INTerpath-001 (V940-001)
INTerpath-001 was the first positive phase 3 trial of a personalised cancer vaccine, announced 19 August 2026.
1,137 patients. Met primary endpoint of recurrence-free survival and key secondary of distant-metastasis-free survival; no new safety signals. Full data expected at a late-2026 congress; filings to follow. Sister trials in NSCLC (INTerpath-002), RCC, bladder, and CSCC.
- Numbers are not recorded here for this endpoint. Intismeran autogene + pembrolizumab: Met; hazard ratio and medians not yet disclosed (topline 19 August 2026).; Placebo + pembrolizumab.
- Numbers are not recorded here for this endpoint. Intismeran autogene + pembrolizumab: Met; numbers pending presentation.; Placebo + pembrolizumab.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Adjuvant resected stage IIB-IV melanoma: intismeran autogene + pembrolizumab vs pembrolizumab. People in a different situation may not see the same effect.
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 participants 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.