Merck Moderna Melanoma Vaccine Meets Topline Goals
Merck Moderna melanoma vaccine met primary and key secondary endpoints; companies will present data and engage regulators, creating a filing catalyst.
KEY TAKEAWAYS
- A pre-specified interim analysis of Phase 3 INTerpath-001 met the primary RFS and key secondary DMFS endpoints.
- The trial enrolled 1,137 patients with resected stage IIB-IV melanoma and randomized them 2:1 to intismeran plus Keytruda.
- Merck and Moderna plan medical-meeting data presentations and regulatory engagement on filing submissions.
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Merck and Moderna said on Aug. 19, 2026, that their melanoma vaccine met its Phase 3 primary and a key secondary endpoint, marking the first Phase 3 validation of an individualized mRNA cancer therapy.
INTerpath‑001 Trial Meets Endpoints
A pre-specified interim analysis of the Phase 3 INTerpath‑001 trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS). The trial enrolled 1,137 patients with completely resected stage IIB–IV cutaneous melanoma who had not received prior systemic therapy. Patients were randomized 2:1 to receive the personalized vaccine plus Merck’s Keytruda (pembrolizumab) or Keytruda alone in a randomized, double-blind, placebo- and active-comparator-controlled design. The study is registered as ClinicalTrials.gov NCT05933577.
The trial evaluated the combination as adjuvant therapy, given after surgery to patients at high risk of recurrence.
Therapy Details and Next Steps
The therapy, intismeran autogene (also called intismeran; V940/mRNA‑4157), is an individualized neoantigen mRNA therapy designed to target the unique mutational profile of each patient’s tumor. It is jointly developed by Merck and Moderna.
In the trial, intismeran was administered at 1 mg every three weeks for up to nine doses alongside Keytruda at 400 mg every six weeks for up to nine cycles. Treatment continued until recurrence, unacceptable toxicity, or about 56 weeks.
Merck and Moderna said they plan to present detailed INTerpath‑001 data at an upcoming international medical meeting and will engage with regulators on filing submissions. The study will continue to follow patients for other key secondary endpoints, including overall survival.
Moderna’s Q2 2026 earnings call referenced earlier Phase 2 results showing a 49% reduction in risk of recurrence or death over five years with intismeran plus Keytruda, providing context for the program’s development.
"The trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS)," the companies said in their press release.
