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Everest Medicines Secures Breast Cancer Drug Approval in China

by Joy Lin
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Everest Medicines has announced the approval of Trodelvy (sacituzumab govitecan), its antibody-drug conjugate (ADC) for triple-negative breast cancer (TNBC) by China’s National Medical Products Administration (NMPA). Trodelvy is Everest’s first product to be approved to launch in China, and will be used to treat adult patients with TNBC with tumors that cannot be surgically removed, or has metastasized, after they have received two or more prior systemic therapies, at least one of them for metastatic disease. 

“The NMPA approval of Trodelvy will provide an important and new treatment option for Chinese women with metastatic triple-negative breast cancer – a very aggressive and challenging to treat form of the disease. We would like to thank the investigators and patients who participated in the clinical trials for making this possible,” said Yang Shi, Chief Medical Officer for Oncology/Immunology at Everest Medicines. 

“We will continue to work with our partner, Gilead, to advance clinical research of Trodelvy across multiple tumor types as well as earlier lines of therapy,” Shi said.

 

Overall Response Rate of 38.8% in Triple-Negative Breast Cancer

 

Last November, Everest reported its Phase 2b EVER-132-001 China study of Trodelvy in 80 people met its primary endpoint with an overall response rate (ORR) of 38.8%. The results were in line with those from the global Phase 3 ASCENT study, showing similar efficacy and safety in the Chinese population. 

According to a statement from Kevin Guo, Chief Commercial Officer at Everest, the company will rapidly expand their sales team to launch Trodelvy in Q4 of 2022 and “bring it to as many hospitals and patients in China as possible”.

Besides China, Everest is also seeking approval for Trodelvy in South Korea, Taiwan, and Hong Kong, for the same TNBC indication. 

Last December, separate NDAs for Trodelvy were accepted for review in South Korea and Taiwan. In March 2022, Everest submitted an NDA for Trodelvy for second-line metastatic TNBC in Hong Kong.

Trodelvy has been approved in Singapore since January 2022 for the treatment of second-line and later-line metastatic TNBC. 

Related article: ASCO 2022: AstraZeneca, Pfizer, Novartis Share Key Data on Breast Cancer Therapeutics 

 

Trop-2 Directed ADC

 

Trodelvy is a Trop-2 directed ADC. Trop-2 is a cell surface antigen highly expressed in multiple tumor types such as breast and bladder cancers. 

Designed with a hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload, Trodelvy acts potently on both Trop-2 expressing cells and the micro environment. 

The drug has been approved in the US under the accelerated approval pathway for the treatment of metastatic urothelial cancer (UC), and is also being investigated for other TNBC and metastatic UC patient populations. 

The drug was originally developed by Immunomedics, and licensed to Everest for development and commercialization in China, South Korea, and certain Southeast Asian countries. Gilead inherited the licensing agreement with Everest after its $21 billion-plus buyout of Immunomedics in 2020, which was mainly motivated by Trodelvy’s potential. 

According to a recent financial statement from Gilead, global sales of Trodelvy increased 103% to $146 million in Q1 of 2022 compared to 2021 in the same period.

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