Everest Medicines Announces First Patient Dosed in its Phase 2b Registration Clinical Trial of Trodelvy™ (sacituzumab govitecan) for Metastatic Triple-Negative Breast Cancer in China
SHANGHAI, China, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the first patient has been dosed in China into the EVER-132-001 Phase 2b registration clinical trial evaluating Trodelvy^TM (sacituzumab govitecan, IMMU-132) for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.EVER-132-001 is a single-arm, multi-center Phase 2b registration clinical trial that is designed to evaluate the efficacy and safety of sacituzumab govitecan in Chinese patients with mTNBC who have received at least two prior systemic chemotherapy regimens. The primary endpoint of the trial will measure objective response rate (ORR) according to RECIST v 1.1 (a validated set of criteria to assess changes in tumor burden) by an Independent Review Committee. EVER-132-001 will enroll approximately 80 mTNBC patients in China in total.
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.
“TNBC accounts for 15 to 20% of all breast cancers and is known to be the most aggressive subgroup with a high risk of recurrence. The large patient population with mTNBC in China represents a huge unmet medical need where few therapies besides the standard cytotoxic chemotherapy are available,” said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. “Clinical data generated to date suggest that sacituzumab govitecan could enable a new standard of care for patients with pre-treated mTNBC.”
“Sacituzumab govitecan is an important advancement for patients as it is the first approved antibody drug conjugate (ADC) for mTNBC worldwide and the EVER-132-001 trial is an important first step towards fulfilling our promise to patients in China with mTNBC of a potential new treatment option that can meaningfully improve their lives,” said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. “We remain committed to working tirelessly to bring this potentially transformative medicine to all mTNBC patients in China.”
*About **S**acituzumab **G**ovitecan*
Sacituzumab govitecan is a first-in-class antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. Sacituzumab govitecan was granted accelerated approval by the U.S. FDA in April 2020 for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. In September 2020 at the ESMO 2020 annual conference, Immunomedics (now part of Gilead Sciences, Inc.) presented the confirmatory Phase III trial (ASCENT) demonstrating that sacituzumab govitecan significantly improved PFS and OS over standard single agent chemotherapy in pre-treated mTNBC patients with hazard ratio of 0.41 and 0.48, respectively. Under a licensing agreement with Immunomedics, 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.
*About Triple-Negative Breast Cancer *
Triple-Negative Breast Cancer (TNBC) is a highly aggressive disease and accounts for approximately 15%-20% of all breast cancer types worldwide.^i^-iii The median age of breast cancer diagnoses tends to be younger in China than western countries, and the percentage of 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.^iv^-viii
*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. For more information, please visit its website at www.everestmedicines.com.
*For further information, please contact:*
Everest Medicines
Media in US and Europe:
Darcie Robinson
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(203) 919-7905
darcie.robinson@icrinc.com
Media in China:
Edmond Lococo
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+86 (10) 6583-7510
edmond.lococo@icrinc.com
1. DeSantis CE, Fedewa SA, Goding Sauer A, Kramer JL, Smith RA, Jemal A. Breast cancer statistics, 2015: convergence of incidence rates between black and white women. CA Cancer J Clin 2016;66:31-42.
2. 4. Plasilova ML, Hayse B, Killelea BK, Horowitz NR, Chagpar AB, Lannin DR. Features of triple-negative breast cancer: analysis of 38,813 cases from the National Cancer Database. Medicine (Baltimore) 2016;95(35):e4614.
3. Kohler BA, Sherman RL, Howlader N, et al. Annual report to the nation on the status of cancer, 1975-2011, featuring incidence of breast cancer subtypes by race/ ethnicity, poverty, and state. J Natl Cancer Inst 2015;107(6):djv048.
4. Khosravi-Shahi P, Cabezón-Gutiérrez L, Custodio-Cabello S. Metastatic triple negative breast cancer: optimizing treatment options, new and emerging targeted therapies. Asia Pac J Clin Oncol 2018;14: 32-9.
5. Brufsky A, Valero V, Tiangco B, et al. Second-line bevacizumab-containing therapy in patients with triple-negative breast cancer: subgroup analysis of the RIBBON-2 trial. Breast Cancer Res Treat 2012;133: 1067-75.
6. Perez EA, Patel T, Moreno-Aspitia A. Efficacy of ixabepilone in ER/PR/HER2- negative (triple-negative) breast cancer. Breast Cancer Res Treat 2010;121:261-71.
7. Park IH, Im SA, Jung KH, et al. Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane: PROCEED trial (KCSG BR 11-01). Cancer Res Treat 2019; 51:43-52.
8. Twelves C, Awada A, Cortes J, et al. Subgroup analyses from a phase 3, openlabel, randomized study of eribulin mesylate versus capecitabine in pretreated patients with advanced or metastatic breast cancer. Breast Cancer (Auckl) 2016;10:77- 84.