tifcemalimab + toripalimab + chemotherapy

This combination regimen is a neoadjuvant therapy for stage II-III triple-negative breast cancer (TNBC). It integrates tifcemalimab (JS004), a first-in-class humanized IgG4 monoclonal antibody targeting B- and T-lymphocyte attenuator (BTLA), with toripalimab, a humanized IgG4κ monoclonal antibody targeting programmed cell death-1 (PD-1), and a standard chemotherapy backbone. Tifcemalimab functions by blocking the interaction between BTLA and its ligand, herpesvirus entry mediator (HVEM), thereby preventing the inhibition of T-cell activation. Toripalimab blocks the PD-1/PD-L1 pathway to further enhance the immune response. The chemotherapy component typically includes carboplatin, paclitaxel, and an anthracycline (doxorubicin or epirubicin) plus cyclophosphamide. This triple-combination approach is being investigated in a Phase 2 trial (ChiCTR2500108554) led by Shengjing Hospital to evaluate its efficacy in achieving pathological complete response (pCR) compared to toripalimab plus chemotherapy or chemotherapy alone.

Other names

JS004 + toripalimab + chemotherapy-Shengjing Hospital-triple-negative breast cancertifcemalimab + toripalimab + chemotherapy