SHANGHAI, April 9, 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 U.S. Food and Drug Administration (FDA) has granted full approval of Trodelvy® (sacituzumab govitecan-hziy) to Gilead Sciences, Inc. (Nasdaq: GILD), a licensing partner of Everest Medicines, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
The approval is supported by data from the Phase 3 ASCENT study. In this study, Trodelvy® demonstrated statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). Trodelvy® also extended median overall survival (OS) to 11.8 months vs. 6.9 months (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), representing a 49% reduction in the risk of death.
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.
"This first-of-its kind approval for metastatic TNBC, a devastating disease with previously limited treatment options, marks an exciting milestone for patients in the U.S. and around the world," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "We applaud Gilead Sciences for its extensive and encouraging datasets, which validate the clinical benefit of this novel therapy, as well as its comprehensive and ongoing global regulatory strategy. At Everest Medicines, we look forward to continuing to advance late-stage development of sacituzumab govitecan-hziy for patients in Greater China and other parts of Asia as part of the collective effort to make this important and innovative treatment available to patients around the world."
Everest Medicines is currently conducting a Phase 2b pivotal trial of sacituzumab govitecan-hziy for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease in China. In addition, Everest announced in January 2021 that it has initiated the submission of a New Drug Application (NDA) to the Health Sciences Authority (HSA) of Singapore for sacituzumab govitecan-hziy also for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. That application is currently under review.
About Triple-Negative Breast Cancer
Triple-Negative Breast Cancer (TNBC) is a highly aggressive disease and accounts for approximately 15-20% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in China than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.
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 unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
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. In October 2020, sacituzumab govitecan-hziy was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.
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.