Hengrui PD-1 monoclonal antibody combined with Famitinib for the treatment of non-small cell lung cancer phase III clinical approval

October 27, 2021

On October 26, Hengrui Pharmaceuticals announced that it had obtained the "Notice of Drug Clinical Trial Approval" approved and issued by the National Medical Products Administration, approving the company to develop carrelizumab combined with famitinib malate versus pembrolizumab A randomized, open, controlled, multi-center phase III clinical study for the first-line treatment of recurrent or metastatic non-small cell lung cancer with positive PD-L1 expression.

According to the 2020 statistics report, the incidence of lung cancer is the second of all malignant tumors, but the mortality rate is the first, of which 85% is non-small cell lung cancer (NSCLC). In the past 10 years, the treatment of advanced NSCLC has gradually changed from chemotherapy-based treatment to individualized treatment based on whether the driving gene mutation or not. Those with driver gene mutations can benefit from targeted therapy significantly better than chemotherapy; and for those with negative driver gene mutations, treatments targeting immune checkpoints such as PD-1/PD-L1 have also achieved remarkable results. Progress has greatly extended the survival period of advanced NSCLC. Although PD-(L)1 checkpoint inhibitors have completely changed the treatment model of NSCLC and brought lasting benefits to patients with specific subtypes of advanced NSCLC. However, for newly-treated patients with positive PD-L1 expression (TPS≥1%), the benefits of anti-PD-(L)1 monotherapy or in combination with anti-CTLA-4 antibodies are still relatively limited. Therefore, current immunotherapy is effective On the basis of this, how to further improve the efficacy of immunotherapy, expand the population benefiting from immunotherapy, and achieve chemotherapy-free driving gene-negative NSCLC, there are important unmet clinical needs. Anti-angiogenic drugs combined with anti-PD-1/PD-L1 antibodies can produce synergistic effects. Currently, a number of international phase III clinical studies of anti-angiogenic drugs combined with anti-PD-1/PD-L1 antibodies for the first-line treatment of NSCLC are ongoing. Carrelizumab for injection is a humanized anti-PD-1 monoclonal antibody that can bind to human PD-1 receptors and block the PD-1/PD-L1 pathway, restore the body’s anti-tumor immunity, thereby Form the basis of cancer immunotherapy. The first class of new therapeutic biological products developed for Hengrui Pharmaceuticals was approved by the NMPA in May 2019. Since its launch in China in 2019, 6 indications have been approved, including Hodgkin's lymphoma, liver cancer, lung cancer, esophageal cancer, second-line and above nasopharyngeal carcinoma, and first-line nasopharyngeal carcinoma, which is currently the most approved indication. Domestically produced PD-1 products. Famitinib Malate Capsule is a small molecule multi-target tyrosine kinase inhibitor developed by the company, which is a multi-target anti-angiogenesis targeted drug. It is currently undergoing clinical development in China and the United States. The results of pre-clinical studies suggest that carrelizumab combined with famitinib has a synergistic effect. Based on the preliminary data of an open, multi-cohort, multi-center phase II clinical study of carrelizumab combined with famitinib malate in the treatment of advanced solid tumors, the combination of carrelizumab and famitinib malate is based on preliminary data Nitraria is expected to further improve the efficacy of first-line treatment of relapsed or metastatic NSCLC with positive PD-L1 expression.

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