Everest Medicines and Gilead Sciences Announce Phase 2b Trial of Sacituzumab Govitecan Met Primary Endpoint of Overall Response Rate in Chinese Patients with Metastatic Triple-Negative Breast Cancer

Foster City, California, USA and Shanghai, China, November 11, 2021 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK) and Gilead Sciences (Nasdaq: GILD) today jointly announced that Everest Medicines has initiated its program for Sacituzumab Govitecan (marketed as Trodelvy in the United States).^®The Phase 2b EVER-132-001 study evaluating (product name) for the treatment of metastatic triple-negative breast cancer (TNBC) met its primary endpoint of overall response rate (ORR).

EVER-132-001 is a single-arm, multi-center Phase 2b registrational study evaluating the efficacy of sacituzumab govitecan in treating adult patients with unresectable locally advanced or metastatic triple-negative breast cancer in China. The study involved 80 patients who had previously received at least two systemic treatments, including at least one for metastatic disease. The overall response rate (ORR) assessed by an independent review committee was 38.8% (Confidence Interval CI: 95%). The safety profile of sacituzumab govitecan was consistent with that reported in previous studies, with no new safety signals identified.

The primary endpoint of the study was the overall response rate assessed by an independent review committee according to RECIST (Response Evaluation Criteria in Solid Tumors) v1.1. The results were consistent with those shown in the global Phase 3 ASCENT study. Gilead Sciences and Everest Medicines have established a joint partnership for the development and commercialization of sacituzumab govitecan in Asia.

May 2021,Center for Drug Evaluation, National Medical Products Administration of ChinaAccepted the Biologics License Application (BLA) for sacituzumab govitecan for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic therapies, including at least one for metastatic disease, and it has been designated for priority review.

Everest Medicines' Chief Medical Officer in the oncology field, Yang Shi, stated, "These pivotal results confirm our belief that sacituzumab govitecan has the potential to be a transformative treatment option for patients with metastatic triple-negative breast cancer. The data, along with the benefits observed in the global ASCENT study, demonstrate that sacituzumab govitecan will offer a novel therapeutic approach for patients who currently have limited treatment options."

Everest Medicines CEO Dr. Kerry Blanchard emphasized: "To provide treatment to as many patients as possible as soon as possible, we are accelerating the establishment of the Trodelvy commercialization team to prepare for the product's launch in China."

Bill Grossman, MD, Senior Vice President of Clinical Research in Oncology at Gilead Sciences, stated, "The data obtained from the clinical trials of sacituzumab govitecan conducted in China are very encouraging. We firmly believe that Trodelvy will help more female patients worldwide."

Teleconference Information: 

Everest Medicines will host a conference call at 8:30 AM Beijing Time on Thursday, November 11 (7:30 PM Eastern Time on Wednesday, November 10) to share the pivotal results from the Phase 2b registrational study of Sacituzumab Govitecan in China.

Date:

Everest Medicines will hold the event at 8:30 AM Beijing Time on Thursday, November 11 (7:30 PM Eastern Time on Wednesday, November 10 in the United States).

Hong Kong Toll-Free Number:

800-966-253

Hong Kong International Dial-in Number:

+852 5819-4851

China Dial-in Number:

400-682-8609

US/Canada Toll-Free Number:

+1-855-493-3549

Meeting Code:

7449923

After the meeting, you can visit the Everest Medicines official website (www.everestmedicines.com) Listen to the conference replay.

About Triple-Negative Breast Cancer (TNBC）

Triple-negative breast cancer is a highly aggressive form of breast cancer, accounting for approximately 15% of all breast cancer types globally. Triple-negative breast cancer is more frequently diagnosed in younger and premenopausal women.Black RaceAnd it is more common among Hispanic women. Triple-negative breast cancer tumors lack sufficient estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2). Due to the nature of triple-negative breast cancer, the effective treatment options are extremely limited compared to other types of breast cancer. Triple-negative breast cancer has a higher chance of recurrence and metastasis than other types of breast cancer. The average time for recurrence and metastasis of triple-negative breast cancer is about 2.6 years, while for other breast cancers, it is 5 years, with a much lower relative five-year survival rate.The 5-year survival rate for women with metastatic TNBC is 12%, compared to 28% for other types of metastatic breast cancer.

About Sacituzumab Govitecan（Sacituzumab Govitecan）

Sacituzumab Govitecan (Trodelvy) is a first-in-class antibody-drug conjugate composed of an antibody and a topoisomerase inhibitor, targeting the TROP-2 receptor—a protein overexpressed in many epithelial cancers, including metastatic triple-negative breast cancer (TNBC) and metastatic urothelial cancer (UC). High expression of TROP-2 is associated with low survival rates and recurrence. Based on data from the Phase 3 ASCENT study, Trodelvy has been approved in multiple countries worldwide, including the United States, Australia, Canada, the United Kingdom, Switzerland, and others, for second-line treatment of metastatic TNBC. The European Union is currently reviewing its approval, while in China and Singapore, the application is being submitted through Everest Medicines. Trodelvy has also been approved in the United States for treating patients with metastatic UC and is being further developed for other TNBC and metastatic UC patients. It is also under investigation as a treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer (NSCLC). Additional evaluations for various solid tumors are ongoing.

According to the licensing agreement signed with Gilead Sciences, 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 2020 edition of the "Guidelines for Standardized Diagnosis and Treatment of Advanced Breast Cancer in China," which was jointly 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 Clinical Research Professional Committee on Anticancer Drugs of the Chinese Anti-Cancer Association.

South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted Sacituzumab Govitecan a Fast Track Designation and Orphan Drug Designation (ODD) for the treatment of metastatic triple-negative breast cancer. Additionally, in January 2021, Everest Medicines announced that it had submitted a New Drug Application (NDA) to Singapore’s Health Sciences Authority (HSA) for Sacituzumab Govitecan to treat patients with metastatic triple-negative breast cancer who have received at least two prior lines of therapy, including at least one treatment for metastatic disease. The application is currently under review.

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 pharmaceutical enterprises across Asia and globally. Everest Medicines has built a portfolio of 10 potential first-in-class or best-in-class drugs, most of which are already in the late stages of clinical trials. The company’s therapeutic areas include oncology, autoimmune diseases, cardiorenal diseases, and infectious and contagious diseases. For more information, please visit the company's website:www.everestmedicines.com。

Regarding Gilead Sciences (Gilead Sciences）

Gilead Sciences is a biopharmaceutical company that has been committed to breakthroughs in the field of medicine for more than three decades, with the goal of creating a healthier world for everyone. The company is dedicated to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead Sciences operates in more than 35 countries worldwide and is headquartered in Foster City, California, USA.