Replimune Group, Inc. — Form 8-K

Replimune presented to FDA advisory committee on July 30, 2026, seeking accelerated approval of vusolimogene oderparepvec-wtpg (TUDRIQEV/RP1) combined with nivolumab for unresectable advanced cutaneous melanoma in patients with disease progression on anti-PD-1 therapy. The IGNYTE Phase 2 trial (N=140) showed 33.6% ORR (95% CI: 25.8-42%) with median duration of response of 24.8 months; median OS 32.9 months (3-year OS rate 47.8%). Safety profile was manageable with mainly Grade 1-2 adverse events and no treatment-related Grade 5 deaths in the melanoma cohort. FDA clinical reviewers recommended approval on July 15, 2025, noting the 33.6% ORR was substantially higher than the 5-7% expected with further anti-PD-1 monotherapy, and superior to lifileucel (AMTAGVI, 31.5% ORR with 7.5% treatment-related mortality).