MRNA · 10-Q · 2026Q3 · Full report

Product / Drug Pipeline Progress

Moderna, Inc. · 2026-11-06 · Importance 53 · Surprise 60 · In source text

Moderna and Merck reported positive Phase 3 INTerpath-001 results for intismeran autogene (mRNA-4157) plus KEYTRUDA in patients with completely resected stage IIB–IV melanoma. After median follow-up of 24.6 months, the combination reduced the risk of recurrence or death by 42% and distant metastasis or death by 38% versus KEYTRUDA alone; overall survival data remain immature. The INTerpath program comprises nine Phase 2 and Phase 3 trials across multiple tumor types and disease stages, including three Phase 3 trials in non-small cell lung cancer. Moderna also initiated a Phase 1 trial of its investigational bundibugyo ebolavirus vaccine, mRNA-1469, in Canada and reported a recommendation to advance it to a Phase 2/3 efficacy study in the Democratic Republic of Congo.

Key facts

• At a median follow-up of 24.6 months, intismeran plus KEYTRUDA reduced recurrence or death risk by 42% and distant metastasis or death risk by 38% compared with KEYTRUDA alone. source
• In November 2026, mRNA-1469 was recommended to advance into a Phase 2/3 efficacy study in the Democratic Republic of Congo. source
• In an analysis at six months following the intismeran immunization regimen, adding intismeran to KEYTRUDA reduced recurrence-or-death risk by 58% and distant-metastasis-or-death risk by half versus KEYTRUDA alone. source
• After the Phase 3 interim analysis of its norovirus vaccine did not meet statistical criteria for early success, Moderna did not plan to initiate an additional cohort that season and intended to engage health authorities on the program’s path forward. source
• The separate mFLUSIVA clinical trial for adults 65 and older enrolled 2,992 adults in the United States; clinical benefit in this population will be further assessed in a postmarketing confirmatory trial. source
• In August 2026, Moderna and Merck announced positive topline Phase 3 INTerpath-001 results; the trial met its primary recurrence-free survival endpoint and a key secondary distant metastasis-free survival endpoint. source
• In August 2026, FDA approved the 2026–2027 formulas for Spikevax and mNEXSPIKE containing the JN.1-lineage XFG subvariant of SARS-CoV-2. source
• In August 2026, Moderna initiated a Phase 1 clinical trial of investigational bundibugyo ebolavirus vaccine mRNA-1469 in Canada as part of its expanded CEPI collaboration. source

Impact estimates