Phase IIb registrational study of sacituzumab govitecan conducted in China for metastatic triple-negative breast cancer.

EVER-132-001 is a single-arm, multi-center Phase IIb registrational study evaluating sacituzumab govitecan in 80 patients enrolled in China for the treatment of adults with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one for metastatic disease. The results demonstrated an ORR of 38.8% (CI: 95%) as evaluated by an Independent Review Committee. The safety profile of sacituzumab govitecan was similar to that reported in prior studies, and no new safety signals were identified.

The primary endpoint measured ORR according to RECIST v1.1 by an Independent Review Committee. The results were consistent with results demonstrated in the global Phase III ASCENT study. Gilead and Everest Medicines are engaged in a joint partnership for the development and commercialization of sacituzumab govitecan in Asia.

In May 2020, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) granted priority review to the Biologics License Application (BLA) for sacituzumab govitecan 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.

Everest Medicines plans to submit a marketing application for Trodelvy in China by the end of 2021.