Merck and Moderna announced in August 2026 that their INTerpath-001 Phase 3 trial met its recurrence-free and distant-metastasis-free survival endpoints in patients whose high-risk melanoma had been completely removed. The trial tested personalized mRNA therapy intismeran with Keytruda against Keytruda alone.
What is known.
The August update described plans to present the data and speak with regulators about submissions rather than a completed US filing. The study also continues to evaluate other endpoints, including overall survival.
Why it is a possibility.
Two positive pivotal endpoints give a strong basis for seeking review, supporting a provisional 60% chance of a filing by June 2027.
The timetable remains less certain than an application already accepted by the FDA. Data maturation, manufacturing an individualized therapy and discussions about the filing package may take longer.
What could prevent it.
The companies may wait for more mature evidence or need additional manufacturing and regulatory work.
How it will be assessed.
Resolves YES if Merck or Moderna publicly confirms that it submitted a US FDA marketing application for intismeran autogene (V940/mRNA-4157) with pembrolizumab as adjuvant therapy after resection of high-risk melanoma by 30 June 2027. A trial result alone does not count.
Sources and primary records
Probabilities are provisional editorial estimates, not guarantees. Sources document the present evidence and resolution rule. Read the full disclaimer.