Replimune soars on melanoma data, aims for oncolytic virus launch next year

06 Jun 2024
firstwordpharma.com
Clinical StudyClinical Result
Shares of Replimune jumped 28% Thursday after the company shared that its oncolytic virus RP1, in combination with Opdivo (nivolumab), achieved a one-third overall response rate (ORR) in patients with melanoma who failed prior anti-PD-1 treatment.
The company now plans to submit an application with the FDA next half for RP1, and begin enrolling the confirmatory IGNYTE-3 study in the third quarter. CEO Sushil Patel added that Replimune expects to commercially launch the therapy next year.
Topline results from the Phase I/II IGNYTE-3 study demonstrate that, in 140 evaluable patients, RP1 plus Bristol Myers Squibb’s PD-1 inhibitorPD-1 inhibitor led to a median duration of response exceeding 35 months, with all responses lasting more than 6 months.
Replimune said that the primary analysis by independent central review was triggered once all patients had been followed for at least 12 months.
RP1 is a genetically modified strain of herpes simplex virus engineered with fusogenic protein GALV-GP R- and GM-CSF to boost potency, immunogenicity, and the activation of a systemic anti-tumor immune response.
The company plans to present the primary analysis data, including key secondary endpoint data and subgroups, at an upcoming medical congress.
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