— The EVER-132-001 trial met its primary endpoint with an objective response rate of 38.8% —
FOSTER CITY, Calif., & SHANGHAI–(BUSINESS WIRE)– Gilead Sciences, Inc. (Nasdaq: GILD) today reported that the Everest Medicines (HKEX 1952.HK) sponsored Phase 2b EVER-132-001 study of sacituzumab govitecan (marketed as Trodelvy® in the United States) met its primary endpoint of overall response rate (ORR) in metastatic triple-negative breast cancer (TNBC).
EVER-132-001 is a single-arm, multi-center Phase 2b 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 3 ASCENT study. Gilead and Everest Medicines are engaged in a joint partnership for the development and commercialization of sacituzumab govitecan in Asia.
In May 2021, 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.
“These topline results confirm that sacituzumab govitecan has the potential to help change the treatment outlook for people in China living with mTNBC,” said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. “These data, along with the benefit seen in the global ASCENT study, support its potential as a novel treatment for patients who currently have extremely limited options.”
Kerry Blanchard, MD, PhD, CEO of Everest Medicines added, “With the goal of delivering treatment to as many patients as quickly as possible, we are building the commercialization team for Trodelvy in preparation for product launch in China.”
“These data from the clinical trial of sacituzumab govitecan in China are extremely encouraging,” said Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Research, Gilead Sciences. “We are confident in the potential of Trodelvy to help more women around the world.”
The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.