TUDRIQEV (vusolimogene oderparepvec-wtpg) and OPDIVO (nivolumab) - (IGNYTE-3)

August 6, 2026: Replimune Group, Inc. (NASDAQ: REPL) said the FDA granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg; previously RP1) plus nivolumab for adults with unresectable advanced cutaneous melanoma that progressed on a PD-1-blocking antibody-based regimen. The approval is based on objective response rate and duration of response and remains contingent on confirmatory clinical benefit.

In the IGNYTE Phase 1/2 registrational melanoma cohort, 140 patients were enrolled; 91 patients with at least one non-injected lesion were efficacy-evaluable. In that population, TUDRIQEV plus nivolumab produced a 24.2% ORR and median duration of response of 14.1 months. The company said treatment was generally well tolerated, with most treatment-related adverse events grade 1/2 and no grade 4/5 common adverse events. Serious adverse reactions occurred in 35% of 140 patients; discontinuation due to adverse reactions occurred in 2.9%.

The approved label covers a broad advanced melanoma population after anti-PD-1 progression, including intratumoral administration into superficial, deep, and visceral lesions. Replimune said the confirmatory Phase 3 IGNYTE-3 trial of TUDRIQEV plus nivolumab is ongoing.