Everest Medicines Announces First Person Dosed in Global Phase 3 Registration Trial of Sacituzumab Govitecan-Hziy in China for Metastatic Urothelial Cancer

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Aug 26, 2021, 09:23 ET

SHANGHAI, Aug. 26, 2021 /PRNewswire/ -- 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, announced today 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).

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.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.

[1] Cumberbatch MGK, Noon AP. Epidemiology, etiology and screening of bladder cancer. Transl-Androl-Urol. 2019;8(1):5–11. doi:10.21037/tau.2018.09.11

[2] Chinese guidelines for diagnosis and treatment of urothelial carcinoma of bladder 2018 (English version). Chin J Cancer Res. 2019 Feb;31(1):49-66.

SOURCE Everest Medicines