HMN 2026: How Progression-free survival is prolonged with sacituzumab govitecan plus pembrolizumab in triple-negative breast cancer

For patients with previously untreated, programmed death ligand 1 (PD-L1)-positive, locally advanced unresectable or metastatic triple-negative breast cancer (TNBC), sacituzumab govitecan plus pembrolizumab yields significantly longer progression-free survival than chemotherapy plus pembrolizumab, according to a study published in the Jan. 22 issue of the New England Journal of Medicine.

Sara M. Tolaney, M.D., from the Dana-Farber Cancer Institute and Harvard Medical School in Boston, and colleagues randomly assigned patients with previously untreated PD-L1-positive, locally advanced unresectable or metastatic TNBC to receive either sacituzumab govitecan plus pembrolizumab or chemotherapy plus pembrolizumab (221 and 222 patients, respectively).

The researchers found that the median progression-free survival was 11.2 and 7.8 months with sacituzumab govitecan plus pembrolizumab and chemotherapy plus pembrolizumab, respectively (hazard ratio for disease progression or death, 0.65). Data were immature for overall survival. The percentage of patients with an objective response was 60% and 53% for sacituzumab govitecan plus pembrolizumab and chemotherapy plus pembrolizumab, respectively; among those with a response, the median duration of response was 16.5 and 9.2 months, respectively.

Adverse events of grade 3 or higher occurred in 71% and 70% of patients receiving sacituzumab govitecan plus pembrolizumab and chemotherapy plus pembrolizumab, respectively; the incidence of treatment discontinuation due to adverse events was 12% and 31%, respectively.

“The findings from the ASCENT-04/KEYNOTE-D19 and ASCENT-03 trials support the use of sacituzumab govitecan as a potential backbone treatment option, with or without pembrolizumab, for patients with previously untreated, locally advanced unresectable or metastatic triple-negative breast cancer,” the authors write.

The study was funded by Gilead Sciences, the manufacturer of sacituzumab govitecan, and was conducted in collaboration with Merck Sharp & Dohme.

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