On January 10, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), reported it will participate in a study pursuant to a clinical trial collaboration between Gilead and MSD (Merck & Co., Inc., Kenilworth, NJ., USA) to evaluate the combination of the Trop-2 targeting antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) and MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in first-line metastatic non-small cell lung cancer (NSCLC) (Press release, Everest Medicines, JAN 10, 2022, View Source [SID1234598550]). As part of the collaboration, MSD will sponsor a global Phase 3 clinical trial of Trodelvy in combination with KEYTRUDA as a first-line treatment for patients with metastatic NSCLC. Everest Medicines will participate in the global Phase 3 study in Asia through its existing collaboration agreement with Gilead.
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"We look forward to participating in a study pursuant to a clinical collaboration between Gilead and MSD to evaluate Trodelvy in combination with KEYTRUDA in first-line NSCLC patients," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines.
NSCLC is the most common type of lung cancer and accounts for up to 85% of cases. It is an aggressive disease with poor prognosis. Although there has been significant progress in recent years in the treatment of the disease, there is a still a major unmet need for patients with only 25% of patients surviving beyond five years.
Trodelvy is an antibody-drug conjugate that targets Trop-2 expressing cells to enable local delivery of a cytotoxic payload that selectively kills the targeted cells. The combination of Trodelvy with an immune-stimulating agent such as KEYTRUDA could potentially provide a new treatment option for a broader set of patients with first-line metastatic NSCLC.
In the United States, Trodelvy is approved for the treatment of second-line metastatic triple-negative breast cancer (TNBC), and has additionally been approved under the accelerated approval pathway for the treatment of metastatic urothelial cancer (UC) in adults who have received prior therapy. Everest is closely coordinating with regulatory bodies in Greater China, Singapore and South Korea to review its applications for SG 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. The use of Trodelvy for the treatment of NSCLC is investigational, and this use has not been approved by any regulatory agency globally.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer (including both NSCLC and small-cell lung cancer (SCLC)) is the second most common cancer in both men and women and is the leading cause of cancer death, making up approximately 25% of all cancer deaths. NSCLC is the most common type of lung cancer and accounts for up to 85% of cases. It is an aggressive disease with poor prognosis, and the relative five-year survival rate is 25%.
About Sacituzumab Govitecan
Sacituzumab govitecan (SG) 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. SG is approved for adults with second-line metastatic TNBC in the United States, the European Union, Australia, Canada, Great Britain and Switzerland under the trade name Trodelvy. Review is also underway in Greater China, South Korea and Singapore through Everest Medicines. Trodelvy is also approved under the accelerated approval pathway 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 SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG 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.