Gilead Sciences' ADC Drug Sacituzumab Govitecan Receives New Clinical Approval in China for Endometrial Cancer

China National Medical Products AdministrationThe official website of the Center for Drug Evaluation (CDE) recently announced that Gilead Sciences has submittedSacituzumab Govitecan for InjectionApproved for another clinical study, with the indication beingUsed for patients who have previously received platinum-based chemotherapy and anti-programmed cell death protein 1/programPatients with recurrent or advanced endometrial cancer experiencing disease progression after sex cell death ligand 1 (anti-PD-1/PD-L1) therapy。

Screenshot source:CDE Official Website

Sacituzumab Govitecan for Injection (sacituzumab govitecan，English Trade Name: Trodelvy) isATargeting Trop-2Antibody-Drug Conjugates (ADC）。TROP2 is highly expressed in many solid tumors and is one of the popular targets for ADC drug development.Sacituzumab govitecan is designed to link the topoisomerase inhibitor SN-38 to a monoclonal antibody through a hydrolysable linker. This combination delivers the active pharmaceutical ingredient to cells and the microenvironment expressing Trop-2.

Currently, sacituzumab govitecan has been approved for multiple indications in the United States,IncludingTriple-Negative Breast Cancer，HR+/HER2- Breast CancerAnd urothelial carcinoma (mUC), etc. At the same time, targetingClinical studies on lung cancer, head and neck cancer, and endometrial cancer are ongoing.

In China，Gilead SciencesTocilizumab EarliestApproved by NMPA in 2022 for the treatment ofLocally Advanced or Metastatic Triple-Negative Breast Cancer.According to the China Drug Clinical Trial Registration and Information Disclosure Platform, there are three clinical studies of Sacituzumab Govitecan currently underway. They include:

• Monotherapy for unresectable locally advanced or metastaticTriple-Negative Breast CancerAdult patients;

• Advanced or unresectableMetastatic Breast Cancer and Stage IV Breast Cancer;

• Pembrolizumab combined with sacituzumab govitecan for high PD-L1 expression (tumor cell positivity proportion score ≥50%) in epidermal growth factor receptor (EGFR) Gene mutation-negative and anaplastic lymphoma kinase (ALK)-negativeFirst-line treatment for metastatic non-small cell lung cancer.

Endometrial cancer is the second most common gynecologic cancer globally, with both incidence and mortality on the rise. While early or localized endometrial cancer can be treated with surgical resection, leading to a favorable prognosis for patients, the five-year survival rate for those with advanced, metastatic, or recurrent endometrial cancer is less than 20%.

This time, the injectable Sacituzumab Govitecan has been approved again.Batch clinical trials mean that this new ADCThe drug is about to be used for the treatment of endometrial cancer in China.

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 23, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2] Official Website of China Drug Clinical Trial Registration and Information Disclosure Platform. Retrieved Aug 24, 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d