Gilead Announces Clinical Trial Collaborations With Merck to Evaluate Trodelvy in Combination With KEYTRUDA in First-Line Metastatic Non-Small Cell Lung Cancer

Gilead Sciences, Inc. (Nasdaq: GILD) today announced it has entered into two clinical trial collaboration and supply agreements with Merck (known as MSD outside of the United States and Canada) to evaluate the combination of Gilead’s Trop-2 targeting antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in first-line metastatic non-small cell lung cancer (NSCLC). As part of the collaboration, Merck will sponsor a global Phase 3 clinical trial of Trodelvy in combination with KEYTRUDA as a first-line treatment for patients with metastatic NSCLC. Additionally, the companies recently established an agreement whereby Gilead will sponsor a Phase 2 signal-seeking study evaluating combinations that include pembrolizumab in first-line NSCLC.

“We’re excited to broaden our clinical collaborations with Merck to investigate Trodelvy in combination with KEYTRUDA in another cancer where there is tremendous need for novel combinations to help improve patient outcomes,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “This partnership builds on our ambition of providing alternatives to traditional chemotherapy with Trodelvy containing regimens across some of the most difficult-to-treat cancers.”

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 specifically 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 provide a new treatment option for a broader set of patients with first-line metastatic NSCLC.

The use of Trodelvy for the treatment of NSCLC is investigational, and the safety and efficacy for this use have not been established or approved by any regulatory agency globally. 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 certain prior therapies. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for additional Important Safety Information for Trodelvy.