Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its tyrosine kinase inhibitor (TKI) pyrotinib, combined with trastuzumab and docetaxel, met endpoints in a Phase III clinical trial as a first-line treatment for HER2-positive recurrent/metastatic breast cancer. The company plans to hold pre-market approval filing discussions with regulators soon.
Study Details
The randomized, double-blind, parallel-controlled, multi-center Phase III study (HR-BLTN-III-MBC-Cb) involved 590 patients. The primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS), overall response rate (ORR), and safety. Results showed the combination significantly prolonged PFS in patients previously untreated with systemic anti-tumor therapy.
Drug Profile
Pyrotinib is an in-house developed EGFR/HER2 inhibitor. Competing small molecule EGFR/HER2 inhibitors include Tykerb (lapatinib), Nerlynx (neratinib), and Tukysa (tucatinib), which generated combined global sales of USD 687 million in 2021.-Fineline Info & Tech
