Journal: The New England journal of medicine
This international phase 3 trial evaluated sacituzumab govitecan versus chemotherapy in patients with previously untreated, locally advanced or metastatic triple-negative breast cancer who were ineligible for PD-1/PD-L1 inhibitors.
Among 558 patients, sacituzumab govitecan significantly improved median progression-free survival compared to chemotherapy:
- Sacituzumab govitecan: 9.7 months
- Chemotherapy: 6.9 months (HR 0.62; P<0.001)
Objective response rates were similar between groups (48% vs. 46%), but the response duration was longer with sacituzumab govitecan (12.2 vs. 7.2 months).
Grade 3 or higher adverse events occurred at comparable rates (66% vs. 62%), with neutropenia being the most common.
Fewer patients discontinued sacituzumab govitecan due to adverse events compared to chemotherapy (4% vs. 12%).
The study supports sacituzumab govitecan as an effective treatment option for this patient population with manageable toxicity.