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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.
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.
Tumour/normal WES → neoantigen prediction → single mRNA encoding up to 34 neoepitopes in LNP → intramuscular dosing with pembrolizumab.
1.Tumour and normal DNA are sequenced; up to 34 patient-specific neoantigens are predicted
Source: clinicaltrials.gov/study/NCT05933577. Doses are for orientation; the current label governs.
The sponsors said filings would follow the positive topline result of August 2026 and the full data presentation. Timing is our estimate. Source
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Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Investigational; BLA expected 2026-27 after INTerpath-001 | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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For the first time a randomised trial suggests that a vaccine tailored to an individual's tumour can reduce relapse when combined with immunotherapy, which is a proof of concept for a field that had failed for decades. Nothing changes for patients yet: the trial was small, the confidence interval crossed one, and the phase 3 trial in melanoma (and parallel trials in lung and other cancers) must confirm it. If it does, personalised mRNA vaccines could become a routine adjunct to checkpoint inhibitors after surgery.
Pancreatic cancer was thought to be immunologically inert because of its low mutation burden; this study showed that with the right vaccine platform its few neoantigens can still be targeted. It is the strongest human evidence so far that personalised cancer vaccines can generate durable, tumour-specific immunity, and it justifies the randomised trials now running in pancreatic cancer and melanoma. Benefit is not yet proven, because responders may simply have had more immunogenic tumours.
Query for this drug: (TITLE:"Intismeran autogene" OR ABSTRACT:"Intismeran autogene" OR TITLE:"V940" OR ABSTRACT:"V940" OR TITLE:"mRNA-4157" OR ABSTRACT:"mRNA-4157" OR TITLE:"personalised cancer vaccine PCV" OR ABSTRACT:"personalised cancer vaccine PCV" OR TITLE:"individualised neoantigen therapy INT" OR ABSTRACT:"individualised neoantigen therapy INT") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Intismeran autogene, not a curated reading list.
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