Moderna, Merck Post Positive Phase 3 Melanoma Data in 1,137-Patient AI-Personalized Therapy Trial
Updated
Updated · Fox News · Sep 14
Moderna, Merck Post Positive Phase 3 Melanoma Data in 1,137-Patient AI-Personalized Therapy Trial
3 articles · Updated · Fox News · Sep 14
Summary
Moderna and Merck said their Phase 3 trial in 1,137 patients with surgically removed high-risk melanoma met its main recurrence-free survival goal and a key distant metastasis-free survival endpoint.
The treatment, intismeran autogene (V940 or mRNA-4157), is built from each patient's tumor mutations, with algorithms selecting targets for an mRNA therapy that can encode up to 34 neoantigens and is given with Keytruda.
The companies called it the first positive Phase 3 readout for an individualized neoantigen therapy and for an mRNA-based cancer therapy, but only topline results have been released and the study is still tracking overall survival.
Earlier Phase 2b data in a smaller group showed the combination cut recurrence or death risk by 49% and distant metastasis or death by 59% versus Keytruda alone, while the therapy remains investigational and not FDA-approved.