Sacituzumab govitecan in advanced triple-negative breast cancer

Results from the ASCENT-03 phase 3 trial, recently published on The New England Journal of Medicine, showed a significant clinical benefit with sacituzumab govitecan in advanced triple-negative breast cancer.

ASCENT-03 trial is a phase 3 international, open-label, randomized study that enrolled 558 patients with previously untreated, advanced triple-negative breast cancer who were not candidates for PD-1 or PD-L1 inhibitors owing to previous use or coexisting conditions. Patients were randomized to receive the antibody-drug conjugate sacituzumab govitecan or chemotherapy. Median progression-free survival was 9.7 months with sacituzumab govitecan and 6.9 months with chemotherapy; an objective response was confirmed in 48% and 46% of patients, respectively, and the median response duration was 12.2 months and 7.2 months, respectively. The incidence of adverse events of grade 3 or higher with sacituzumab govitecan was similar to that with chemotherapy, but adverse events were common. Sacituzumab govitecan is approved in multiple countries for the treatment of metastatic triple-negative breast cancer after at least two previous systemic therapies or at least one in the context of metastatic disease; as authors point out, «sacituzumab govitecan as a first-line treatment resulted in longer survival than chemotherapy in patients with metastatic triple-negative breast cancer who were not candidates for a PD-1 or PD-L1 inhibitor; without sacituzumab govitecan as an option, many such patients may not survive to receive further treatment. Together, data from this trial and the ASCENT-04 trial support the use of sacituzumab govitecan in treatment regimens for patients with previously untreated, locally advanced unresectable or metastatic triple-negative breast cancer».