GROUNDING — Moderna IR Insights page (source Egor supplied)
- Source: https://www.modernatx.com/ir-insights-phase-3-intesmeran
- Accessed: 2026-08-21
- Exact query: WebFetch of the URL, prompt asking for verbatim statements on intismeran autogene / mRNA-4157, Merck partnership, indication, mechanism, INTerpath-001, NCT, n, RFS/DMFS, interim analysis, hazard ratios, first-positive-Phase-3 claim, manufacturing and regulatory designations.
Verbatim passages
“intismeran autogene, our investigational individualized neoantigen therapy, in combination with pembrolizumab as adjuvant treatment in patients with completely resected Stage IIB-IV melanoma”
“Along with our partners at Merck, we announced positive results”
“Phase 3 INTerpath-001 study”
“This marks the first and only combination regimen to demonstrate a clinically meaningful improvement over pembrolizumab alone”
“take the unique genetic fingerprint of a patient’s tumor and use mRNA to create a medicine designed specifically for that individual patient’s cancer”
“studying intismeran in combination with pembrolizumab and other anti-cancer therapies, and as a monotherapy, across multiple tumor types and stages of disease, including melanoma, lung, bladder and kidney cancers”
“follow patients in INTerpath-001 to evaluate other key secondary endpoints including overall survival”
Evidential weight
- STATES: intismeran autogene is an individualized neoantigen therapy; indication is completely resected Stage IIB-IV melanoma; given in combination with pembrolizumab as adjuvant treatment; Merck is the partner; the Phase 3 is INTerpath-001; the mechanism is per-patient tumour-sequence-derived mRNA.
- DOES NOT STATE on this page: NCT number, n=1137, RFS/DMFS endpoint results, interim analysis, hazard ratios/CIs, “first positive Phase 3 for any individualized neoantigen therapy / any mRNA cancer therapy”, manufacturing turnaround, regulatory designations. Those must be grounded elsewhere — see the other GROUNDING files. Absence here is recorded so no claim leans on this page for them.
- The page’s own superlative is narrower than the brief’s: it claims “first and only combination regimen to demonstrate a clinically meaningful improvement over pembrolizumab alone”, which is a VARIANT of “first positive Phase 3 for any mRNA cancer therapy”, not the same claim.
- Note: this page does not use the code “mRNA-4157” in the extracted text. The mRNA-4157 = intismeran autogene identity requires separate grounding.