- First mRNA cancer vaccine with PD-1 inhibitor saw positive Phase 3 data
- First positive Phase 3 readout for an individualised neoantigen therapy and for an mRNA-based cancer therapy
- First Phase 3 study to demonstrate clinically meaningful improvements over standard-of-care KEYTRUDA
- Personalised cancer therapy could become a viable treatment option
- Potential launch in 2027
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Cancer vaccine sees breakthrough. On 19 Aug 2026, Moderna and Merck announced positive results from the Phase 3 INTerpath-001 trial which evaluated Intismeran, which is a personalised mRNA-based therapy (INT) combined with Merck’s anti-PD-1 therapy (KEYTRUDA), in patients with completely resected stage IIB-IIV melanoma. It met its primary recurrence-free survival (RFS) endpoint and a key secondary distant metastasis-free survival (DMFS) endpoint in 1,137 patients. This represents the first positive Phase 3 readout for an individualised neoantigen therapy and for an mRNA-based cancer therapy, as well as being the first Phase 3 study to demonstrate clinically meaningful improvements over KEYTRUDA alone, which is a standard-of-care immunotherapy.
Validation of mRNA beyond infectious diseases. Unlike Covid vaccines (which is a well-known example of a mRNA-based therapy), Intismeran is a personalised therapy where each patient’s cancer tumour is sequenced to identify unique mutations. Then, an individualised mRNA therapy with selected tumour neoantigens encoded is manufactured and will train the immune system to recognise residual cancer cells. This is combined with KEYTRUDA, which blocks the PD-1 pathway to help prevent cancer cells from hiding, generates a stronger and more targeted anti-tumour response. This provides strong evidence that mRNA can become a viable therapeutic platform in oncology.
Potential launch in 2027. Moderna has guided that positive Phase 3 data could support an Intismeran launch in 2027. The asset is currently being studied across Phase 2/3 trials in lung, kidney, bladder and other cancers. Competition is also increasing, with BioNTech and Roche’s individualised mRNA platforms currently in development.
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