Everest Medicines Announces that Licensing Partner Gilead Sciences' Phase 3 TROPiCS-02 Study Meets Primary Endpoint of Progression-Free Survival in Late-Line HR+/HER2- Metastatic Breast Cancer
Foster City, Calif., and Shanghai, China, March 12, 2022 – Everest Medicines (HKEX 1952.HK) announces that its licensing partner, Gilead Sciences, Inc. (Nasdaq: GILD) recently disclosed results from the Phase 3 TROPiCS-02 study evaluating Trodelvy ®(sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The study met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus physician’s choice of chemotherapy.
The trial targeted a 30% reduction in the risk of disease progression or death. The primary endpoint results were consistent with those observed in the Phase 1/2 IMMU-132-01 study in a subset of HR+/HER2- metastatic breast cancer patients.
The first interim analysis of the key secondary endpoint of overall survival in the TROPiCS-02 study also demonstrated a trend in improvement for overall survival. Patients will be followed for subsequent overall survival analysis. The safety profile for Trodelvy was consistent with prior studies, and no new safety concerns emerged in this patient population. Detailed results from TROPiCS-02 will be presented at an upcoming medical conference.
“Trodelvy demonstrated consistent activity in this difficult-to-treat patient population,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We are evaluating the data and will explore potential pathways with regulatory authorities to bring Trodelvy to this group of patients. As we work to expand the patient benefit of Trodelvy beyond its current indications for second-line metastatic triple-negative breast cancer and accelerated approval in second-line metastatic bladder cancer, we are pursuing studies across multiple tumor types and earlier lines of therapy.”
Everest Medicines is conducting a Phase 3 registrational Asian study EVER-132-002 evaluating Trodelvy versus physician’s choice of chemotherapy in people with HR+/HER2− metastatic breast cancer, which is enrolling patients with HR+/HER2- metastatic breast cancer in China mainland, Taiwan and South Korea.
“The unmet need in late-line metastatic HR+/HER2- breast cancer remains significant,” said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. “We wait in anticipation for the results from our Phase 3 trial in Asia.”
About the TROPiCS-02 Study
The TROPiCS-02 study is a global, multicenter, open-label, Phase 3 study, randomized 1:1 to evaluate Trodelvy versus physician’s choice of 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.The primary endpoint is progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by blinded independent central review for participants treated with Trodelvy compared to those treated with chemotherapy. The trial targets a 30% reduction in the risk of disease progression or death and is powered to detect a statistically significant difference of at least 0.9 months in median PFS. Secondary endpoints include overall survival, duration of response, clinical benefit rate and overall response rate as well as assessment of safety and tolerability and quality of life measures. More information about TROPiCS-02 is available at https://clinicaltrials.gov/ct2/show/NCT03901339.
About HR+/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 and accounts for approximately 70% of all new cases, or nearly 400,000 diagnoses worldwide each year. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 30%.As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy. For patients treated with single-agent chemotherapy, the prognosis is poor.
Trodelvy® (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.
Trodelvy is approved in more than 35 countries, with multiple additional regulatory reviews underway worldwide, 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. Trodelvy is also approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Trodelvy is also being developed for potential investigational use in other TNBC and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, 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.
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 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 eleven 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.
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