Bardia A, et al. - Given that sacituzumab govitecan-hziy enables delivery of high concentrations of SN-38 to tumors, researchers examined the safety and efficacy of providing sacituzumab govitecan-hziy to patients with advanced epithelial cancers. Outcomes revealed durable objective responses in patients with heavily pretreated metastatic triple-negative breast cancer in correlation with sacituzumab govitecan-hziy. The main adverse reactions comprised myelotoxic effects.

Methods

• A phase 1/2 single-group, multicenter trial was performed including patients with advanced epithelial cancers; sacituzumab govitecan-hziy was given to the patients intravenously on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxic effects.
• Sacituzumab govitecan-hziy was administered to a total of 108 patients at a dose of 10 mg per kilogram of body weight; these patients had reported reception of at least two previous anticancer therapies for metastatic triple-negative breast cancer.
• For this trial, the end points were: safety; the objective response rate (according to Response Evaluation Criteria in Solid Tumors, version 1.1), which was assessed locally; the duration of response; the clinical benefit rate (defined as a complete or partial response or stable disease for at least 6 months); progression-free survival; and overall survival.
• Blinded independent central review assessed the response rate and duration using post hoc analyses.

Results

• Reception of a median of 3 previous therapies (range, 2 to 10) was reported in 108 patients with triple-negative breast cancer.
• Death of 4 patients was reported during treatment; treatment discontinuation was noted in 3 patients (2.8%) because of adverse events.
• Anemia and neutropenia comprised grade 3 or 4 adverse events (in ≥10% of the patients); febrile neutropenia was noted in 10 patients (9.3%).
• They noted response rate (3 complete and 33 partial responses) of 33.3% (95% confidence interval [CI], 24.6 to 43.1) and the median duration of response of 7.7 months (95% CI, 4.9 to 10.8); the respective values were 34.3% and 9.1 months as per independent central review.
• The clinical benefit rate of 45.4% was observed.
• Median progression-free survival and overall survival were 5.5 months (95% CI, 4.1 to 6.3) and 13.0 months (95% CI, 11.2 to 13.7), repectively.