ASCENT-04 Trial: First-Line Sacituzumab Govitecan Plus Pembrolizumab Improves PFS in PD-L1+ TNBC
Key Points
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ASCENT-04 trial data support sacituzumab govitecan plus pembrolizumab as a potential new standard of care for previously untreated, PD-L1–positive, advanced triple-negative breast cancer (TNBC).
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Despite promising results, disease recurrence remains an issue.
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Global inequities for advanced TNBC treatment present a challenge.
Data from the ASCENT-04/KEYNOTE-D19 trial showed that frontline sacituzumab govitecan plus pembrolizumab significantly improved progression-free survival (PFS) for patients with PD-L1–positive, advanced or metastatic TNBC compared with chemotherapy plus pembrolizumab.
The phase 3 study included 443 patients and reported the longest PFS to date in the first-line metastatic setting, according to Hope Rugo, MD, FASCO, of City of Hope Comprehensive Cancer Center. Dr. Rugo offered her insights on the study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
In an interview with Arya Mariam Roy, MD, of The Ohio State University Comprehensive Cancer Center, Dr. Rugo discussed the significance of the trial findings and how it applies to real-world treatment.
Although the results are promising, some patients still face disease recurrence. Dr. Rugo delved into the effectiveness of the ASCENT-04/KEYNOTE-D19 regimen in this patient population, as well as the adverse event profile of the treatment.
In the United States, patients have better access to novel therapies compared with patients throughout the world. Dr. Rugo talked about global inequities and how trials should be designed to equalize access to care.