Drug intelligence / Profile preview

pembrolizumab + berahyaluronidase alfa + sacituzumab tirumotecan

Development stage
Unknown
Lead developer
Kelun-Biotech
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Administration
Intravenous, Subcutaneous
01

Overview

Keytruda Qlex + sacituzumab tirumotecan is an investigational combination regimen consisting of Keytruda Qlex (a subcutaneous formulation of the anti-PD-1 monoclonal antibody pembrolizumab co-formulated with berahyaluronidase alfa) and sacituzumab tirumotecan (sac-TMT, MK-2870, SKB264), a TROP2-directed antibody-drug conjugate (ADC) carrying a topoisomerase I inhibitor payload. Pembrolizumab acts as an immune checkpoint inhibitor by blocking the interaction between PD-1 and its ligands (PD-L1 and PD-L2), thereby restoring T-cell-mediated anti-tumor immune responses. Berahyaluronidase alfa is a recombinant human hyaluronidase that temporarily depolymerizes hyaluronan in the subcutaneous tissue, facilitating the dispersion and absorption of pembrolizumab to enable rapid subcutaneous administration. Sacituzumab tirumotecan targets TROP2, a cell-surface glycoprotein highly expressed in various epithelial tumors, and delivers a belotecan-derived topoisomerase I inhibitor payload (KL610023) directly to cancer cells, inducing DNA damage and apoptosis. The combination is being evaluated in Phase 3 clinical trials (such as TroFuse-055) for the treatment of muscle-invasive bladder cancer (MIBC) and other solid tumors.

Other names
Keyject + sacituzumab tirumotecanKeytruda Qlex + sacituzumab tirumotecanKeytruda SC + sacituzumab tirumotecanMK-3475A + MK-2870MK-3475A + SKB264pembrolizumab + berahyaluronidase alfa + sacituzumab tirumotecanpembrolizumab and berahyaluronidase alfa + sacituzumab tirumotecanpembrolizumab and berahyaluronidase alfa-pmph + sacituzumab tirumotecanpembrolizumab/berahyaluronidase alfa + sacituzumab tirumotecanpembrolizumab SC + sacituzumab tirumotecansubcutaneous pembrolizumab + sacituzumab tirumotecan
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)TACSTD2 (Tumor-associated calcium signal transducer 2)

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