Gilead Announces Positive Topline Results from Phase 3 TROPiCS-02 Study of Trodelvy® in Heavily Pretreated HR+/HER2- Metastatic Breast Cancer

Foster City, California, and Shanghai, June 4, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK) today announced positive results from the primary analysis of the Phase 3 TROPiCS-02 study conducted by its licensing partner Gilead Sciences (Nasdaq: GILD). The study aims to evaluate Trodelvy® (sacituzumab govitecan) in patients who have previously received endocrine therapy, CDK4/6 inhibitors, and two to four lines of high-intensity chemotherapy.HR+/HER2-Efficacy compared to physician's choice of standard chemotherapy (TPC) in patients with metastatic breast cancer.

The study met the primary endpoint of progression-free survival (PFS), reducing the risk of disease progression or death by 34%, with statistical significance and clinical relevance (median PFS 5.5 months vs. 4 months; HR: 0.66; 95% CI: 0.53-0.83; P<0.0003). The first interim analysis of overall survival (OS), a key secondary endpoint, showed a trend toward improvement. These data are not yet mature, and patients will be followed up for subsequent overall survival analysis. These findings will be presented in an oral session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA1001).

Studies show that, compared to patients receiving standardized chemotherapy chosen by their doctors, the number of patients without disease progression after one year of treatment with Trodelvy was three times higher (21% vs. 7%, respectively). The improvement in progression-free survival with Trodelvy was consistently observed across key subgroups, including patients who had previously received three or more chemotherapy regimens for metastatic disease (HR: 0.70; CI: 0.52-0.95), patients with visceral metastases (HR: 0.66; CI: 0.53-0.83), and elderly patients (≥65 years; HR: 0.59; CI: 0.38-0.93).

Dr. Hope Rugo, Professor of Medicine at the University of California, San Francisco Comprehensive Cancer Center and Director of Breast Oncology and Clinical Trial Education, stated: "For patients with HR+/HER2- metastatic breast cancer, nearly all cases inevitably develop resistance to endocrine therapy, and standard treatment is limited to sequential single-agent chemotherapy, which leads to a decline in response rates, disease control rates, and quality of life. In the TROPiCS-02 study, we enrolled heavily pretreated metastatic breast cancer patients who experienced disease progression after multiple lines of chemotherapy. Observing a clinically meaningful reduction in the risk of disease progression or death in these patients with limited treatment options is highly significant. Sacituzumab govitecan will become an important potential treatment option for these patients."

The safety profile of Trodelvy was consistent with previous studies, and no new safety issues were identified in this patient population. The most common ≥3 grade treatment-related adverse reactions for Trodelvy compared to physician’s choice of standard chemotherapy were neutropenia (51% vs. 38%), diarrhea (9% vs. 1%), leukopenia (9% vs. 5%), anemia (6% vs. 3%), fatigue (6% vs. 2%), and febrile neutropenia (5% vs. 4%).

Everest Medicines is conducting a Phase 3 registrational study, EVER-132-002, in Asia to evaluate the efficacy of Trodelvy compared to physician’s choice of standard chemotherapy in treating HR+/HER2- metastatic breast cancer patients. The study is currently enrolling HR+/HER2- metastatic breast cancer patients in mainland China, Taiwan, and South Korea.

Everest Medicines' Chief Medical Officer of Oncology/Immunology, Yang Shi, stated: "The data from the Phase 3 TROPiCS-02 study conducted by our partners further demonstrates the potential of Trodelvy to benefit more breast cancer patients. We are highly anticipating the results of the clinical study in Asia."

AboutTROPiCS-02Research 

The TROPiCS-02 study is a global, multicenter, open-label Phase 3 study designed to evaluate the efficacy of Trodelvy compared to physician’s choice of standard chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine) in 543 patients with HR+/HER2- metastatic breast cancer who were previously treated with endocrine therapy, CDK4/6 inhibitors, and two to four lines of chemotherapy, randomized in a 1:1 ratio. The primary endpoint is progression-free survival, assessed through blinded, independent, centralized review of patients receiving Trodelvy and chemotherapy, according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1). Secondary endpoints include overall survival, duration of response, clinical benefit rate, overall response rate, as well as safety, tolerability, and quality-of-life assessment outcomes. For more information on TROPiCS-02, please visithttps://clinicaltrials.gov/ct2/show/NCT03901339。

AboutHR+/HER2- Breast Cancer

Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) breast cancer is the most common type of breast cancer, accounting for approximately 70% of all new cases, or nearly 400,000 diagnosed cases globally each year. Nearly one-third of early-stage breast cancer cases will eventually progress to metastatic disease, and in patients with HR+/HER2- metastatic breast cancer, the 5-year relative survival rate is 30%. As patients with HR+/HER2- metastatic breast cancer develop resistance to endocrine therapy, their primary treatment options are limited to single-agent chemotherapy. However, the prognosis for patients receiving single-agent chemotherapy remains poor.

AboutTrodelvy ®

Trodelvy® (Sacituzumab Govitecan) is a first-in-class antibody-drug conjugate targeting the Trop-2 receptor, a cell surface antigen overexpressed in many types of tumors, including over 90% of breast and bladder cancers. Trodelvy specifically features a hydrolyzable linker connected to the payload, the topoisomerase I inhibitor SN-38. This unique design ensures potent activity in Trop-2 expressing cells and the adjacent microenvironment.

Trodelvy has been approved in more than 35 countries/regions for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies, including at least one for metastatic disease. Globally, Trodelvy is also undergoing additional regulatory reviews. In the United States, Trodelvy has received accelerated approval for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-based chemotherapy and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

Trodelvy is also under development for the following populations: other TNBC and metastatic UC, as well as a range of tumor types with Trop-2 overexpression, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.

Under the license agreement with Gilead Sciences, Everest Medicines has exclusive rights to develop, register, and commercialize Trodelvy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

TRODELVY is a trademark used under license from Gilead Sciences, Inc.

About Everest Medicines 

Everest Medicines is a biopharmaceutical company focused on the development and commercialization of innovative medicines, dedicated to addressing unmet medical needs in the Asian market. The management team of Everest Medicines has deep expertise and extensive experience in high-quality clinical development, regulatory affairs, chemistry manufacturing and control (CMC), business development, and operations within both Asian and global pharmaceutical enterprises. Everest Medicines has built a portfolio of 11 potential first-in-class or best-in-class drugs globally, most of which are already in the late stages of clinical trials. The company’s therapeutic areas include oncology, autoimmune diseases, cardio-renal diseases, and infectious and contagious diseases. For more information, please visit the company's website:www.everestmedicines.com。

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