Intismeran Plus Pembrolizumab Meets Melanoma Endpoints

Merck and Moderna reported that the phase 3 INTerpath-001 trial met its primary endpoint of recurrence-free survival (RFS) and key secondary endpoint of distant metastasis-free survival (DMFS). The company-reported topline findings evaluated adjuvant intismeran autogene, an investigational individualized neoantigen therapy jointly developed by the companies, plus pembrolizumab (Keytruda, Merck) in patients with completely resected stage IIB-IV melanoma.

INTerpath-001 is a randomized, double-blind, placebo- and active-comparator-controlled global trial that enrolled 1,137 patients with high-risk resected cutaneous melanoma. After complete resection, participants were randomized 2:1 to intismeran 1mg every 3 weeks for up to 9 doses plus pembrolizumab 400mg every 6 weeks for up to 9 cycles, or pembrolizumab alone for approximately 1 year. Treatment was planned until recurrence, unacceptable toxicity, or a maximum of approximately 56 weeks, whichever came first.

At a prespecified interim analysis, combination therapy produced statistically significant and clinically meaningful improvements in RFS and DMFS versus pembrolizumab alone, according to the companies. The analysis included patients with completely resected stage IIB, IIC, III, or IV cutaneous melanoma who had received no prior systemic therapy. RFS was defined as the time from randomization to investigator-assessed local, locoregional, regional, or distant recurrence, or death from any cause.

The companies said the combination’s safety profile was consistent with that observed in previously reported studies, with no new safety signals. The trial will continue to assess other key secondary endpoints, including overall survival, safety, tolerability, and quality of life.

Intismeran is designed from an individual patient’s tumor sample to identify its unique mutational signature and generate an antitumor immune response. Each therapy contains synthetic messenger RNA encoding up to 34 neoantigens. Merck and Moderna said the data will be presented at an upcoming international medical meeting and shared with regulatory authorities.

Source:  Merck & Co., Inc., and Moderna, Inc. Phase 3 INTerpath-001 results for intismeran autogene plus Keytruda in resected stage IIB-IV melanoma. News release. Merck & Co., Inc.; August 19, 2026. Accessed August 19, 2026.