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INTerpath-001 was the first positive phase 3 trial of a personalised cancer vaccine, announced 19 August 2026.
INTerpath-001, also V940-001, trial NCT05933577 sponsored by Moderna and Merck and announced on 19 August 2026, was the first positive phase 3 trial of a personalised cancer vaccine, testing intismeran autogene plus pembrolizumab against pembrolizumab alone after resection of stage IIB to IV melanoma. It randomised 1,137 patients, met its primary recurrence-free survival endpoint and its key secondary distant metastasis-free survival endpoint with no new safety signals, and full data are expected at a late-2026 congress with filings to follow; sister trials run in lung, kidney, bladder and skin squamous cancers. It confirms the phase 2b KEYNOTE-942 signal, and whether the effect size justifies bespoke manufacturing for every patient is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,137 enrolled.
Met; hazard ratio and medians not yet disclosed (topline 19 August 2026).
SourceMet; numbers pending presentation.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Recurrence-free survivalprimary | Intismeran autogene + pembrolizumab | - | Met; hazard ratio and medians not yet disclosed (topline 19 August 2026). | - | - | link |
| Placebo + pembrolizumab | - | - | ||||
| Distant metastasis-free survival | Intismeran autogene + pembrolizumab | - | Met; numbers pending presentation. | - | - | - |
| Placebo + pembrolizumab | - | - |
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.
Shares KEYNOTE-942: a personalised mRNA cancer vaccine plus pembrolizumab after melanoma surgery, Moderna, Intismeran autogene, Stage III melanoma (after surgery).
Shares Intismeran autogene, Personalised neoantigen (mRNA) vaccines, Melanoma, Pembrolizumab.
Shares Moderna, Intismeran autogene, Personalised neoantigen (mRNA) vaccines, Melanoma.
Shares Moderna, Intismeran autogene, Personalised neoantigen (mRNA) vaccines, Melanoma.
Shares Stage IIB and IIC melanoma, Stage III melanoma (after surgery), Melanoma.
Shares Intismeran autogene, Personalised neoantigen (mRNA) vaccines, Pembrolizumab.
Shares Stage IIB and IIC melanoma, Stage III melanoma (after surgery), Melanoma.
Shares Stage IIB and IIC melanoma, Stage III melanoma (after surgery), Melanoma.