IGNYTE: an engineered herpes virus with nivolumab in melanoma that had already failed anti-PD-1 therapy

Registrational cohort of 140 patients with advanced melanoma and confirmed progression on anti-PD-1 therapy given as the last prior treatment for at least eight weeks. Vusolimogene oderparepvec, a herpes simplex virus type 1-based oncolytic immunotherapy, was given into tumours for up to eight doses of up to 10 mL, with nivolumab for up to two years. The objective response rate was assessed by independent central review.

Confirmed objective response rate was 32.9 per cent (95% CI 25.2 to 41.3), with complete response in 15.0 per cent. Responses occurred with similar frequency, depth, duration and timing in injected and uninjected lesions, including visceral ones, which is the evidence for a systemic effect rather than a local one. Median duration of response was 33.7 months. Overall survival was 75.3 per cent at one year and 63.3 per cent at two. Treatment-related adverse events were grade 1 or 2 in 77.1 per cent, grade 3 in 9.3 per cent and grade 4 in 3.6 per cent, with no grade 5 events. 65.7 per cent had primary resistance to anti-PD-1 therapy and 46.4 per cent had received both anti-PD-1 and anti-CTLA-4 therapy.