Intismeran autogene
Merck & Co., Inc. MRK · Carcinoma, Non-Small-Cell Lung; Melanoma; Non-small Cell Lung Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
3
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- Merck & Co., Inc. MRK Source: Company record for Merck & Co., Inc. (opens in a new tab)
- Indications
- Carcinoma, Non-Small-Cell Lung; Melanoma; Non-small Cell Lung Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 19 Jul 20233 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Intismeran autogene. Editors add each one with its source.
Filed application
No filed application is on record for Intismeran autogene. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Intismeran autogene.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06623422ClinicalTrials.gov record for NCT06623422 (opens in a new tab) | A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) | Phase 3 | Recruiting | 680 (estimated) | 16 May 2033 (estimated) | No |
| NCT06077760ClinicalTrials.gov record for NCT06077760 (opens in a new tab)INTerpath-002 | A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002) | Phase 3 | Active, not recruiting | 868 (estimated) | 25 Jun 2030 (estimated) | No |
| NCT05933577ClinicalTrials.gov record for NCT05933577 (opens in a new tab) | A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) | Phase 3 | Active, not recruiting | 1,089 (estimated) | 26 Oct 2029 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Intismeran autogene.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT06623422 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06077760 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05933577 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.