Oncolytic virotherapy RP1 plus nivolumab approved for anti-PD-1-refractory melanoma (ORR 32.9% in IGNYTE)

The FDA granted accelerated approval to vusolimogene oderparepvec (RP1, Tudriqev) combined with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed on an anti-PD-1 antibody-based regimen — a group with very limited options. In the IGNYTE trial (Journal of Clinical Oncology, n=140, independent central review by RECIST 1.1) the confirmed objective response rate was 32.9% (95% CI, 25.2-41.3), including 15.0% complete responses, with a median duration of response of 33.7 months (95% CI, 14.1 to not reached); overall survival was 75.3% at 1 year and 63.3% at 2 years. Responses also occurred in non-injected lesions, including visceral ones, and treatment-related adverse events were mostly grade 1/2 (77.1%), with 9.3% grade 3 and 3.6% grade 4 and no grade 5 events. The approval is accelerated and rests on response rate and duration, so continued approval depends on a confirmatory trial.