Hot right now! The combination therapy with camrelizumab of Hengrui Medicine is planned to be included in the breakthrough therapy category

Hengrui Pharma announced on October 23 that: Recently, Hengrui Pharmaceutical's innovative drug carrelizumab combined with mitinib in the first-line treatment of recurrent or metastatic non-small cell lung cancer with positive PD-L1 expression [tumor proportion score (TPS) ≥1%] and without EGFR/ALK gene abnormalities has been included in the public list of breakthrough therapies by the Center for Drug Evaluation of the National Medical Products Administration.

According to GLOBOCAN 2020 report, lung cancer ranks second in incidence of all malignant tumors, but ranks first in mortality, posing a serious threat to people's health [1]. Among all histopathological types of lung cancer, NSCLC accounts for about 85%[2]. Due to the lack of early symptoms, most NSCLC is diagnosed as advanced metastatic lung cancer, and the overall prognosis is poor. In the past decade, the treatment of advanced NSCLC has gradually changed from chemotherapy to individualized treatment based on the presence or absence of driver gene mutations. Patients with driver gene mutations can benefit significantly more from targeted therapy than chemotherapy. For patients with negative driver genes, the treatment of immune checkpoint inhibitors such as PD-1/PD-L1 has also made remarkable progress, which prolongs the survival of advanced NSCLC. However, at present, the clinical benefit of first-line monotherapy for EGFR mutation-negative and ALK-negative locally advanced or metastatic NSCLC with PD-L1 TPS≥1% is still relatively limited [3]. Therefore, on the basis of the effectiveness of current immunotherapy, how to further improve the efficacy of immunotherapy, expand the population who can benefit from immunotherapy, and achieve the vision of chemotherapy-free for NSCLC with negative driver genes is an important unmet clinical need.

Camrelizumab for injection is a humanized PD-1 monoclonal antibody independently developed by Henrui Medicine and with intellectual property rights. It can bind to the human PD-1 receptor and block the PD-1/PD-L1 pathway to restore the body's anti-tumor immunity, thereby forming the basis of cancer immunotherapy. It has been approved for eight indications in lung cancer, liver cancer, esophageal cancer, nasopharyngeal carcinoma and lymphoma, two of which are first-line treatment for NSCLC. It is one of the domestic PD-1 products with the leading indications and tumor types. Famitinib malate capsule is a small molecule multi-target tyrosine kinase inhibitor independently developed by Hengrui. It has inhibitory activity on a variety of receptor tyrosine kinases and belongs to multi-target anti-angiogenesis targeted drugs.

Currently, Hendrong Medicine is carrying out a randomized, open, controlled, multicenter phase Ⅲ clinical trial of camrelizumab combined with famitinib malate versus pembrolizumab as first-line treatment for recurrent or metastatic non-small cell lung cancer with positive PD-L1 expression.

What is breakthrough therapy designation?

For encourages research and development has obvious advantages of clinical drug state drug administration drug approval center (CDE) issued the state food and drug administration about publish < breakthrough drug review program (try out) > three files such as announcement no. 82 (2020), has been clear about the breakthrough treatments included in the scope: During drug clinical trials, innovative drugs or improved new drugs are used to prevent and treat diseases that are seriously life-threatening or seriously affect the quality of life, and there are no effective prevention and treatment methods or sufficient evidence to show that they have obvious clinical advantages compared with existing treatment methods. The centers communicated with each other on the priority allocation of drugs included in the breakthrough therapy program to strengthen guidance and promote drug research and development.