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mRNA-4157 (intismeran autogene; V940) is an investigational mRNA-based individualized neoantigen therapy (INT) jointly developed by Merck and Moderna. It is designed for each patient based on the unique set of mutations within their tumor to train and activate the immune system to recognize and fight cancer. In the Phase 3 INTerpath-001 trial in patients with completely resected stage IIB-IV melanoma, intismeran in combination with pembrolizumab (KEYTRUDA) met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS).
mRNA-4157 (intismeran autogene; V940) is an investigational mRNA-based individualized neoantigen therapy (INT) jointly developed by Merck and Moderna. It is designed for each patient based on the unique set of mutations within their tumor to train and activate the immune system to recognize and fight cancer. In the Phase 3 INTerpath-001 trial in patients with completely resected stage IIB-IV melanoma, intismeran in combination with pembrolizumab (KEYTRUDA) met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS).
Each therapy consists of a synthetic mRNA coding for up to 34 neoantigens and is tailored to the unique biology of an individual patient's tumor. Upon administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, a key step in generating specific T-cell responses against cancer cells.
Adjuvant treatment of patients with completely resected stage IIB-IV melanoma (investigated in combination with pembrolizumab; Phase 3 INTerpath-001 met RFS and DMFS endpoints, not yet approved).