Moderna & Merck: First Positive Phase 3 for mRNA Cancer Therapy in Melanoma
Original: Moderna reports first positive Phase 3 for mRNA neoantigen therapy in melanoma
Why This Matters
This is the first Phase 3 validation of personalized mRNA cancer therapy, potentially opening a new treatment class in oncology.
Moderna and Merck announced positive Phase 3 topline results from the INTerpath-001 trial for intismeran autogene, an individualized mRNA-based neoantigen therapy combined with KEYTRUDA, in patients with completely resected stage IIB-IV melanoma. The study met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival.
On August 19, 2026, Moderna and Merck announced positive topline results from the Phase 3 INTerpath-001 trial evaluating adjuvant treatment with intismeran autogene — a novel investigational mRNA-based individualized neoantigen therapy jointly developed by the two companies — in combination with Merck's KEYTRUDA (pembrolizumab). The trial enrolled patients with completely resected stage IIB-IV melanoma. The study met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS). This marks the first positive Phase 3 result for any individualized neoantigen therapy, and the first Phase 3 success for an mRNA-based cancer therapy. Moderna co-founder and Flagship Pioneering CEO Noubar Afeyan noted in a statement on X that when Moderna was founded in 2010, 'the idea that mRNA could become a new class of medicines was outright rejected,' and that using mRNA to build therapies around a patient's unique tumor mutations was 'even further from reality.' Intismeran autogene is designed to target neoantigens — mutations specific to an individual patient's tumor — representing a personalized oncology approach. Full data are expected to be shared at an upcoming medical conference.