Merck and Moderna's Intismeran Plus KEYTRUDA Shows Promising Results in Phase 3 Melanoma Trial

Merck and Moderna have announced positive topline results from their Phase 3 INTerpath-001 trial evaluating intismeran autogene in combination with KEYTRUDA as an adjuvant treatment for patients with completely resected Stage IIB-IV melanoma.

The trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival, producing statistically significant and clinically meaningful improvements compared to KEYTRUDA alone at a pre-specified interim analysis.

This marks the first positive Phase 3 readout for an individualized neoantigen therapy and the first positive Phase 3 readout for an mRNA-based cancer therapy, with INTerpath-001 also demonstrating a clinically meaningful improvement over KEYTRUDA alone in the adjuvant setting for patients with resected melanoma.

The study evaluated 1,137 patients with completely resected Stage IIB, IIC, III or IV cutaneous melanoma who had not previously received systemic therapy and showed that the combination of intismeran and KEYTRUDA reduced the risk of recurrence or death by approximately 49% and distant metastasis or death by about 59% compared to KEYTRUDA alone in earlier findings from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study.