Will a regulator accept a registration filing for intismeran autogene combined with pembrolizumab in resected melanoma before 31 December 2027?
deadline 2027-12-31
confidence high
tier 2 evidence
Resolution being verified
SEC : 1 dépôt(s) 8-K contenant "intismeran" — le plus récent du 2026-09-30 (Moderna, Inc. (MRNA) (CIK 0001682852)) ·
source
85%PolySignal estimate
Resolution criterion
Yes if Merck or Moderna publicly announces the FDA's acceptance of a BLA or the EMA's validation of an MAA for this combination in melanoma, by 31 December 2027. A submission not confirmed as accepted counts as no.
Verified starting state
The phase 3 INTerpath-001 trial met its primary recurrence-free survival endpoint and the key secondary endpoint of distant metastasis-free survival in patients with completely resected stage IIB-IV melanoma. This is the first positive phase 3 readout for an individualised neoantigen therapy. No filing timeline has been communicated. (19 August 2026)
What pushes it up
- The Phase 3 INTerpath-001 trial met its primary and key secondary endpoints, providing strong clinical evidence for filing [0, 3].
- The therapy has previously received Breakthrough Therapy and PRIME designations, which typically expedite regulatory interactions and filing processes.
- Merck and Moderna are actively preparing for market debut, indicating high motivation to file quickly [1].
What pushes it down
- As a novel individualized mRNA therapy, the manufacturing and CMC (Chemistry, Manufacturing, and Controls) requirements are highly complex, which could delay the filing preparation.
- No official filing timeline has been communicated by the sponsors as of August 2026 [Starting state].
What would move this number most
Whether manufacturing and CMC data preparation for this novel personalized therapy encounters unexpected regulatory hurdles or delays.
How this number is built
| Deadline | 2027-12-31 |
| Base rate | 80% |
| Best evidence | tier 2 · 3 article(s) used |
| Independent runs | 85 · 85 (spread 0 pts) |
| Confidence | high |
| Evidence cap | not triggered |
| Last revised | 2026-09-20 09:06 |
| Model | gemini-3.5-flash |
Sources consulted