Everest Medicines announced the first patient has been dosed in the Phase 3 registration Asian study EVER-132-002 evaluating TrodelvyTM (sacituzumab govitecan) versus treatment of physician’s choice (TPC) in subjects with hormonal receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2?) metastatic breast cancer (mBC).

EVER-132-002 is a Phase 3 Asian study designed to assess and compare the efficacy and safety of sacituzumab govitecan versus 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 up to 330 HR+/HER2- mBC patients in China mainland, Taiwan, China and South Korea. The primary endpoint is progression free survival (PFS) per RECIST v 1.1 by an Independent Review Committee.

“HR+/HER2- breast cancer is the most prevalent subtype of breast cancer and accounts for more than 60% of all breast cancer cases. There is a significant unmet need for new treatment options for women with HR+/HER2? mBC who have failed initial standard-of-care chemotherapies,” said Dr. Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. “The clinical data generated to date suggested promising clinical activity of sacituzumab govitecan in HR+/HER2? mBC patients who have failed at least two chemotherapy regimens. We are very excited to initiate our Phase 3 registration trial as we believe sacituzumab govitecan has tremendous potential to become the new standard of care in patients with pre-treated HR+/HER2? mBC.”

Immunomedics (now part of Gilead Sciences), which developed sacituzumab govitecan, is currently recruiting 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.

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 ESMO2020 annual conference, Immunomedics (now part of Gilead Sciences, Inc.) presented the confirmatory Phase 3 trial results (ASCENT) demonstrating that sacituzumab govitecan significantly improved progression free survival (PFS) and overall survival (OS) over standard single agent chemotherapy in pre-treated metastatic triple-negative breast cancer (mTNBC) patients with a hazard ratio of 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.

Hormone Receptor Positive, HER2 Negative (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- metastatic breast cancers become refractory over time.