Drug intelligence / Profile preview

HLX02 + pertuzumab + chemotherapy

Development stage
Unknown
Lead developer
Henlius
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

This combination therapy consists of HLX02 (a trastuzumab biosimilar developed by Henlius), pertuzumab, and chemotherapy (such as taxanes, gemcitabine, capecitabine, or vinorelbine). It is being evaluated in a Phase II clinical trial (NCT05188495) led by Peking University Cancer Hospital & Institute for the treatment of HER2-positive metastatic breast cancer in patients who have previously progressed on trastuzumab-based regimens. The regimen utilizes dual HER2 blockade; HLX02 binds to subdomain IV of the HER2 extracellular domain, while pertuzumab binds to subdomain II, preventing HER2 heterodimerization with other HER receptors, particularly HER3. This synergistic approach, combined with the cytotoxic effects of chemotherapy, aims to overcome resistance to single-agent HER2 inhibition and improve progression-free survival in the second-line or later setting.

Brand names
ZercepacPerjeta
Other names
Henlius trastuzumabtrastuzumab (Henlius)TPC
02

Targets

TS (Thymidylate synthase)TUBB (Tubulin (alpha and beta subunits))RNR (Ribonucleotide reductase)HER2 ECD subdomain II (Human epidermal growth factor receptor 2 dimerization interface)

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