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
84%Asturna 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 INTerpath-001 trial met both its primary recurrence-free survival and key secondary distant metastasis-free survival endpoints, providing a strong clinical package for submission [tier 1, tier 2, article 0].
- With more than 14 months remaining until 31 December 2027, standard regulatory preparation and the 60-day FDA acceptance window comfortably fit within the deadline [general knowledge].
- High unmet medical need and expedited regulatory designations previously granted to this combination create strong incentives for Merck and Moderna to prioritize swift filing [general knowledge].
What pushes it down
- No official filing timeline has been formally communicated by Merck or Moderna [tier 1].
- As an individualized neoantigen mRNA therapy, complex chemistry, manufacturing, and controls (CMC) validation could lengthen dossier preparation beyond typical timelines [general knowledge].
What would move this number most
Whether manufacturing and CMC dossier readiness for an individualized therapy causes delays beyond mid-2027.
How this number is built
| Deadline | 2027-12-31 |
| Base rate | 80% |
| Best evidence | tier 2 · 1 article(s) used |
| Independent runs | 82 · 85 (spread 3 pts) |
| Confidence | high |
| Evidence cap | not triggered |
| Last revised | 2026-10-11 09:12 |
| Model | gemini-3.7-flash |
Sources consulted
Probability history
2026-10-11 09:12 84% 10 article(s) on file · gemini-3.7-flash
- What pushes it up. The INTerpath-001 trial met both its primary recurrence-free survival and key secondary distant metastasis-free survival endpoints, providing a strong clinical package for submission [tier 1, tier 2, article 0].
- What pushes it up. With more than 14 months remaining until 31 December 2027, standard regulatory preparation and the 60-day FDA acceptance window comfortably fit within the deadline [general knowledge].
- What pushes it up. High unmet medical need and expedited regulatory designations previously granted to this combination create strong incentives for Merck and Moderna to prioritize swift filing [general knowledge].
- What pushes it down. No official filing timeline has been formally communicated by Merck or Moderna [tier 1].
- What pushes it down. As an individualized neoantigen mRNA therapy, complex chemistry, manufacturing, and controls (CMC) validation could lengthen dossier preparation beyond typical timelines [general knowledge].
- What would move this number most. Whether manufacturing and CMC dossier readiness for an individualized therapy causes delays beyond mid-2027.
2026-09-20 09:06 85% 4 article(s) on file · gemini-3.5-flash
Reasons not recorded for this revision (detailed history has only been kept since recently).