Merck and Moderna say personalized melanoma vaccine plus Keytruda met primary endpoint in Phase 3

Merck and Moderna announced topline Phase 3 INTerpath-001 results: intismeran autogene plus Keytruda beat Keytruda alone on recurrence-free survival in 1,137 patients with completely resected high-risk melanoma. Distant metastasis-free survival, a key secondary endpoint, was also met at a prespecified interim analysis. Merck shares jumped that session, but overall survival is still being followed and the release gives no effect size yet.

• Randomized 2:1 to intismeran plus Keytruda or Keytruda alone; 1,137 patients
• Primary endpoint recurrence-free survival met; distant metastasis-free survival met
• Phase 2b KEYNOTE-942 (5-year): RFS hazard ratio 0.51; DMFS hazard ratio 0.411
• Safety consistent with prior studies, no new safety signals