Response rate of 33.3 percent, median response duration of 7.7 months observed in 108 patients
THURSDAY, Feb. 21, 2019 (HealthDay News) — An antibody-drug conjugate, sacituzumab govitecan-hziy, shows promise in refractory metastatic triple-negative breast cancer, according to a study published in the Feb. 21 issue of the New England Journal of Medicine.
Aditya Bardia, M.D., from the Massachusetts General Hospital Cancer Center in Boston, and colleagues conducted a phase 1/2 multicenter trial involving patients with advanced epithelial cancers who received sacituzumab govitecan-hziy intravenously on days 1 and 8 of each 21-day cycle. A total of 108 patients received sacituzumab govitecan-hziy after receiving at least two previous anticancer therapies for metastatic triple-negative breast cancer (median of three previous therapies).
The researchers noted that there were four deaths during treatment and that three patients discontinued treatment because of adverse events. Grade 3 or 4 adverse events occurred in ≥10 percent of the patients and included anemia and neutropenia; 9.3 percent had febrile neutropenia. The response rate was 33.3 percent, with three complete and 33 partial responses; the median response duration was 7.7 months. These values were 34.3 percent and 9.1 months as assessed by independent central review. The rate of clinical benefit was 45.4 percent. Median progression-free survival and overall survival were 5.5 and 13 months, respectively.
“Our results suggest that sacituzumab govitecan is an active agent against metastatic triple-negative breast cancer that is not cross resistant with other treatments and has a manageable safety profile, thus representing a potential novel therapeutic paradigm,” Bardia said in a statement.
The study was funded by Immunomedics, which developed sacituzumab govitecan.
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