Gilead's Trodelvy Plus Keytruda Improves Progression-Free Survival in First-Line PD-L1+ Metastatic TNBC

Gilead Sciences Inc. announced the publication of full results from the Phase 3 ASCENT-04/KEYNOTE-D19 clinical trial in The New England Journal of Medicine. The study evaluated the efficacy and safety of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab) compared to Keytruda plus chemotherapy in patients with previously untreated, inoperable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10). The ASCENT-04/KEYNOTE-D19 trial met its primary endpoint, with the combination of Trodelvy and Keytruda showing a 35% reduced risk of disease progression or death compared to the control group (HR: 0.65; p<0.001). Median progression-free survival was 11.2 months for the Trodelvy plus Keytruda group versus 7.8 months for the Keytruda plus chemotherapy group. The results were previously presented at the 2025 ASCO Annual Congress and the 2025 European Society for Medical Oncology Congress. Gilead has submitted supplemental applications for this indication to the U.S. Food and Drug Administration and the European Medicines Agency.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Gilead Sciences Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260120151830) on January 21, 2026, and is solely responsible for the information contained therein.