Nelipepimut-S
Oncology / ImmunotherapyAlso known as: E75, NeuVax, HER2/neu Peptide Vaccine
Cancer Peptide VaccinesResearch phase: Phase 3 (failed primary endpoint)Regulatory: Not approved. Phase 3 PRESENT trial failed primary endpoint.
Mechanism
Nelipepimut-S (NeuVax) is a HER2-targeted peptide vaccine designed to prevent breast cancer recurrence by training the immune system to attack HER2-expressing cancer cells. Phase 3 results were disappointing.
Technical detail
Nelipepimut-S (E75, NeuVax) is a 9-amino acid peptide (KIFGSLAFL, HER2/neu 369-377) presented by HLA-A2/A3 molecules that stimulates CD8+ cytotoxic T lymphocyte responses against HER2-expressing tumor cells. Administered with GM-CSF adjuvant. Phase 3 PRESENT trial in low-to-intermediate HER2 breast cancer did not meet its primary endpoint of disease-free survival, though subgroup analyses suggested benefit in specific populations.