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    Intismeran autogene (mRNA-4157/V940)

    Also known as mRNA-4157, V940, intismeran, individualized neoantigen therapy

    Intismeran autogene is an individualized mRNA cancer therapy that encodes up to 34 neoantigens from a patient's own tumour, given with the immunotherapy pembrolizumab.[1] In August 2026 it became the first mRNA cancer treatment with a positive late-stage trial, the phase 3 INTerpath-001 study in resected melanoma.[2][3]

    Editor reviewedStrict sourcingUpdated mRNA and next-gen vaccinesHealth and medicineLife sciences
    Key facts

    Intismeran autogene (also called mRNA-4157 or V940) is a personalised mRNA cancer therapy developed by Moderna and Merck. It is given alongside the immunotherapy drug pembrolizumab.[3] It matters because, in August 2026, it gave the first positive late-stage result for any mRNA-based cancer treatment and for any individualized neoantigen therapy.[2]

    How it works

    Each patient’s tumour is sequenced to find its mutations. A synthetic mRNA is then made that encodes up to 34 neoantigens, the mutated protein fragments unique to that tumour.[1] The mRNA platform is the same basic technology as mRNA vaccines against infections. See how mRNA vaccines work.[4]

    Phase 3 results

    INTerpath-001 enrolled 1,137 patients with completely resected stage IIB-IV melanoma. They were randomized 2:1 to intismeran plus pembrolizumab or to pembrolizumab alone.[5] Intismeran was given at 1 mg every three weeks for up to nine doses, with pembrolizumab every six weeks, for about a year. Overall survival is among the secondary endpoints still being followed.[6] On 19 August 2026, Merck and Moderna reported that the trial met its primary endpoint, recurrence-free survival. It also met a key secondary endpoint, distant metastasis-free survival.[3] The companies reported safety consistent with earlier studies and no new safety signals.[7] The data were to be presented at a medical meeting and shared with regulators.[8]

    The trial is sponsored by Merck Sharp & Dohme, began in July 2023 and is active but no longer recruiting.[9] It builds on the phase 2b KEYNOTE-942 trial. Five-year results presented at ASCO 2026 showed a 49% lower risk of recurrence or death with the combination than with pembrolizumab alone (HR 0.51).[10] The risk of distant metastasis or death was 59% lower (HR 0.411).[11]

    Reading the evidence

    The phase 3 announcement came from the companies. It reported that the trial met its endpoints and gave no new safety signals, and peer-reviewed publication and full presentation were still to come.[3][7][8] The comparator arm received pembrolizumab, an active standard treatment, so the result measures the added effect of the mRNA therapy.[5] The earlier five-year effect estimate comes from a smaller phase 2b trial, KEYNOTE-942.[10]

    Why mRNA suits personalised vaccines

    mRNA is made by cell-free in vitro transcription, which gives high yields and allows rapid production.[12] That matters when every patient needs a different sequence, here up to 34 neoantigens per patient.[1]

    Competitors and context

    BioNTech, working with Genentech, is testing its own individualized mRNA vaccine, autogene cevumeran. A phase 2 trial of about 260 patients is under way in resected pancreatic cancer.[13] See BioNTech. Both belong to the wider class of personalized-neoantigen-vaccines, explained in how cancer vaccines work.[1][13]

    Intismeran’s own programme extends beyond melanoma. As of July 2026 Moderna reported nine phase 2 and phase 3 trials across melanoma, non-small cell lung cancer, bladder cancer and kidney cancer. They include a phase 3 study in high-risk stage 1 lung cancer.[14]

    What to watch

    The key next steps are the full INTerpath-001 data presentation and any regulatory filings.[8]

    This page describes trial evidence and regulatory status. It is not medical advice.

    Questions readers ask

    What is intismeran autogene?

    A synthetic mRNA tailored to each patient that encodes up to 34 neoantigens identified from the patient's own tumour.[1]

    What did the phase 3 trial show?

