Recently, Shenzhen Eglin Pharmaceutical Co., Ltd. of China announced that its innovative drug candidate EG-007 has been approved by the U.S. Food and Drug Administration (FDA) to carry out combined use of targeted drugs and anti-PD-1 antibody drugs to treat advanced intrauterine Phase III pivotal clinical trial of membrane cancer. The main goal of this clinical trial is to increase the response rate/effectiveness of immunotherapy in patients with advanced endometrial cancer by combining with EG-007. The results of this phase III clinical trial will be used as a key trial to provide sufficient evidence for EG-007 to obtain the approval of the Global Regulatory Marketing Application (NDA).

The FDA agrees that EG-007 is aimed at patients with advanced endometrial cancer with non-microsatellite high instability (MSI-H) or mismatch repair defect (dMMR), who have progressed after previous systemic treatment and are not suitable for curative surgery or In the case of radiotherapy, phase III clinical trials are carried out. The main efficacy outcome indicators are progression-free survival (PFS), overall survival (OS) assessment, objective response rate (ORR), and duration of response (DOR). This phase III clinical trial aims to prove the superiority of EG-007 in combination with targeted drugs and anti-PD-1 antibody drugs.

Dr. Li Changqing, Chief Medical Officer of China Eglin Medical, said: “This is a key global multi-center phase III clinical trial. The US FDA has twice discussed this phase III clinical trial program with us twice. Endometrial cancer is A common tumor disease in women, the number of new cases in China and the United States in 2020 is 80,000 and 60,000 respectively, and it is also the first high-incidence tumor of the female reproductive system in the United States. Currently, anti-PD-1 antibody drugs are used to treat this The main drug for the disease, because the response rate (effectiveness) of immunotherapy in patients with advanced endometrial cancer is not high, it is ineffective for a considerable number of patients. The use of EG-007 will greatly increase the response rate of patients with advanced endometrial cancer. Response rate/effectiveness of tumor immunotherapy. Due to the huge unmet clinical needs, the US FDA approved EG-007 to directly enter the phase III clinical trial, so that the drug can benefit more patients as soon as possible. EG-007 from Eglin Medicine Development is a global leader in the treatment of advanced endometrial cancer. Our goal is to develop EG-007 combined immunotherapy as a first-line therapy for advanced endometrial cancer."

Dr. Du Xin, Chief Operating Officer of Eglin Pharmaceuticals, said: "The FDA's approval of the Phase III clinical trial of EG-007 is a high recognition of our EG-007 project. Shenzhen Eglin Pharmaceutical Co., Ltd. will promote the development of Phase III clinical trials as soon as possible. Strive to push EG-007 into the market as soon as possible and bring new hope to patients with advanced endometrial cancer."