Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced that the National Medical Products Administration (NMPA) of the People’s Republic of China has approved a Clinical Trial Application (CTA) for Trodelvy (sacituzumab govitecan) for the treatment of patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC) who have failed at least two prior chemotherapy regimens.

With this CTA, Everest Medicines plans to initiate its Phase 3 registration clinical trial, EVER-132-002, designed to assess and compare the efficacy and safety of sacituzumab govitecan versus Treatment of Physician’s Choice (TPC) in Asian patients with HR+/HER2- mBC who received at least two, and no more than four, systemic chemotherapy regimens. The trial will enroll approximately 330 HR+/HER2- mBC patients in Mainland China, Taiwan and South Korea.

“HR+/HER2- breast cancer accounts for more than 60% of all breast cancers in China, and while there have been significant therapeutic advances over the years, treatment options remain extremely limited for women with this subset of metastatic disease,” said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. “The late-stage data generated on sacituzumab govitecan to date, along with recently updated breast cancer treatment clinical guidelines in China, which now include this important therapy, reinforce the promising clinical activity of sacituzumab govitecan in HR+/HER2− mBC patients. We are excited to build on this comprehensive legacy of research and data to help advance standards of care for patients in Asia.”

“We look forward to initiating this Phase 3 registration trial as we progress clinical development for this innovative therapy – which represents advanced standards of care in other parts of the world – and as we work to also make it available to patients in Asia for whom prior therapies have not been effective,” stated Kerry Blanchard, MD, PhD, CEO of Everest Medicines.

In April of 2020, the US FDA granted accelerated approval to sacituzumab govitecan for the treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease based on results from a Phase 1/2 clinical trial. Recently, the confirmatory Phase 3 ASCENT trial confirmed that sacituzumab govitecan significantly improved progression free survival (PFS) and overall survival (OS) over a standard single-agent chemotherapy in pre-treated mTNBC patients. Immunomedics (now part of Gilead Sciences, Inc.), which developed sacituzumab govitecan, is currently recruiting 400 patients for the TROPiCS-02 trial, an open-label, randomized, multi-center Phase 3 study to compare the efficacy and safety of sacituzumab govitecan versus the TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- mBC, after failure of at least two, and no more than four, prior chemotherapy regimens for metastatic disease.

In October 2020, sacituzumab govitecan was included in the updated 2020 Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer in China, 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.

HR+/HER2- breast cancer is the most common form of breast cancer in China, representing over 60% of all breast cancer cases. This subtype of breast cancer grows in connection with estrogen or progesterone and is likely to respond to hormone therapies initially, but almost all HR+/HER2- mBC become refractory over time.

Sacituzumab govitecan is a first-in-class antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. Sacituzumab govitecan was granted accelerated approval by the U.S. FDA in April 2020 for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. In September 2020 at the ESMO 2020 annual conference, Immunomedics (now part of Gilead Sciences, Inc.) presented the confirmatory Phase III trial (ASCENT) demonstrating that sacituzumab govitecan significantly improved PFS and OS over standard single agent chemotherapy in pre-treated mTNBC patients with HR=0.41 and 0.48, respectively. Under a licensing agreement with Immunomedics, 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.