On December 14, 2021 Everest Medicines Limited (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that the Ministry of Food and Drug Safety (MFDS) of South Korea accepted its New Drug Application (NDA) for Sacituzumab Govitecan ("SG") for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease (Press release, Everest Medicines, DEC 14, 2021, View Source [SID1234597153]).
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The MFDS in South Korea previously granted Fast Track Designation and Orphan Drug Designation to SG for the treatment of mTNBC in April 2021.
"We’re extremely proud of this acceptance as breast cancer is the leading cause of death from cancer in South Korean women and one of the fastest growing cancers in the world," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "Historically, women with metastatic TNBC have had fewer treatment options available and this application acceptance means we are one step closer in making SG available for women with this aggressive cancer in South Korea."
Under the trade name Trodelvy, the U.S. FDA previously granted accelerated approval to SG in April 2020 and then expanded its previous 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 BLA 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 evaluated 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 govitecanis (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 mTNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. SG is approved for adults with second-line 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 under the accelerated approval pathway 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.
SG was also granted Pediatric and Rare Severe Disease Priority Review Designation by the Taiwan Food and Drug Administration (FDA) in July 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 two prior therapies, at least one for metastatic disease. That application is currently under review.
Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG 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.