intismeran autogene (intismeran; V940 or mRNA-4157) with KEYTRUDA (pembrolizumab) - (INTerpath-001)

August 19, 2026: Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) reported positive topline results from the Phase 3 INTerpath-001 trial of intismeran autogene (V940/mRNA-4157) plus KEYTRUDA (pembrolizumab) in patients with completely resected stage IIB-IV cutaneous melanoma in the adjuvant setting.

At a pre-specified interim analysis, the combination met the primary endpoint of recurrence-free survival (RFS) and the key secondary endpoint of distant metastasis-free survival (DMFS), showing statistically significant and clinically meaningful improvement versus KEYTRUDA alone. The study enrolled 1,137 patients randomized 2:1; treatment was intismeran 1 mg every 3 weeks for up to nine doses plus KEYTRUDA 400 mg every 6 weeks for up to nine cycles, versus KEYTRUDA alone. Safety was consistent with prior studies, with no new safety signals.

The trial will continue to assess other key secondary endpoints, including overall survival. The companies said they plan to present the data at an upcoming international medical meeting and engage regulators on filing submissions for intismeran in combination with KEYTRUDA.

The release also cites prior Phase 2b KEYNOTE-942/mRNA-4157-P201 five-year data presented at the 2026 ASCO Annual Meeting: 49% reduction in risk of recurrence or death (HR 0.51; 95% CI 0.294-0.887) and 59% reduction in risk of distant metastasis or death (HR 0.411; 95% CI 0.200-0.843) versus KEYTRUDA alone.