Replimune presents RP1+nivolumab data at FDA advisory committee for advanced melanoma BLA

Replimune Group, Inc.

RP1 (vusolimogene oderparepvec) + nivolumab BLA resubmission discussed at FDA advisory committee on July 30, 2026.
IGNYTE trial ORR 33.6% (95% CI: 25.8-42), CR 16.4%, median DoR 24.8 months in anti-PD-1 failed advanced melanoma.
Safety profile: mainly Grade 1-2, no treatment-related Grade 5 events; 7.9% discontinued RP1 due to TEAE.
FDA clinical review initially recommended accelerated approval; committee to address response assessment and contribution of effect.
Unmet need: only lifileucel (AMTAGVI) approved post anti-PD-1; RP1 offers single-arm data with durable responses.

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