Recently, Hengrui Medicine’s ADC innovative drug SHR-A1811 for the treatment of HER2-mutated advanced non-small cell lung cancer who failed previous platinum-based chemotherapy was proposed to be included in the public list of breakthrough therapy varieties by the Center for Drug Evaluation of the National Medical Products Administration.

The study was led by Professor Lu Shun from the Chest Hospital Affiliated to Shanghai Jiaotong University, and a total of 10 centers across the country participated. At the same time, the other two indications of SHR-A1811 have been included in the list of breakthrough therapy varieties by the Drug Evaluation Center of the State Drug Administration in February this year. The indications are: low expression of human epidermal growth factor receptor 2 (HER2). Recurrent or metastatic breast cancer and human epidermal growth factor receptor 2 (HER2) positive recurrent or metastatic breast cancer.

Lung cancer is currently the leading cause of cancer-related death worldwide, and its morbidity and mortality are on the rise year after year. According to GLOBOCAN2020 data, the incidence of lung cancer ranks second among malignant tumors, and the mortality rate ranks first among malignant tumors. The number of new lung cancer cases worldwide is about 2.207 million each year, and the number of deaths is about 1.796 million, ranking first among the causes of cancer deaths.

Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancer subjects, and the incidence of HER2-mutated lung cancer accounts for about 2% of non-small cell lung cancer (the incidence in China is 2.4%-5.94%). This subtype is more common in lung adenocarcinoma and female non-smoking patients. Most of the mutations are exon 20 insertion mutations. It rarely coexists with other driver gene mutations such as EGFR, KRAS, BRAF, and ALK.

For patients with HER2-mutant advanced NSCLC who failed platinum-based chemotherapy, tyrosine kinase inhibitor (TKI, Tyrosine-kinase inhibitor) drugs, HER2 monoclonal antibody and immune checkpoint inhibitor monotherapy (not used in the first line) have limited benefit. The actual efficacy and safety need to be confirmed by more data. In recent years, HER2 antibody-drug conjugate (HER2-ADC) has made great progress in the treatment of NSCLC with abnormal HER2 pathway, and this type of drug is a hot spot in the research and development of this field.

SHR-A1811 for injection is an antibody-drug conjugate independently developed by Hengrui Medicine that targets HER2 and is intended for the treatment of advanced solid tumors with HER2 expression or mutation. SHR-A1811 can specifically bind to HER2 on the surface of tumor cells, and then the conjugate is endocytosed into the cells and transported into lysosomes, and the drug-loaded drug can produce drug effects in tumor cells and induce apoptosis of tumor cells. Death. SHR-A1811 has been approved to carry out a number of Phase I, II, and III clinical studies, aiming to provide a potential treatment option for tumor patients with abnormal HER2 genes, and to provide more clinical evidence for follow-up research and drug benefits to patients.

Over the years, Hengrui Medicine has paid close attention to the treatment status of HER2 expression or mutation tumors in China, and has continued to explore more effective treatment options. In addition to SHR-A1811, the company currently has a number of innovative drug products deployed in various solid tumor treatment fields, with a view to bringing more treatment options to patients.

What is Breakthrough Therapy Designation?

In order to encourage the research and creation of drugs with obvious clinical advantages, the Center for Drug Evaluation (CDE) of the State Drug Administration issued three documents including the "Working Procedures for the Review of Breakthrough Therapy Drugs (Trial)" issued by the State Drug Administration. "Announcement of the People's Republic of China" (No. 82 of 2020), which clarifies the scope of inclusion of breakthrough therapy: during the clinical trial of drugs, it is used to prevent and treat diseases that are seriously life-threatening or seriously affect the quality of life, and there is no effective prevention and treatment method or it is compatible with existing treatment methods. Compared with innovative drugs or improved new drugs with sufficient evidence to show that they have obvious clinical advantages. The Center for Drug Evaluation communicates and exchanges priority allocation resources for drugs included in the breakthrough therapy drug program, strengthens guidance and promotes drug research and development.

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