At a Glance
- Company: Merck and Moderna
- Location: United States
- Deal value: Not disclosed
- Focus area: Personalised mRNA cancer immunotherapy
- Next steps: The companies will analyse the data and discuss regulatory submissions with health authorities
What happened?
Merck and Moderna announced positive results from the pivotal Phase 3 INTerpath-001 trial evaluating intismeran autogene, also known as V940 or mRNA-4157. The personalised mRNA neoantigen therapy was tested with Merck’s Keytruda in patients with completely resected stage IIB–IV melanoma.
The trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival.
Why does it matter?
The result is a milestone for personalised cancer vaccines. It is the first positive Phase 3 readout for an individualised neoantigen therapy and an mRNA-based cancer treatment, according to the companies.
The combination also showed a clinically meaningful improvement over Keytruda alone, potentially supporting a new adjuvant treatment approach for patients at high risk of melanoma recurrence.
Who’s behind it?
Moderna developed the mRNA-based platform, while Merck contributes Keytruda and leads the collaboration’s oncology development strategy. The companies are jointly developing intismeran autogene across several cancer types.
How was it achieved?
Intismeran autogene is designed from the individual mutational profile of a patient’s tumour. Its synthetic mRNA encodes up to 34 neoantigens selected to stimulate an immune response against tumour-specific markers.
In INTerpath-001, patients received the vaccine with Keytruda after surgery, with outcomes compared with Keytruda alone.
What’s next?
The companies will continue follow-up analyses and engage regulatory authorities on the results. The Phase 3 programme is also being expanded across other tumour types, including non-small-cell lung cancer, bladder cancer and renal cell carcinoma.