Moderna-Merck melanoma vaccine hits Phase 3 goals, shares surge

Merck and Moderna said August 19 that the Phase 3 INTerpath-001 trial of intismeran autogene (mRNA-4157) plus KEYTRUDA met both its primary endpoint of recurrence-free survival and its key secondary endpoint of distant metastasis-free survival in 1,137 patients with completely resected stage IIB-IV melanoma, the first positive Phase 3 result ever for an individualized mRNA neoantigen cancer therapy. Moderna shares surged as much as 90%+ intraday and Merck rose about 7-11%, and the companies said they plan to file for regulatory approval within months.