SHANGHAI, Nov. 11, 2021 /PRNewswire/ -- Everest Medicines and Gilead Sciences, Inc. (Nasdaq: GILD) jointly announces today that Everest Medicines sponsored (HKEX 1952.HK) Phase 2b EVER-132-001 study of sacituzumab govitecan (marketed as Trodelvy® in the United States) met its primary endpoint of overall response rate (ORR) in metastatic triple-negative breast cancer (TNBC).
EVER-132-001 is a single-arm, multi-center Phase 2b registrational study evaluating sacituzumab govitecan in 80 patients enrolled in China for the treatment of adults with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one for metastatic disease. The results demonstrated an ORR of 38.8% (CI: 95%) as evaluated by an Independent Review Committee. The safety profile of sacituzumab govitecan was similar to that reported in prior studies, and no new safety signals were identified.
The primary endpoint measured ORR according to RECIST v1.1 by an Independent Review Committee. The results were consistent with results demonstrated in the global Phase 3 ASCENT study. Gilead and Everest Medicines are engaged in a joint partnership for the development and commercialization of sacituzumab govitecan in Asia.
In May 2021, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) granted priority review to the Biologics License Application (BLA) for sacituzumab govitecan 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.
"These topline results confirm that sacituzumab govitecan has the potential to help change the treatment outlook for people in China living with mTNBC," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "These data, along with the benefit seen in the global ASCENT study, support its potential as a novel treatment for patients who currently have extremely limited options."
Kerry Blanchard, MD, PhD, CEO of Everest Medicines added, "With the goal of delivering treatment to as many patients as quickly as possible, we are building the commercialization team for Trodelvy in preparation for product launch in China."
"These data from the clinical trial of sacituzumab govitecan in China is extremely encouraging," said Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Research, Gilead Sciences. "We are confident in the potential of Trodelvy to help more women around the world."
Conference Call Information
Everest Medicines will host a conference call on Thursday 11 November 2021 at 8:30 AM Hong Kong Time (Wednesday 10 November 2021 at 7:30 PM US Eastern Time) to discuss the topline result from Phase 2b Registrational Trial of sacituzumab govitecan.
| Date: |
8:30am HKT, Thursday 11 November (7.30pm ET, Wednesday 10 November) 2021 |
| Hong Kong Toll Free dial-in: |
800-966-253 |
| Hong Kong International: |
+852 5819-4851 |
| Mainland China dial-in |
400-682-8609 |
| US/Canada Toll Free: |
+1-855-493-3549
|
| Conference ID: |
7449923 |
A replay will be available shortly after the call and can be accessed by visiting the Company's website at http://www.everestmedicines.com.
About Triple-Negative Breast Cancer (TNBC)
TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. TNBC is diagnosed more frequently in younger and premenopausal women and is more prevalent in Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.
About Sacituzumab Govitecan
Sacituzumab govitecan (Trodelvy) is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Trodelvy is approved in second-line metastatic TNBC in multiple countries worldwide, including Australia, Canada, Great Britain, Switzerland and the United States based on data submitted from the Phase 3 ASCENT study. Review is also underway in the European Union and Singapore and China through our partner Everest Medicines. Trodelvy is also approved for use in metastatic UC in the United States and continues to be developed for potential use in other TNBC and metastatic UC populations. It is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.
Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, sacituzumab govitecan 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.
The Ministry of Food and Drug Safety (MFDS) in South Korea has granted Fast Track Designation and Orphan Drug Designation (ODD) to sacituzumab govitecan for the treatment of metastatic TNBC. In addition, Everest announced in January 2021 that it submitted a New Drug Application (NDA) to the Health Sciences Authority (HSA) of Singapore for sacituzumab govitecan for the treatment of patients with metastatic TNBC who have received two prior therapies, at least one for metastatic disease. That application is currently under review.
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 ten 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.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.