Multinational phase 3 trial of sacituzumab govitecan plus pembrolizumab for advanced triple-negative breast cancer

The multinational phase 3 ASCENT-04/KEYNOTE-D19 trial evaluated sacituzumab govitecan (SG) plus pembrolizumab in patients with previously untreated, PD-L1 positive, locally advanced unresectable or metastatic triple-negative breast cancer (TNBC). A total of 443 patients were randomized to SG plus pembrolizumab (n=221) or chemotherapy plus pembrolizumab (n=222). The primary endpoint was progression-free survival (PFS) as assessed by blinded independent central review. Median PFS was 11.2 months with SG plus pembrolizumab and 7.8 months with chemotherapy plus pembrolizumab (HR 0.65; p<0.001). Data for overall survival were immature. Percentage of patients with an objective response was 60% with SG plus pembrolizumab and 53% with chemotherapy plus pembrolizumab; among patients with a response, the median duration of response was 16.5 months and 9.2 monts, respectively. Adverse events of grade 3 or higher occurred in 71% of the patients receiving SG plus pembrolizumab and in 70% of those receiving chemotherapy plus pembrolizumab, with incidence of treatment discontinuation due to adverse events 12% and 31%, respectively. Adverse events leading to death occurred in 3% of patients in each group. The authors conclude that SG plus pembrolizumab led to longer PFS than chemotherapy plus pembrolizumab among patients with previously untreated, PD-L1 advanced TNBC (quick take video summary).