ASCENT-03 Finds Sacituzumab Govitecan Extends PFS Over Chemotherapy in First-Line PD-L1–Negative TNBC
Presented at ESMO with a concurrent NEJM publication, the phase 3 data indicate a potential new first-line option for patients ineligible for immunotherapy pending mature survival results.
Overview
- The global randomized trial enrolled 558 patients and showed median progression-free survival of 9.7 months with sacituzumab govitecan versus 6.9 months with chemotherapy after 13.2 months of follow-up.
- Among responders, the median duration of response was longer with sacituzumab govitecan at 12.2 months compared with 7.2 months for chemotherapy.
- Approximately 99% of participants had PD-L1–negative tumors and were ineligible for immune checkpoint inhibitors, and chemotherapy served as the standard-of-care comparator.
- Investigators reported a safety profile consistent with prior experience and manageable with current guidelines, and overall survival data remain immature.
- The study was funded by Gilead Sciences, and separate ESMO results in PD-L1–positive disease showed sacituzumab govitecan plus pembrolizumab maintained quality of life and improved progression-free survival versus chemotherapy plus pembrolizumab.