Everest Medicines, 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 that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China has approved a Clinical Trial Application (CTA) for sacituzumab govitecan-hziy for the treatment of patients with metastatic urothelial cancer (mUC).

With this CTA, Everest Medicines plans to enroll patients in China as part of the Phase 3, global, multicenter, open-label randomized controlled TROPiCS-04 trial. The trial will evaluate sacituzumab govitecan-hziy compared with standard of care chemotherapeutic options in subjects with metastatic or locally advanced unresectable urothelial cancer 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.  Subjects will be randomized to receive either sacituzumab govitecan-hziy or Treatment of Physician's Choice (TPC), including paclitaxel, docetaxel, and vinflunine.

Positive results from the pivotal Phase 2 TROPHY U-01 study of sacituzumab govitecan-hziy in 113 mUC patients, presented at the ESMO 2020 annual conference, confirmed earlier study results showing sacituzumab govitecan-hziy has significant activity and is safe in patients with heavily pretreated mUC who progressed on both platinum-based chemotherapy and checkpoint inhibitors (CPI). Results from the study showed that sacituzumab govitecan-hziy achieved a 27% overall response rate (ORR) and a median duration of response (DOR) of 5.9 months in heavily pre-treated patients with mUC. Sacituzumab govitecan-hziy has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in this indication.

"Based on the compelling results generated to date, we believe that sacituzumab govitecan-hziy has the potential to offer patients with mUC a new treatment option, which may advance current standards of care and treatment," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "Urothelial cancer is one of the most common urologic malignancies in China, with both incidence and mortality rates gradually increasing in recent years. We look forward to working with investigators and patients to initiate this study in China."

About Urothelial Cancer

Urothelial cancer is a type of cancer that begins in urothelial cells that line the urethra, bladder, ureters, renal pelvis, and some other organs that make up the urinary system. According to Frost & Sullivan, in 2019, the incidence of urothelial cancer reached 76.4 thousand in China. 

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. Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan-hziy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

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.