Results reported by

  • Merck & Co.
  • Moderna

Merck and Moderna reported positive topline results from a preplanned interim analysis of Phase 3 INTerpath-001 in patients with completely resected stage IIB-IV melanoma. The companies said intismeran autogene plus Keytruda met the primary recurrence-free survival endpoint and key secondary distant metastasis-free survival endpoint versus Keytruda alone. They did not disclose hazard ratios, absolute event rates, survival curves, or overall-survival data. The registered trial, NCT05933577, remains ongoing, and full results have not yet been presented.

What happened

  • Merck and Moderna said the Phase 3 INTerpath-001 interim analysis met its primary recurrence-free survival endpoint.
  • The companies also said the trial met the key secondary endpoint of distant metastasis-free survival.
  • No effect sizes or overall-survival results were disclosed, and the registered trial continues.

Why it matters

A positive randomized Phase 3 readout is an important late-stage test of an individualized neoantigen mRNA therapy, but the clinical magnitude cannot be judged until detailed results are available.

Key details

Trial
INTerpath-001, NCT05933577
Population
Completely resected stage IIB-IV melanoma
Comparison
Intismeran autogene plus Keytruda versus placebo plus Keytruda
Reported outcome
RFS and DMFS endpoints met at a preplanned interim analysis
Data status
Topline company report; no effect sizes or overall-survival data disclosed

What to watch

  • Hazard ratios, absolute event rates, follow-up duration, subgroup analyses, and detailed safety results at the planned medical presentation.
  • Overall-survival follow-up and the outcome of future regulatory discussions.

Event chronology

How the story developed

  1. Interim topline results reported

    Merck and Moderna reported that RFS and DMFS endpoints were met while the registered Phase 3 trial continues.

Evidence ledger

Sources behind this brief

  1. 01
    Primary source

    Merck and Moderna Phase 3 topline announcement

    company reported result · Accessed August 22, 2026

  2. 02
    Supporting context

    ClinicalTrials.gov record NCT05933577

    primary source · Accessed August 22, 2026

  3. 03
    Supporting context

    Fierce Biotech independent coverage

    independent reporting · Accessed August 22, 2026

  4. 04
    Supporting context

    Associated Press independent coverage

    independent reporting · Accessed August 22, 2026