On August 26, 2021 Everest Medicines (HKEX 1952.HK), 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, reported that the first person has been dosed in China as part of the global Phase 3 registration trial, TROPiCS-04, in metastatic urothelial cancer (UC) (Press release, Everest Medicines, AUG 26, 2021, View Source [SID1234586946]).
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The multicenter, open-label randomized controlled trial will evaluate sacituzumab govitecan-hziy (SG) compared with standard of care chemotherapeutic options in people with metastatic or locally advanced unresectable UC who have progressed after prior therapy with a platinum-based regimen and anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy. The trial includes two study arms to evaluate SG compared to treatment of physician’s choice (TPC). The primary endpoint of the trial is overall survival.
"We are excited to continue advancing development of SG for people in China with metastatic UC – a devastating and fatal disease that continues to experience increasing incidence in the region," said Dr. Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "This comprehensive and ongoing global study has the potential to add to the existing and robust suite of data already generated for this novel therapeutic candidate."
About Urothelial Cancer
Urothelial cancer is the one of the most common malignancies diagnosed in China, with the five-year survival rate of metastatic UC estimated to be only 4.6%.[1] There is a significant need for new treatment options for people with UC who have failed platinum-based chemotherapies and checkpoint inhibitors. Urothelial cancer begins in urothelial cells that line the urethra, bladder, ureters, renal pelvis, and some other organs that make up the urinary system. It is estimated that there are more than 80,000 new cases of UC and nearly 33,000 deaths from UC in China per year.[2]
About Sacituzumab Govitecan-hziy
Sacituzumab govitecan-hziy 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. SG received accelerated approval for advanced or metastatic UC following platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor in the U.S. in April 2021.