Recently, Hengrui Pharmaceutical received the Drug Registration Certificate approved and issued by the National Drug Administration (NMPA), which approved the company's self-developed human epidermal growth factor 1/2/4 (HER1/HER2/HER4) targeting drug pyrrolitinib (Arini) in combination with trastuzumab and docetaxel for first-line treatment of HER2 positive advanced breast cancer, This is a double target combination of receptor tyrosine kinase inhibitor (TKI) and macromolecular antibody drugs for the treatment of advanced breast cancer, bringing new drug options for patients with advanced breast cancer. This approved indication is the combination of this product with trastuzumab and docetaxel, which is applicable to the treatment of recurrent or metastatic breast cancer patients with positive epidermal growth factor receptor 2 (HER2) and who have not received anti HER2 treatment in the late stage. This indication has been approved for marketing based on a randomized, double-blind, parallel controlled, multicenter Phase III clinical study (PHILA study, study number HR-BLTN-III-MBC-C). The results showed that, for HER2 positive breast cancer patients who did not receive any anti HER2 treatment at the advanced stage, receiving pyrrolitinib maleate tablets combined with trastuzumab and docetaxel had significant progress free survival (PFS) benefits. The main endpoint was the investigator's assessment of PFS, with a median value of 24.3 months. A breakthrough has been made in the benefits of PFS for first-line treatment of HER2 positive advanced breast cancer confirmed by phase III trials. Breakthrough in the treatment of HER2 positive breast cancer with large and small molecules This approval of pyrrolitinib, trastuzumab and docetaxel for first-line treatment of HER2 positive breast cancer in advanced stage is based on the breakthrough results of PHILA research. The research findings were presented orally at the 2022 European Society of Oncology (ESMO) annual meeting. PHILA study is a phase III clinical study to evaluate the first-line treatment of HER2 positive recurrent/metastatic breast cancer with pyrrolitinib in combination with trastuzumab and docetaxel compared with placebo in combination with trastuzumab and docetaxel. Academician Xu Binghe from the Cancer Hospital of the Chinese Academy of Medical Sciences served as the main researcher, and 40 centers across the country participated in the study. A total of 590 subjects were enrolled. The research results showed that the main endpoint of the study was the median PFS test group evaluated by the researchers reaching 24.3 months (control group 10.4 months, HR=0.41); Secondary study endpoint: The median PFS trial group evaluated by the independent review committee reached 33.0 months (control group 10.4 months, HR=0.35), with an ORR of 82.8% and 70.6% for the trial and control groups, and a median DoR of 25.9 months and 9.5 months, respectively. In September 2022, once the PHILA study was published, the PyHT program was included in the first-line treatment of HER2 positive advanced breast cancer in the same year in the Guidelines for Standardized Diagnosis and Treatment of Advanced breast cancer in China (2022 version) (PyHT is the IB level recommended program) and the Guidelines and Specifications for Diagnosis and Treatment of Cancer Society of China (2022 essential version) (PyHT is the "consideration" program)
Edit：Guanguan Responsible editor：Niexiaoqian
Source：XinhuaNet
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