{"entity":{"id":"intismeran-autogene","kind":"drug","name":"Intismeran autogene","aka":["mRNA-4157","V940","personalised cancer vaccine (PCV)","individualised neoantigen therapy (INT)"],"tldr":"A custom mRNA vaccine encoding up to 34 of a patient's own tumour mutations. In August 2026 it became the first personalised cancer vaccine to win a phase 3 trial.","summary":"Intismeran is developed by Moderna and Merck. Phase 2b KEYNOTE-942 showed 49% reduction in recurrence or death with pembrolizumab in resected melanoma. Phase 3 INTerpath-001 (1,137 patients, stage IIB-IV resected melanoma) met RFS and DMFS endpoints (19 August 2026); regulatory filings expected. Phase 3 trials in adjuvant NSCLC (INTerpath-002), RCC, bladder, and cutaneous SCC ongoing. Manufacturing ~6 weeks per patient.","status":"phase-3","asOf":"2026-09-04","links":[{"label":"Merck/Moderna announcement","url":"https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/"}],"tags":[],"related":[],"cancers":["melanoma","nsclc","rcc","urothelial","stage-iii-melanoma","stage-ii-melanoma"],"sections":[],"technologies":["neoantigen-mrna-vaccine"],"targets":[],"drugs":["pembrolizumab"],"companies":["moderna","merck"],"institutions":[],"pathways":[],"terms":[],"trials":["interpath-001","nct06077760","nct07513376","nct03897881","nct07221474","nct06307431","nct06961006","nct06623422","nct06305767","nct06833073"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"V940, mRNA-4157","modality":"Personalised mRNA neoantigen vaccine","mechanism":"Tumour/normal WES → neoantigen prediction → single mRNA encoding up to 34 neoepitopes in LNP → intramuscular dosing with pembrolizumab.","approvals":[],"mechanismSteps":["Tumour and normal DNA are sequenced; up to 34 patient-specific neoantigens are predicted","A single mRNA encoding those neoantigens is manufactured (~6 weeks) and packaged in lipid nanoparticles","Injected mRNA is translated by dendritic cells, which present the neoantigens","Neoantigen-specific T cells are primed and expanded","Pembrolizumab keeps those T cells active against residual tumour cells","Recurrence is prevented or delayed"],"dosing":{"route":"Intramuscular injection","schedule":"1 mg every 3 weeks for up to 9 doses, with pembrolizumab 200 mg every 3 weeks for up to 18 cycles","monitoring":"Injection-site and systemic reactions; immune-related events from pembrolizumab","source":"https://clinicaltrials.gov/study/NCT05933577"},"toxicity":[{"event":"Fatigue"},{"event":"Injection-site pain"},{"event":"Chills"},{"event":"Pyrexia"},{"event":"Myalgia"},{"event":"Headache"}],"access":[{"country":"US","reimbursement":"Investigational; BLA expected 2026-27 after INTerpath-001","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2023-02-22","type":"designation","region":"US","note":"Breakthrough Therapy designation, adjuvant melanoma","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2023-04","type":"designation","region":"EU","note":"PRIME designation","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-08-19","type":"filing","region":"US","note":"Phase 3 INTerpath-001 met RFS and DMFS endpoints; filings to follow","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/intismeran-autogene/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"},{"id":"stage-ii-melanoma","kind":"cancer","name":"Stage IIB and IIC melanoma","route":"/cancers/stage-ii-melanoma/"},{"id":"stage-iii-melanoma","kind":"cancer","name":"Stage III melanoma (after surgery)","route":"/cancers/stage-iii-melanoma/"}],"technology":[{"id":"mrna-lnp-manufacturing","kind":"technology","name":"mRNA and lipid nanoparticle manufacturing","route":"/technologies/mrna-lnp-manufacturing/"},{"id":"neoantigen-mrna-vaccine","kind":"technology","name":"Personalised neoantigen (mRNA) vaccines","route":"/technologies/neoantigen-mrna-vaccine/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"},{"id":"moderna","kind":"company","name":"Moderna","route":"/companies/moderna/"}],"trial":[{"id":"nct06833073","kind":"trial","name":"A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)","route":"/trials/nct06833073/"},{"id":"nct06961006","kind":"trial","name":"A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)","route":"/trials/nct06961006/"},{"id":"nct06305767","kind":"trial","name":"A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)","route":"/trials/nct06305767/"},{"id":"nct07513376","kind":"trial","name":"A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I ","route":"/trials/nct07513376/"},{"id":"nct06307431","kind":"trial","name":"A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).","route":"/trials/nct06307431/"},{"id":"nct06077760","kind":"trial","name":"A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (","route":"/trials/nct06077760/"},{"id":"nct07221474","kind":"trial","name":"A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)","route":"/trials/nct07221474/"},{"id":"nct06623422","kind":"trial","name":"A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)","route":"/trials/nct06623422/"},{"id":"nct03897881","kind":"trial","name":"An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYN","route":"/trials/nct03897881/"},{"id":"interpath-001","kind":"trial","name":"INTerpath-001 (V940-001)","route":"/trials/interpath-001/"}],"term":[{"id":"vaccines-and-oncolytic-viruses","kind":"term","name":"Cancer vaccines and oncolytic viruses","route":"/terms/vaccines-and-oncolytic-viruses/"},{"id":"neoantigen","kind":"term","name":"Neoantigen","route":"/terms/neoantigen/"}],"pairing":[{"id":"vaccine-plus-pd1","kind":"pairing","name":"Personalised neoantigen vaccine + PD-1 blockade","route":"/pairings/vaccine-plus-pd1/"}],"person":[{"id":"jeffrey-weber","kind":"person","name":"Jeffrey S. Weber","route":"/people/jeffrey-weber/"}],"bottleneck":[{"id":"b-tme-immunosuppression","kind":"bottleneck","name":"Cold tumours and the immunosuppressive microenvironment","route":"/bottlenecks/b-tme-immunosuppression/"}],"idea":[{"id":"idea-moon-neoantigen-vaccines-at-scale","kind":"idea","name":"Personalised cancer vaccines at commodity cost through fully automated manufacturing","route":"/ideas/idea-moon-neoantigen-vaccines-at-scale/"},{"id":"idea-bio2-mrd-triggered-neoantigen-vaccine","kind":"idea","name":"Personalised vaccines given only when the blood test turns positive","route":"/ideas/idea-bio2-mrd-triggered-neoantigen-vaccine/"},{"id":"idea-neoantigen-immunogenicity-rules","kind":"idea","name":"What makes a neoantigen actually immunogenic?","route":"/ideas/idea-neoantigen-immunogenicity-rules/"}],"paper":[{"id":"paper-keynote-942-lancet-2024","kind":"paper","name":"KEYNOTE-942: a personalised mRNA cancer vaccine plus pembrolizumab after melanoma surgery","route":"/key-papers/paper-keynote-942-lancet-2024/"},{"id":"paper-rojas-mrna-neoantigen-vaccine-pancreatic-nature-2023","kind":"paper","name":"Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer","route":"/key-papers/paper-rojas-mrna-neoantigen-vaccine-pancreatic-nature-2023/"}],"pathway":[{"id":"cancer-immunity-cycle","kind":"pathway","name":"The cancer-immunity cycle","route":"/pathways/cancer-immunity-cycle/"}]}}