Gilead Publication of Phase 3 Trial Results of Trodelvy and Keytruda for Breast Cancer

 New England Journal of Medicine Publishes Phase 3 ASCENT-04/KEYNOTE-D19 Results Supporting Trodelvy® Plus Keytruda® as a Potential New Standard of Care in First-line PD-L1+ Metastatic Triple-negative Breast Cancer

– Combination Reduced the Risk of Death or Disease Progression by 35% Versus Standard of Care in Frontline PD-L1+ Metastatic TNBC Setting –

Gilead Sciences, Inc. (Nasdaq: GILD) today announced The New England Journal of Medicine(NEJM) published the full results from the positive Phase 3 ASCENT-04/KEYNOTE-D19 study evaluating the combination of Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) in first-line PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer (TNBC). ASCENT-04 successfully met its primary endpoint of progression-free survival (PFS) with a 35% (HR: 0.65; p<0.001) reduced risk of disease progression or death for Trodelvy plus Keytruda (n=221) versus standard of care Keytruda plus chemotherapy (n=222). Median PFS with Trodelvy plus Keytruda was 11.2 months versus 7.8 months when Keytruda was given in combination with chemotherapy.

“Metastatic TNBC patients often show rapid progression and poor outcomes after current first-line therapies, illustrating the urgent need for new and more efficacious treatment options,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “These results represent important progress toward our goal of delivering Trodelvy to patients in earlier lines of breast cancer treatment, with potential to become a backbone therapy for all frontline metastatic TNBC patients in need of innovative therapeutics.”

“Patients with PD-L1+ metastatic triple-negative breast cancer continue to face limited options in the first-line setting,” said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and Principal Investigator of the ASCENT-04 study. “As such, these very promising data with the novel combination of sacituzumab govitecan and pembrolizumab in frontline metastatic TNBC represent a meaningful step forward in establishing a potential new standard of care for this challenging disease.”

The NEJM publication of the ASCENT-04 results follow a data presentation at the 2025 ASCO Annual Congress, as well a simultaneous presentation at the 2025 European Society for Medical Oncology Congress and publication in NEJMof primary results from the ASCENT-03 trial of Trodelvy monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors. Gilead has submitted supplemental applications for both indications to the U.S. Food and Drug Administration and European Medicines Agency.

https://www.morningstar.com/news/business-wire/20260120151830/new-england-journal-of-medicine-publishes-phase-3-ascent-04keynote-d19-results-supporting-trodelvy-plus-keytruda-as-a-potential-new-standard-of-care-in-first-line-pd-l1-metastatic-triple-negative-breast-cancer