Hengrui Pharmaceutical issued a notice on October 23, saying: Recently, patients with recurrent or metastatic non-small cell lung cancer (NSCLC) with PD-L1 positive tumor cells (tumor proportion score (TPS) ≥1%) and without EGFR/ALK gene abnormalities treated by carrelizumab combined with legal mitinib, an innovative drug of Hengri Pharmaceutical, were included in the list of breakthrough therapeutic varieties published by the Center for Drug Review of the National Medical Products Administration.
According to the GLOBOCAN 2020 report, the incidence of lung cancer is the second among all malignant tumors, but the mortality rate is the first, which seriously threatens people's health [1]. NSCLC accounts for about 85% of all histopathological types of lung cancer [2]. Due to the lack of early obvious symptoms, most NSCLC is diagnosed as advanced metastatic lung cancer, and the overall prognosis is poor. In the past 10 years, the treatment of advanced NSCLC has gradually changed from chemotherapy to individualized treatment based on driver gene mutation. Those with driver gene mutation can benefit significantly from targeted therapy than chemotherapy. Moreover, targeting immune checkpoint inhibitors such as PD-1/PD-L1 has also made remarkable progress in the treatment of driver gene-negative patients, prolonging the survival of advanced NSCLC. However, at present, the clinical benefit of first-line monotherapy for locally advanced or metastatic NSCLC with PD-L1 TPS≥1% EGFR mutation negative and ALK negative 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 benefiting from immunotherapy, and realize the vision of chemotherapy-free for driver gene-negative NSCLC is an important unmet clinical need.
Carrelizumab for injection is a humanized PD-1 monoclonal antibody independently developed by Hengrui Pharmaceutical and with intellectual property rights. It can bind to human PD-1 receptor and block PD-1/PD-L1 pathway to restore the body's anti-tumor immunity, thus forming the basis of cancer immunotherapy. Since its launch in May 2019, it has been approved for 8 indications in lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer and lymphoma, among which 2 are first-line treatments for NSCLC. It is one of the domestic PD-1 products with the leading number of approved indications and tumor types. Famitinib malate capsule is a small molecule multi-target tyrosine kinase inhibitor independently developed by Henrui, which has inhibitory activity on a variety of receptor tyrosine kinases and belongs to the multi-target anti-angiogenesis targeted drug.
At present, Herui Pharmaceutical is conducting a randomized, open, controlled, multicenter phase III clinical trial of carrelizumab combined with famitinib malate versus pembrolizumab as first-line treatment for recurrent or metastatic non-small cell lung cancer with positive PD-L1 expression.
