On March 30, 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 China National Medical Products Administration (NMPA) approved its Clinical Trial Application (CTA) for a Phase 2 basket trial of Trodelvy (sacituzumab govitecan-hziy) in a variety of cancers with high TROP-2 expression (Press release, Everest Medicines, MAR 30, 2021, View Source [SID1234577385]).
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The Phase 2 single arm, multiple-cohorts basket trial will evaluate sacituzumab govitecan-hziy in 180 patients with relapse/refractory esophageal squamous cell carcinoma, gastric cancer, and cervical cancer at selected sites in China. The incidence of these indications is higher in China/Asia than Western countries, and there are very limited treatment options in later line settings, represent a significant unmet medical need in China and Asia.
"As of 2019, the incidence of cancers with TROP-2 expression was more than 3.5 million, accounting for approximately 78% of all cancer occurrences in China," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "Sacituzumab govetican-hziy’s unique TROP-2 directed antibody and topoisomerase inhibitor drug conjugate mechanism of action, along with its robust set of data in other TROP-2 expressing cancers suggest that it may be effective in a broad range of tumors. We look forward to advancing this important basket study as we work to expand potential indications of this novel therapy across a variety of cancers with high unmet medical need."
About Trodelvy (sacituzumab govitecan-hziy)
Trodelvy (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. It is indicated in the U.S. for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease and was granted accelerated approval by the U.S. Food and Drug Administration for this patient population in April 2020, based on overall response rate and duration of response results in a Phase 1/2 study.
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.