According to a retrospective real-world study, sacituzumab govitecan was safe and effective among patients with metastatic triple-negative breast cancer (TNBC).

These data were first presented at the 2025 Annual Miami Breast Cancer Conference.

Sacituzumab govitecan was approved by the FDA for the treatment of patients with unresectable locally advanced or metastatic TNBC in April 2021. The regulation also required that patients had received at least 2 prior systemic therapies, with at least 1 in the metastatic setting. The approval was based on results from the phase 3 ASCENT trial, comparing sacituzumab govitecan with chemotherapy among this patient population.

This observational cohort study included 381 patients with metastatic TNBC who had received sacituzumab govitecan between April 2020 and June 2023 from the Flatiron Health database. All patients were treated with sacituzumab govitecan in the second line or later, with 62% having had prior taxane therapy, 44% with prior PD-1/L1 therapy, and 7% with prior PARP inhibitors. At the time of data cutoff, there were 13% of patients who were still receiving sacituzumab govitecan.

With a median follow-up duration of 8.7 months, the median overall survival (OS) was 11.3 months. The 12-month OS rate was 47% and the 24-month OS rate was 19%. There were 27% of patients who experienced grade 3/4 neutropenia while on sacituzumab govitecan and 59% of patients who received granulocyte colony-stimulating factor (G-CSF). The median time from initiation on sacituzumab govitecan to the first administration of G-CSF was 12 days. Of the patients who received any G-CSF, 10% experienced grade 3/4 neutropenia vs 13% among those who did not receive G-CSF. Of patients who received only primary G-CSF, grade 3/4 neutropenia occurred in 4%.

Rita Nanda, MD, University Chicago Medicine, Illinois, and coauthors highlighted the importance of managing neutropenia with prophylactic G-CSF treatment for real-world use of sacituzumab govitecan.

The study authors concluded, “In this real-world study, sacituzumab govitecan demonstrated effectiveness and a manageable safety profile in patients treated in second line or later for metastatic TNBC, consistent with results from the phase 3 ASCENT study and other real-world evidence studies.”

Source:

Doherty K. Sacituzumab govitecan produces comparable real-world OS results, low rates of neutropenia in metastatic TNBC. OncLive. Published online: March 7, 2025. Accessed March 7, 2025. https://www.onclive.com/view/sacituzumab-govitecan-produces-comparable-real-world-os-results-low-rates-of-neutropenia-in-metastatic-tnbc