Evergreen Therapeutics Announces FDA Clearance to Initiate Pivotal Phase 3 Trial of EG-007 in Combination Therapy for Advanced Endometrial Cancer

Recently, Shenzhen Egret Medicine Co., Ltd. announced that its innovative candidate drug EG-007 has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase III clinical trial evaluating its use in combination with targeted therapies and anti-PD-1 antibodies for the treatment of advanced endometrial cancer. The primary objective of this clinical trial is to enhance the response rate/efficacy of immunotherapy in patients with advanced endometrial cancer through combination therapy with EG-007. The results of this Phase III clinical trial will serve as key evidence to support the global regulatory New Drug Application (NDA) for EG-007.

The FDA has approved the initiation of a Phase III clinical trial for EG-007 in patients with advanced endometrial cancer who are not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), have experienced disease progression after prior systemic therapy, and are not candidates for curative surgery or radiation therapy. The primary efficacy endpoints include progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and duration of response (DOR). This Phase III clinical trial aims to demonstrate the superiority of EG-007 in combination with targeted therapies and anti-PD-1 antibodies. Specific details regarding the clinical trial protocol will be posted and updated on ClinicalTrials.gov by the company.

Dr. Li Changqing, Chief Medical Officer of Aegle Pharmastated: “This is a global, multicenter, pivotal Phase III clinical trial. The U.S. FDA has engaged in two in-depth discussions with us regarding the protocol for this Phase III trial. Endometrial cancer is a common malignancy among women, with 80,000 and 60,000 new cases reported in China and the United States, respectively, in 2020. It is also the most prevalent tumor of the female reproductive system in the United States. Currently, anti-PD-1 antibodies are the primary therapeutic agents for this condition; however, due to the low response rate (efficacy) of immunotherapy in patients with advanced endometrial cancer, it proves ineffective for a substantial proportion of patients. The use of EG-007 will significantly enhance the response rate/efficacy of tumor immunotherapy in patients with advanced endometrial cancer. In light of the significant unmet clinical need, the U.S. FDA has agreed to allow EG-007 to proceed directly into Phase III clinical trials, thereby accelerating patient access to this therapy. Aeglea Pharma’s development of EG-007 is at the global forefront in the treatment of advanced endometrial cancer. Our goal is to develop EG-007 in combination with immunotherapy as a first-line treatment for advanced endometrial cancer.”

Dr. Xin Du, Chief Operating Officer of Egrin PharmaceuticalsStatement: “The FDA’s approval of the Phase III clinical trial for EG-007 is a strong endorsement of our EG-007 program. Shenzhen Aigelun Pharmaceutical Co., Ltd. will expedite the initiation of the Phase III clinical trial, striving to bring EG-007 to market as soon as possible and offer new hope to patients with advanced endometrial cancer.”

Shenzhen Aigelin Pharmaceutical Co., Ltd. is an innovative pharmaceutical company founded by several former senior FDA reviewers and more than ten former executives from multinational pharmaceutical companies. It focuses on the research and development of therapeutic drugs addressing urgent clinical needs, with an emphasis on the clinical research, development, and commercialization of innovative drugs. In 2020, the company obtained three investigational new drug (IND) approvals from the U.S. FDA. In March 2021, Aigelin Pharmaceutical coordinated multiple institutional investors to complete its Series A financing round, raising RMB 100 million. Currently, Aigelin Pharmaceutical is simultaneously developing more than 10 candidate drugs, three of which have entered Phase I to Phase II clinical trials. EG-007 is the fourth candidate drug from Aigelin Pharmaceutical to enter clinical development.