VIR-5818 + pembrolizumab

VIR-5818 + Keytruda (pembrolizumab) is an investigational combination regimen being evaluated for the treatment of locally advanced or metastatic HER2-expressing solid tumors, including HER2-positive colorectal and breast cancers. VIR-5818 (formerly AMX-818 or SAR446309) is a dual-masked, protease-activated T-cell engager (TCE) developed using the PRO-XTEN platform. It is designed to target HER2-expressing tumor cells and CD3 on T cells, with its masks remaining intact in systemic circulation to minimize off-tumor toxicity and being selectively cleaved by proteases in the tumor microenvironment. Keytruda (pembrolizumab) is an approved humanized IgG4 monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor, which blocks the interaction with its ligands PD-L1 and PD-L2 to enhance T-cell-mediated anti-tumor immune responses. The combination is being evaluated in a Phase 1 clinical trial (NCT05356741) to assess safety, tolerability, and preliminary efficacy.

Other names

AMX-818 + KeytrudaAMX-818 + MK-3475AMX-818 + pembrolizumabSAR446309 + KeytrudaSAR446309 + MK-3475SAR446309 + pembrolizumabVIR-5818 + KeytrudaVIR-5818 + MK-3475