October 19, 2025 — Foster City, Calif. — Leads & Copy — Gilead Sciences, Inc. (Nasdaq: GILD) has announced positive data from its Phase 3 ASCENT-03 study, revealing a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) for Trodelvy® (sacituzumab govitecan-hziy) compared to chemotherapy as a first-line treatment for metastatic triple-negative breast cancer (TNBC) patients who are not candidates for PD-1/PD-L1 inhibitors. The findings were presented at the 2025 European Society for Medical Oncology (ESMO) Congress and published in The New England Journal of Medicine.
The ASCENT-03 study met its primary endpoint, demonstrating a 38% reduction in the risk of disease progression or death with Trodelvy versus chemotherapy (HR: 0.62; p<0.0001). The median PFS with Trodelvy was 9.7 months compared to 6.9 months with chemotherapy. Results were consistent across subgroups, including those with poorer prognoses.
Dr. Javier Cortés, Head of the International Breast Cancer Center in Spain and principal investigator, noted that sacituzumab govitecan could represent the first major treatment advance in 20 years for metastatic TNBC patients ineligible for immunotherapy.
The objective response rate (ORR) was 48% with Trodelvy and 46% with chemotherapy, with a longer median duration of response (DOR) of 12.2 months for Trodelvy compared to 7.2 months for chemotherapy.
Overall survival (OS) data is still being monitored. Gilead is engaging with the FDA and other global regulators regarding the ASCENT-03 data and the recent ASCENT-04/KEYNOTE-D19 results, which showed a significant PFS benefit for Trodelvy plus Keytruda® (pembrolizumab) in PD-L1+ first-line metastatic TNBC.
Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences, stated that Trodelvy is poised to transform the first-line metastatic TNBC treatment landscape, offering an alternative to chemotherapy.
The safety profile of Trodelvy in the ASCENT-03 study was consistent with prior studies. Trodelvy has treated over 60,000 breast cancer patients across 50+ countries over the past five years.
U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
Source: Gilead Sciences, Inc.
