Everest Medicines announced 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). 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. 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.

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%.