MRA Meet Ups: Oncolytic Immunotherapy, Clinical Trials, & the Emerging RP1 Treatment

Jul 2, 2025

On July 1^st, MRA hosted another installment in our MRA Meet-Ups series, where we regularly connect with the melanoma community to discuss important topics, share insights and experiences, and ask questions. The session, called "Oncolytic Immunotherapy, Clinical Trials, & the Emerging RP1 Treatment", featured Dr. Yana Najjar of UPMC Hillman Cancer Center. Moderated by MRA’s Director of Communications and Engagement Dana Deighton, the discussion explored the science behind oncolytic immunotherapies, the critical role of clinical trial participation, and the promise of RP1 - a next-generation therapy being studied in combination with nivolumab for advanced melanoma as part of the ongoing IGNYTE-3 clinical trial (NCT06264180). This exciting combination is currently under priority review by the FDA, following the acceptance of a Biologics License Application (BLA) earlier this year. The BLA submission was supported by primary data from the IGNYTE clinical trial, and a final decision from the FDA is expected in the coming months. If approved, RP1 could be a groundbreaking new option for patients with advanced melanoma.

_{RP1 Status Update:}_{On July 22, trial sponsors announced that they received a complete response letter (CRL) from the FDA regarding its biologics license application (BLA) for RP1. In its letter, the FDA indicated that it was unable to approve the BLA in its current form. MRA is joining forces with peer organizations including AIM at Melanoma Foundation and Melanoma Research Foundation (MRF) to invite patients, families, caregivers and physicians to make their voices heard in responsce to the FDA decision. AIM at Melanoma Foundation will be compiling these stories.}_{Learn more and share your story.}

Topics discussed included:

An overview of oncolytic immunotherapies, how they work, and how they differ from the immunotherapies that are the current standard of care in advanced melanoma,
The science behind the new biologic RP1 and how the modified herpes simplex virus is used,
The process of administering the investigational RP1 treatment to patients,
A deep dive into the ongoing IGNYTE-3 clinical trial, including study goals, eligibility criteria, and more,
Prior data that has led to the acceptance of a Biologics License Application (BLA) earlier this year,
& more!

Watch the full recording:

^{For those looking for a clinical trial option for patients with advanced melanoma that has progressed on certain immunotherapies (anti-PD-1 & anti-CTLA-4), please visit}^{clinicaltrials.gov}^{to learn about the ongoing IGNYTE-3 trial.}