On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy) for patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-based chemotherapy and PD-1 or PD-L1 inhibitors.
TROPHY test
In the TROPHY test (IMMU-132-06;ClinicalTrials.gov Identifier: NCT03547973) Evaluated the efficacy and safety of sacituzumab govitecan-hziy. This is a single-arm, multicenter trial that recruited 112 patients previously treated with platinum-containing chemotherapy and PD-1 or PD-L1 inhibitors.Patients with advanced or metastatic urethral epithelial cancer. The patient received intravenous sacituzumab govitecan on the 1st and 8th days of the 21-day treatment cycle at a dose of 10 mg/kg.
The primary efficacy endpoints were objective response rate and duration of response, assessed independently using the criteria for response assessment in solid tumors, version 1.1. The confirmed objective response rate was 27.7% (95% confidence interval [CI] = 19.6%–36.9%), of which 5.4% were complete responses and 22.3% were partial responses. The median duration of response was 7.2 months (n = 31; 95% CI = 4.7–8.6; range = 1.4 to 13.7).
The most common adverse reactions (incidence > 25%) in patients treated with sacituzumab govitecan are neutropenia, nausea, diarrhea, fatigue, hair loss, anemia, vomiting, constipation, decreased appetite, rash, and abdominal pain.
On the first and eighth days of the 21-day treatment cycle, the recommended dose of sacituzumab govitecan is 10 mg/kg once a week until the disease progresses or unacceptable toxicity occurs.
