Key Summary
- GlobalData projects sales of Moderna and MSD’s personalised mRNA cancer vaccine, intismeran autogene, will surpass $1bn by 2031.
- The forecast follows positive topline results from the Phase 3 INTerpath-001 study in high-risk resected melanoma, where intismeran plus Keytruda met primary recurrence-free survival endpoints.
- Beyond melanoma, Moderna is running three simultaneous Phase 3 trials in non-small cell lung cancer, marking its largest commercial target.
Sales of Moderna and MSD’s personalised cancer vaccine, intismeran autogene, are projected to surpass $1 billion (£760m) by 2031, according to analytics firm GlobalData.
Recently, the vaccine passed a Phase 3 clinical win in high-risk resected melanoma.
The investigational individualised neoantigen therapy (INT), administered alongside MSD’s PD-1 inhibitor Keytruda (pembrolizumab), met its primary endpoint of statistically significant recurrence-free survival (RFS) and its key secondary endpoint of distant metastasis-free survival (DMFS) in the Phase 3 INTerpath-001 trial.
The readout builds on five-year Phase 2 follow-up data, which demonstrated a 49% reduction in the risk of recurrence or death compared to Keytruda monotherapy.
Intismeran autogene is tailored to individual patients by sequencing resected tumour tissue to identify up to 34 unique mutations.
Moderna synthesises a custom mRNA sequence that primes the patient's T cells to target residual malignant cells, while Keytruda prevents tumours from suppressing immune activity.
According to GlobalData’s Melanoma: Epidemiology Forecast to 2035 report, approximately one-third of the 112,431 adults diagnosed with melanoma in the US in 2025 fall into the high-risk stage II–IV category targeted by the therapy.
Israel Stern, Healthcare Senior Analyst at GlobalData, noted that while melanoma provides the initial clinical proof of concept, Moderna’s largest commercial focus is lung cancer:
"While melanoma is thus far the proof of concept, it is lung cancer that appears to be where Moderna is placing its largest bet."
Intismeran autogene is currently being evaluated across three simultaneous Phase 3 non-small cell lung cancer (NSCLC) studies:
- INTerpath-002: Evaluating adjuvant treatment with pembrolizumab following standard chemotherapy.
- INTerpath-009: Assessing adjuvant therapy in patients without a pathological complete response following neoadjuvant pembrolizumab and chemotherapy.
- INTerpath-014: Testing an adjuvant co-formulation with subcutaneous pembrolizumab in high-risk stage I disease.
Moderna is also developing an off-the-shelf vaccine candidate, mRNA-4359, which targets shared tumour proteins (IDO1 and PD-L1) for immediate use in metastatic solid tumours.
Assuming full data presentation at the upcoming European Society for Medical Oncology (ESMO) 2026 congress and prompt regulatory submissions, analysts estimate a commercial launch could occur by mid-2027.
