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Immunomedics' Trodelvy Enters Phase II Triple-Negative Breast Cancer Trial in China

NEW YORK – Everest Medicines on Tuesday announced that the first patient in China had been dosed with sacituzumab govitecan (Immunomedic's Trodelvy) in a registration trial evaluating the treatment for metastatic triple-negative breast cancer.

In the Phase II trial, dubbed EVER-132-001, approximately 80 metastatic TNBC patients in China who have received at least two prior lines of therapy will receive sacituzumab govitecan, and the investigators will assess the patients' objective response rates as a primary endpoint. The agent, an antibody-drug conjugate, is designed to target Trop-2, a cell-surface protein that is commonly overexpressed on TNBC cells.

In 2019, sacituzumab govitecanan's developer Immunomedics — now a subsidiary of Gilead — entered into an exclusive licensing agreement with the New York-headquartered biopharmaceutical firm, which put Everest in charge of the drug's development and commercialization in China, South Korea, and certain additional Southeast Asian countries.

"The large patient population with metastatic TNBC in China represents a huge unmet medical need where few therapies besides the standard cytotoxic chemotherapy are available," Yang Shi, Everest's chief medical officer for oncology, said in a statement. "Clinical data generated to date suggest that sacituzumab govitecan could enable a new standard of care for patients with pre-treated, metastatic TNBC."

In April 2020, the US Food and Drug Administration granted sacituzumab govitecanan accelerated approval as a treatment for previously treated, metastatic TNBC patients based on the results of a single-arm, Phase II study. Results from a confirmatory Phase III study, called ASCENT, subsequently demonstrated further evidence of the drug's efficacy in July.