The National Medical Products Administration of the People’s Republic of China has accepted Shanghai Fudan-Zhangjiang Bio-Pharmaceutical’s request to allow FDA018-ADC to enter in phase 1 clinical trial to study the safety, tolerability, and pharmacokinetics of FDA018-ADC for patients with advanced solid tumors.

FDA018-ADC is an antibody-drug conjugate drug conjugate (ADC) with an undisclosed payload and linker for Trop2 target. The investigational drug is intended to be developed for the treatment of patients diagnosed with a solid tumor.

Trop2, a cell-surface glycoprotein, is significantly overexpressed in various types of cancers, including breast cancer, with minimal expression in normal, healthy, tissues. Research shows that Trop2 may play a role in tumor progression given the involvement in several molecular pathways traditionally associated with cancer development. High Trop2 expression correlates with poor prognosis in a number of cancers, including pancreatic, hilar cholangiocarcinoma, cervical cancer, gastric cancer, and others.

The research goal of Fudan-Zhangjiang’s research team is to explore suitable indications and corresponding therapeutic windows.

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Currently, sacituzumab govitecan (Trodelvy®; Gilead), indicated for the treatment of adult patients with locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease or locally advanced or metastatic urothelial cancer, is the only Trop-2-directed antibody and topoisomerase inhibitor conjugate that has been approved by the US Food and Drug Administration (FDA).

Earlier this year, Genting Xinyao Oncology received approval from the National Pharmacopoeia Commission to use gosartuzumab as the Chinese generic name for sacituzumab govitecan. In April 2019 company signed an exclusive agreement with Everest Medicines, Gilead’s partner in Greater China and other Asian markets to develop, register, and commercialize all cancer indications for gosartuzumab in Greater China, South Korea, and some Southeast Asian countries.

In China and some other parts of Asia, the incidence of TROP2 expressing cancers is higher than that in Western countries, and the treatment options are limited, representing the major unmet medical need.

“The latest data we have available suggests that the incidence of TROP2 expressing cancers has exceeded 3,5 million patients, accounting for approximately 78% of all cancers in China, noted Shi Yang, Chief Medical Officer of Genting Xinyao Oncology

Additional registration
In December 2020 sacituzumab govitecan was submitted to the Health Sciences Authority in Singapore for a new drug marketing application for the treatment of metastatic triple-negative breast cancer that has received at least two systemic treatments. The application is currently under review.

The drug was granted orphan drug designation in April 2021 by the Korean Ministry of Food and Drug Safety for the treatment of metastatic triple-negative breast cancer.

Highlights of Prescribing Information
Sacituzumab govitecan (Trodelvy®; Gilead)[Prescribing Information]

Zaman S, Jadid H, Denson AC, Gray JE. Targeting Trop-2 in solid tumors: future prospects. Onco Targets Ther. 2019 Mar 1;12:1781-1790. doi: 10.2147/OTT.S162447. PMID: 30881031; PMCID: PMC6402435.

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