Sacituzumab govitecan plus pembrolizumab in triple-negative breast cancer

In a phase 3 trial, recently published on The New England Journal of Medicine, sacituzumab govitecan in association with pembrolizumab led to significantly longer progression-free survival in patients with  previously untreated advanced triple-negative breast cancer.

In this open-label international phase 3 ASCENTE04/KEYNOTE19 trial a total of 443 patients with PD-L1 positive, locally advanced unresectable or metastatic triple-negative breast cancer were randomly assigned to receive sacituzumab govitecan plus pembrolizumab of chemotherapy plus pembrolizumab. Median progression-free survival was 11.2 months with sacituzumab govitecan plus pembrolizumab and 7.8 months with chemotherapy plus pembrolizumab, with an objective response of 60% and 53% respectively; among these patients, median duration of response was 16.5 and 9.2 months respectively. Overall survival data were immature, and adverse events rate were similar, with an incidence of treatment discontinuation due to adverse events of 12% with sacituzumab govitecan plus pembrolizumab and 31% with chemotherapy plus pembrolizumab. Updated results from the trial, presented at ASCO 2026, show show that the benefit of sacituzumab govitecan plus pembrolizumab persisted beyond first disease progression with improvement in progression-free survival 2 (an emerging endpoint more closely associated with overall survival) and median time to first subsequent treatment. As authors said at ASCO, «This suggests that the benefit of giving pembrolizumab plus sacituzumab govitecan as first-line therapy over chemotherapy is sustained in the long term, further supporting this combination as a potential new standard of care».