Everest Medicines Announces China NMPA Has Accepted Biologics License Application for Sacituzumab Govitecan-Hziy in Metastatic Triple-Negative Breast Cancer

Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Greater China and other parts of Asia, announced today that the China National Medical Products Administration (NMPA) has accepted for review its Biologics License Application for sacituzumab govitecan-hziy (SG), an investigational therapy 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.

"This aggressive and difficult-to-treat disease has historically had very limited treatment options, with overall survival remaining unchanged among patients for nearly two decades," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "The outstanding and robust efficacy and safety results from the global Phase 3 ASCENT study demonstrate SG is an important potential new treatment option for people in China with metastatic TNBC."  

"We are excited to achieve this important milestone as we work to advance access to this first-of-its-kind therapy for patients with metastatic TNBC in China and the Asia Pacific region. The speed at which this milestone is achieved is a testament to our steadfast commitment to accelerating global pharmaceutical innovation in diseases with critical unmet needs," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines.

Under the trade name Trodelvy®, the U.S. Food and Drug Administration previously granted accelerated approval to SG in April 2020 and full approval in April 2021 for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The Ministry of Food and Drug Safety in South Korea has also recently granted Fast Track Designation and Orphan Drug Designation to SG for the treatment of metastatic TNBC. In addition, Everest announced in January 2021 that it submitted a New Drug Application to the Health Sciences Authority of Singapore for SG 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% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in Asian 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 Sacituzumab Govitecan-hziy

Sacituzumab govitecan-hziy (SG) is a first-in-class antibody and topoisomerase inhibitor conjugate directed at TROP-2, a protein frequently expressed in multiple types of epithelial cancers. SG is approved in the United States under the trade name Trodelvy®. The U.S. approval was supported by data from the Phase 3 ASCENT study, which demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival or 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). SG 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.

The most frequent Grade ≥3 adverse reactions for SG compared to single-agent chemotherapy in the study were neutropenia (52% vs. 34%), diarrhea (11% vs. 1%), leukopenia (11% vs. 6%) and anemia (9% vs. 6%). Adverse reactions leading to treatment discontinuation occurred in 5% of patients receiving SG. The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG 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.