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The U.S. Food and Drug Administration (FDA) Has Approved Evergreen's EG-007 for Phase III Pivotal Clinical Trial
Source:Egpharm Date: Aug,2021 Views: 513

On August 10, 2021, Shenzhen Evergreen Pharmaceutical Co., Ltd. announced that its innovative drug candidate EG-007 has been approved by the U.S. Food and Drug Administration (FDA) to conduct a phase III pivotal clinical trial in combination with targeted drugs and anti-PD-1 antibody drugs for the treatment of advanced endometrial cancer. The primary objective of this clinical trial is to improve the therapeutic effect/response rate to immunotherapy in patients with advanced endometrial cancer by combining EG-007. The results of this phase III clinical trial will serve as a pivotal trial to provide sufficient evidence for EG-007 to receive global regulatory marketing filing (NDA) approval.


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FDA approved EG-007 for phase III clinical trials in patients with advanced endometrial cancer with non-microsatellite high instability (MSI-H) or mismatch repair defect (dMMR) whose disease has progressed after previous systemic therapy and is not suitable for curative surgery or radiation therapy. The primary efficacy outcome measures were progression-free survival (PFS), overall survival (OS) assessment, objective response rate (ORR), and duration of response (DOR). The phase III trial aims to demonstrate the efficacy of EG-007 in combination with targeted drugs and anti-PD-1 antibody classes. Specific details of the clinical trial protocol will be posted and updated at ClinicalTrials.gov.

 

Dr. Changqing Li, Chief Medical Officer at Evergreen said, "This is a pivotal, multi-center, global phase III clinical trial. The FDA has discussed this phase III clinical trial protocol with us in depth on two occasions. Endometrial cancer is a common tumor disease in women. In 2020, there were 80,000 new cases in China and 60,000 new cases in the United States, and it is the first most common tumor in the reproductive system of American women. At present, anti-PD-1 antibodies are the main treatment for this disease, and immunotherapy is ineffective in a significant number of patients due to the low response rate (effectiveness) in patients with advanced endometrial cancer. The use of EG-007 will significantly improve the response rate/effectiveness of tumor immunotherapy in patients with advanced endometrial cancer. Due to the huge unmet clinical need, the US FDA agreed to allow EG-007 to go directly into phase III clinical trials in order to make the drug available to more patients as soon as possible." Our EG-007 development is a global leader in the treatment of advanced endometrial cancer, and our goal is to develop EG-007 in combination with immunotherapy as a first-line treatment for advanced endometrial cancer."

 

Dr. Du Xin, Chief Operating Officer of Evergreen said, "FDA's approval of the phase III clinical trial of EG-007 is a high recognition of our eg-007 program. Evergreen will move forward with the phase III clinical trial as soon as possible, and strive to bring EG-007 to the market and bring new hope to patients with advanced endometrial cancer."

 

About Evergreen Therapeutics:

 

Evergreen Therapeutics is an innovative pharmaceutical company founded by a number of former FDA senior reviewer and more than a dozen former executives of multinational pharmaceutical companies. Evergreen focuses on the research and development of therapeutic drugs with urgent clinical needs, and focuses on the clinical research, development and commercialization of innovative drugs. In 2020, Evergreen has received three FDA clinical trial approvals. In March 2021, Evergreen coordinated with a number of institutional investors and completed the a round of financing of RMB 100 million. Evergreen is currently developing more than 10 drug candidates, including three that are in Phase I to Phase IV clinical trials. EG-007 is the fourth drug candidate to enter clinical development.

 

For more information about Evergreen, please visit our website: http://www.egpharm.com/