Replimune Rises on Melanoma Data, Oncolytic Virus Launch Set for Next Year

Shares of Replimune saw a significant surge of 28% on Thursday following the announcement of promising results for its oncolytic virus therapy, RP1. This therapy, when combined with Opdivo (nivolumab), demonstrated a notable one-third overall response rate (ORR) in melanoma patients who had not responded to previous anti-PD-1 treatments. Encouraged by these results, Replimune is preparing to submit a regulatory application to the FDA in the latter half of the year. Additionally, the company plans to commence patient enrollment for the confirmatory IGNYTE-3 study in the third quarter. 

CEO Sushil Patel expressed confidence in the therapy’s market potential, stating that Replimune aims to commercially launch RP1 next year. The topline results from the Phase I/II IGNYTE-3 study, which involved 140 evaluable patients, showed that the combination of RP1 and Bristol Myers Squibb’s PD-1 inhibitor resulted in a median duration of response surpassing 35 months. Impressively, all patient responses lasted more than 6 months. 

The primary analysis of the study was conducted by an independent central review, which commenced after all patients had been monitored for a minimum of 12 months. RP1 is derived from a genetically modified herpes simplex virus, enhanced with fusogenic protein GALV-GP R- and GM-CSF to increase its potency. These modifications improve the virus’s immunogenicity and stimulate a systemic anti-tumor immune response. 

Replimune intends to present detailed primary analysis data, including key secondary endpoints and subgroup analyses, at an upcoming medical congress. This presentation will offer further insights into the therapy’s efficacy and potential applications, providing the medical community with comprehensive data to evaluate RP1’s viability as a treatment option. 

The promising results for RP1 mark a significant milestone for Replimune, highlighting the potential of oncolytic virus therapies in the treatment of melanoma. As the company advances its regulatory and clinical efforts, it moves closer to providing a new therapeutic option for patients with limited alternatives.