Drug intelligence / Profile preview

intismeran autogene + pembrolizumab

Development stage
Phase 3
Lead developer
Moderna
Modality
Vaccines & Immunotherapeutics, mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intramuscular, Intravenous
01

Overview

V940 + Keytruda is an investigational combination of intismeran autogene (V940; mRNA-4157) and pembrolizumab (Keytruda). Intismeran autogene is an mRNA-based individualized neoantigen therapy (INT) designed to encode up to 34 patient-specific tumor neoantigens based on the unique mutational signature of the patient's tumor. Pembrolizumab is a humanized monoclonal antibody that targets the programmed cell death protein 1 (PD-1) receptor, acting as an immune checkpoint inhibitor. Together, the combination works via a dual mechanism: intismeran autogene actively generates a personalized T-cell immune response against the tumor, while pembrolizumab blocks the PD-1 pathway to prevent immune evasion. The combination is being jointly developed by Moderna and Merck as an adjuvant treatment for various cancers, including melanoma, non-small cell lung cancer, and cutaneous squamous cell carcinoma, and has demonstrated significant improvements in recurrence-free survival and distant metastasis-free survival in Phase 3 trials.

Other names
intismeran + pembrolizumabintismeran autogene + Keytrudaintismeran autogene + pembrolizumabmRNA-4157 + KeytrudamRNA-4157 + pembrolizumabV940 + KeytrudaV940 + pembrolizumab
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)CD274 (Programmed cell death protein 1 ligand 1)PDCD1LG2 (Programmed cell death 1 ligand 2)

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