Sales of Moderna and Merck’s personalized cancer vaccine intismeran autogene are projected to surpass $1 billion by 2031, following positive Phase III INTerpath-001 results in high-risk resected melanoma, reveals GlobalData, a leading intelligence and productivity platform .

Intismeran autogene, given alongside Merck’s Keytruda (pembrolizumab), met its primary endpoint of statistically significant recurrence-free survival and its key secondary endpoint of distant-metastasis-free survival. Earlier this year, five-year follow-up Phase II data had shown a 49% reduction in the risk of recurrence or death for the combination versus pembrolizumab alone.

The vaccine is fully personalized: tissue from a patient’s resected tumor is sequenced to identify up to 34 mutations unique to their cancer, and Moderna manufactures a custom mRNA sequence encoding them, administered via intramuscular injection to prime the patient’s T cells against those mutations while Keytruda prevents surviving tumor cells from disabling that response.

GlobalData’s latest report, “Melanoma: Epidemiology Forecast to 2035,” shows 112,431 adults in the US were diagnosed with melanoma in 2025, nearly a third of whom fall into the stage II-IV high-risk population intismeran autogene targets.

High-prescribers interviewed by GlobalData report that roughly 20% of stage II and 70% of stage III patients already receive adjuvant therapy.

Intismeran autogene is now in three simultaneous Phase III non-small cell lung cancer (NSCLC) trials: INTerpath-002, combined with pembrolizumab in adjuvant NSCLC following standard chemotherapy; INTerpath-009, for adjuvant NSCLC patients who did not achieve a pathological complete response after neoadjuvant pembrolizumab and chemotherapy; and INTerpath-014, as adjuvant treatment co-formulated with subcutaneous pembrolizumab in high-risk stage I disease.

Additional Phase I/II studies are ongoing in metastatic melanoma, squamous NSCLC, bladder, kidney, gastric, and other solid tumors.

Israel Stern, Healthcare Senior Analyst at GlobalData, comments. “While melanoma is thus far the proof of concept, it is lung cancer that appears to be where Moderna is placing its largest bet.”

Moderna’s second cancer vaccine, mRNA-4359, is in Phase I/II development across melanoma, NSCLC, colorectal, head-and-neck, bladder, and triple-negative breast cancer. Unlike intismeran, it is an off-the-shelf product encoding IDO1 and PD-L1, two tumor proteins that suppress T-cell activity; because these targets are shared across patients, the vaccine can be given immediately, making it a better fit for metastatic disease.

Stern continues: “This creates the potential for sequencing intismeran and mRNA-4359 in the event of relapse. However, if a perioperative vaccine meaningfully reduces recurrence, fewer early-stage patients would eventually progress to the metastatic population. Running intismeran in the perioperative setting and mRNA-4359 in the metastatic setting at the same time allows Moderna to capture patients on both ends.”

Moderna is not alone in the space. Scancell’s iSCIB1+ and Evaxion’s EVX-01 are both in Phase II studies for metastatic melanoma, combined with Opdivo (nivolumab) plus Yervoy (ipilimumab) and with pembrolizumab respectively, while BioNTech and Genentech’s autogene cevumeran, the most direct rival to intismeran’s individualized-neoantigen mechanism, has multiple Phase II trials underway, most advanced in adjuvant pancreatic cancer alongside Roche’s Tecentriq (atezolizumab), followed by chemotherapy.

Assuming a full data presentation at the upcoming European Society of Medical Oncology (ESMO) 2026 congress and a regulatory filing soon after, a realistic US launch could come in mid-2027.

Stern concludes: “The industry is taking notice, and the coming years will likely see sponsors invest heavily in this modality and new vaccines enter the clinic across the cancer spectrum.”