Everest Medicines Announces Approval of Clinical Trial Application by China National Medical Products Administration for Phase 3 Registration Trial of Sacituzumab Govitecan-Hziy for Metastatic Urothelial Cancer

On January 6, 2021, Everest Medicines (HKEX 1952.HK) announced that the National Medical Products Administration (NMPA) of the People’s Republic of China 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.  Patients will be randomized to receive either sacituzumab govitecan-hziy or Treatment of Physician’s Choice (TPC), including paclitaxel, docetaxel, and vinflunine.  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.

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

The press release states that sacituzumab govitecan-hziy showed positive results in the pivotal Phase 2 TROPHY U-01 study, that “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).”  Everest Medicines reported that 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 pretreated patients with mUC. Sacituzumab govitecan-hziy has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in this indication.