Merck and Moderna Announce Phase 3 INTerpath-001 Trial of Intismeran Autogene Plus KEYTRUDA® Met Endpoints of Recurrence-Free Survival (RFS) and Distant Metastasis-Free Survival (DMFS) in Patients With Completely Resected Stage IIB-IV Melanoma - Merck.com
- Merck and Moderna announced that their Phase 3 INTerpath-001 trial met primary endpoints for recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with completely resected stage IIB-IV melanoma.
- The study found that combining KEYTRUDA with intismeran autogene—an mRNA-based individualized neoantigen therapy tailored to a patient's specific tumor mutations—provided statistically significant improvements over using KEYTRUDA alone.
- This marks the first and only combination regimen to demonstrate such clinically meaningful improvements in the adjuvant melanoma setting.
- The companies intend to present the full data at an upcoming international medical meeting and will begin engaging with regulators regarding filing submissions for the combination therapy.
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