Intismeran autogene is an investigational individualized neoantigen mRNA therapy developed as V940 (mRNA-4157), currently studied in combination with pembrolizumab. It has shown recurrence-free survival benefit in a Phase 2b study in resected high-risk melanoma and is being evaluated in multiple Phase 2/3 trials across tumor types. The therapy is not described as approved and remains in clinical development.
Moderna and Merck advance a Phase 2 trial of mRNA cancer vaccine V940 with pembrolizumab and chemotherapy for metastatic squamous NSCLC. In biliary tract cancer, first-line treatment combines chemotherapy with immunotherapy, while targeted therapy resistance prompts liquid biopsy. ImmunityBio tests a chemotherapy-free NK-cell regimen in non-Hodgkin lymphoma.
Moderna partners with Recordati on propionic acidemia therapy for up to $160 million, while FDA Commissioner defends mRNA vaccine support following funding cuts and regulatory challenges.
Moderna and Merck are recruiting patients for a Phase 2 trial testing V940, an mRNA-based cancer vaccine, combined with Keytruda and chemotherapy as first-line treatment for metastatic squamous non-small cell lung cancer.
Moderna and Merck have begun recruiting for a Phase 2 trial testing V940, an mRNA-based personalized cancer vaccine, combined with Keytruda and chemotherapy as first-line treatment for metastatic squamous non-small cell lung cancer.
Merck stock reached a 52-week high at $122.69, rising 46.25% over 12 months and 7.4% in the past month following strong Q4 results and improved long-term pipeline outlook beyond Keytruda's 2028 patent expiration.
Moderna and Merck announced median five-year follow-up data showing intismeran autogene in combination with Keytruda reduced the risk of melanoma recurrence or death by 49% in high-risk patients following complete resection.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07221474 |
A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013) |
RECRUITING | PHASE2 |
| NCT06961006 |
A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012) |
RECRUITING | PHASE2 |
| NCT06833073 |
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) |
RECRUITING | PHASE2 |
| NCT06623422 |
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) |
RECRUITING | PHASE3 |
| NCT06307431 |
A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004). |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06305767 |
A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005) |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT06295809 |
A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) |
TERMINATED | PHASE2/PHASE3 |
| NCT06077760 |
A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002) |
RECRUITING | PHASE3 |
| NCT05933577 |
A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) |
ACTIVE_NOT_RECRUITING | PHASE3 |
