Gilead Announces Positive Phase III ASCENT-03 Trial Results: Trodelvy Shows Significant PFS Benefit in First-Line mTNBC Patients Ineligible for Immunotherapy

China Finance Network, October 19 — Gilead Sciences, Inc. (NASDAQ: GILD) today announced positive results from the Phase III ASCENT-03 study showing that Trodelvy (sacituzumab govitecan) as a first-line treatment for patients with metastatic triple-negative breast cancer (mTNBC) who are unsuitable for PD-1/PD-L1 inhibitor therapy significantly improved progression-free survival (PFS) compared to chemotherapy, with high statistical significance and clinical importance.

The study results were presented at the late-breaking oral abstract session (#LBA20) of the 2025 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine (NEJM).

The ASCENT-03 study successfully met its primary endpoint of PFS, demonstrating that, compared with chemotherapy, Trodelvy reduced the risk of disease progression or death by 38% (HR: 0.62; p<0.0001). The median PFS was 9.7 months in the Trodelvy group and 6.9 months in the chemotherapy group. The PFS benefit of Trodelvy over chemotherapy was consistent across all predefined subgroups, including patients with a poorer prognosis (such as those who relapsed within one year after radical treatment) and different chemotherapy regimen choices.

"For patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy, they face a very poor prognosis, limited treatment options, and rapid disease progression," said Dr. Javier Cortés, head of the International Breast Cancer Center in Spain and principal investigator of the ASCENT-03 study. The ability of sacituzumab govitecan to significantly delay disease progression and death may represent the first major treatment breakthrough for this patient population since the classification of triple-negative breast cancer was established 20 years ago, marking a historic shift and potentially establishing a new standard of care.

The objective response rate (ORR) was 48% in the Trodelvy group and 46% in the chemotherapy group. The median duration of response (DOR) was significantly longer in the Trodelvy group. Among patients who achieved confirmed complete or partial response, the DOR was 12.2 months in the Trodelvy group and 7.2 months in the chemotherapy group.

At the time of the primary PFS analysis, the overall survival (OS) data were not yet mature. Gilead Sciences will continue to follow up on the OS results of the patients and plans to conduct further analyses.

These results complement the recently published ASCENT-04/KEYNOTE-D19 studies, which showed that in first-line treatment of PD-L1 positive metastatic triple-negative breast cancer patients, Trodelvy (sacituzumab govitecan) combined with Keytruda (pembrolizumab) significantly improved PFS. Gilead Sciences is currently communicating data from these two studies with the U.S. Food and Drug Administration (FDA) and other global regulatory authorities.

"ASCENT-03 is the second Phase III study confirming that the Trodelvy-based regimen significantly outperforms chemotherapy in progression-free survival as a first-line treatment for metastatic triple-negative breast cancer, highlighting its potential to improve outcomes in patients with limited treatment options," said Dr. Dietmar Berger, Chief Medical Officer of Gilead Sciences. "With these potentially practice-changing results, Trodelvy is poised to redefine the first-line treatment landscape for metastatic triple-negative breast cancer, offering patients a much-needed alternative to chemotherapy."