. The primary endpoint of the study is overall survival (OS). Key secondary endpoints are progression free survival (PFS) and objective response rate (ORR).