Adjuvant treatment with mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with Keytruda (pembrolizumab) demonstrated a statistically significant and clinically meaningful improvement in distant metastasis-free survival (DMFS) for patients with resected high-risk melanoma (stage III/IV) in a phase IIb study.
FDA has granted an accelerated approval to RP1 (vusolimogene oderparepvec) following the agency’s Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
