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This is an investigational combination therapy consisting of pembrolizumab, a programmed cell death protein 1 (PD-1) immune checkpoint inhibitor monoclonal antibody, and an α-lactalbumin-based cancer vaccine. The α-lactalbumin vaccine targets the milk protein α-lactalbumin, which is expressed in lactating breast tissue and in approximately 70% of triple-negative breast cancers (TNBC), but not in other normal tissues. The rationale for this combination is to stimulate antigen-specific T-cell responses against TNBC cells expressing α-lactalbumin while simultaneously blocking PD-1-mediated immunosuppression with pembrolizumab. Early-phase clinical trials have demonstrated that the combination elicits robust T-cell immune responses with a favorable safety profile—primarily limited to injection site reactions—and no major systemic adverse events reported when used together. This approach aims to reduce recurrence risk or potentially prevent TNBC development in high-risk populations[1][3][6].
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