Everest Medicines Announces Taiwan, China,China FDA Has Accepted New Drug Application for Sacituzumab Govitecan in Second-Line Metastatic Triple-Negative Breast Cancer

Everest Medicines Limited (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Asia, announced today that Taiwan, China,China Food and Drug Administration (TFDA) has accepted the submission of a New Drug Application (NDA) for sacituzumab govitecan (SG) in adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. The treatment was granted Pediatric and Rare Severe Disease Priority Review Designation by the Taiwan, China,China FDA in July 2021.

"This regulatory milestone is another important step in the ongoing global development of sacituzumab govitecan as a novel treatment option for patients with mTNBC. We will be working with the regulatory authorities in Taiwan, China,China to help bring the treatment to patients with metastatic TNBC who have limited alternative options." said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines.

Under the trade name Trodelvy®, the U.S. FDA previously granted accelerated approval to SG in April 2020 and then expanded its indication with full approval in April 2021 for adult patients with unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. In May 2021, Everest announced that the China National Medical Products Administration accepted its Biologics License Application with priority review for SG for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

In November 2021, Everest announced topline results for its Phase 2b EVER-132-001 study of SG, which met its primary endpoint with a 38.8% overall response rate (ORR). This study included 80 people in China, and the results were consistent with those from the global Phase 3 ASCENT study, thus showing similar efficacy in the Chinese population.  

About Triple-Negative Breast Cancer (TNBC)

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

About Sacituzumab Govitecan

Sacituzumab govitecan (SG) is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. SG is approved for adults with metastatic TNBC in the United States, the European Union, Australia, Canada, Great Britain and Switzerland under the trade name Trodelvy® and approval is based on data submitted from the Phase 3 ASCENT study. Review is also underway in Singapore and China through Everest Medicines. Trodelvy is also approved for use in metastatic UC in the United States and continues to be developed for potential use in other TNBC and metastatic UC populations. It is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, sacituzumab govitecan was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

Followed by the Fast Track Designation and Orphan Drug Designation (ODD) to SG for the treatment of metastatic TNBC granted by the Ministry of Food and Drug Safety (MFDS) in South Korea, the NDA has been accepted in second-line mTNBC in December 2021. . In addition, Everest announced in January 2021 that it submitted a New Drug Application (NDA) to the Health Sciences Authority (HSA) of Singapore for SG for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. That application is currently under review.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of ten potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.

Source: Everest Medicines