    Merck and Moderna reported in August 2026 that INTerpath-001 met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival versus pembrolizumab alone, with no new safety signals.[3][7]

    Is intismeran approved?

    Not as of the August 2026 announcement. The companies said the data would be presented at a medical meeting and shared with regulatory authorities.[8]

    Sources

    Each numbered claim is a statement we checked against the sources listed with it. Status shows how well established it is.

    1. [1]

      Each intismeran dose is a synthetic mRNA encoding up to 34 neoantigens chosen from the mutations in that patient's own tumour. confirmedas of 2026-08-19

    2. [2]

      INTerpath-001 was described as the first positive late-stage result for an mRNA-based cancer treatment and for an individualized neoantigen therapy. confirmedas of 2026-08-19

    3. [3]

      On 19 August 2026 Merck and Moderna reported that the phase 3 INTerpath-001 trial of intismeran autogene plus pembrolizumab met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival in resected high-risk melanoma. confirmedas of 2026-08-19

    4. [4]

      Two major types of RNA are studied as vaccines, non-replicating mRNA and virally derived self-amplifying RNA. confirmedas of 2018-01-12

    5. [5]

      INTerpath-001 randomized 1,137 patients with completely resected stage IIB-IV melanoma 2:1 to intismeran plus pembrolizumab or pembrolizumab alone. confirmedas of 2026-08-19

    6. [6]

      In INTerpath-001, patients received intismeran at 1 mg every three weeks for up to nine doses plus pembrolizumab 400 mg every six weeks for up to nine cycles, or pembrolizumab alone, for about a year; overall survival is among the secondary endpoints still being followed. confirmedas of 2026-08-19

    7. [7]

      The companies reported that safety in INTerpath-001 was consistent with earlier studies of the combination, with no new safety signals. confirmedas of 2026-08-19

    8. [8]

      Merck and Moderna said the INTerpath-001 data would be presented at a medical meeting and shared with regulatory authorities; no approval decision had been announced as of the announcement. confirmedas of 2026-08-19

    9. [9]

      INTerpath-001 (NCT05933577) is sponsored by Merck Sharp & Dohme, began in July 2023 and is listed as active, not recruiting. confirmedas of 2026-10-10

    10. [10]

      Five-year results from the earlier phase 2b KEYNOTE-942 trial, presented at ASCO 2026, showed a 49% lower risk of recurrence or death with intismeran plus pembrolizumab than with pembrolizumab alone (HR 0.51). confirmedas of 2026-08-19

    11. [11]

      In the five-year KEYNOTE-942 follow-up, intismeran plus pembrolizumab also reduced the risk of distant metastasis or death by 59% compared with pembrolizumab alone (HR 0.411). confirmedas of 2026-08-19

    12. [12]

      mRNA vaccines can potentially be manufactured rapidly, cheaply and at scale, mainly because in vitro transcription reactions give high yields. confirmedas of 2018-01-12

    13. [13]

      BioNTech's individualized mRNA cancer vaccine autogene cevumeran is being tested with Genentech in a phase 2 trial of about 260 patients with resected pancreatic cancer, with disease-free survival as the primary outcome. confirmedas of 2026-10-10

    14. [14]

      As of July 2026 Moderna and Merck had nine phase 2 and phase 3 trials of intismeran under way across melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma, including a phase 3 study in high-risk stage 1 lung cancer (company-reported). confirmedas of 2026-07-31

    Revision history (2)
    1. Page created.
    2. Added INTerpath-001 dosing, the five-year distant-metastasis result from KEYNOTE-942, the wider trial programme and links to cancer-immunotherapy pages.

    Created Oct 10, 2026. Last reviewed by an editor on Oct 10, 2026. Next scheduled review: Jan 10, 2027.

    Cite this page

    "Intismeran autogene (mRNA-4157/V940)." ContentLora, updated Oct 10, 2026. https://contentlora.com/wiki/intismeran-autogene

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