As reported in the Journal of Clinical Oncology by Alessandro D. Santin, MD, and colleagues, findings in the endometrial cancer cohort of the phase II multicohort TROPiCS-03 trial indicated activity of the Trop-2–directed antibody-drug conjugate sacituzumab govitecan-hziy in pretreated patients with advanced disease.
Alessandro D. Santin, MD
Study Details
In the multicenter trial, 41 patients enrolled between August 2021 and December 2022 received sacituzumab govitecan at 10 mg/kg on days 1 and 8 every 3 weeks until disease progression or unacceptable toxicity. The median number of prior therapies was three (range = 1–6); 85% of patients had received both chemotherapy and immune checkpoint inhibitor treatment. The primary outcome measure was objective response on investigator assessment.
Responses
Median follow-up was 5.8 months (range = 0.7–19.3 months). Objective responses (all partial) were observed in 9 of 41 patients (22%, 95% confidence interval [CI] = 11%–38%). Stable disease was observed in an additional 18 patients (44%). The clinical benefit rate (objective response or stable disease for ≥ 6 months) was 32% (95% CI = 18%–48%). Median duration of response was 8.8 months (95% CI = 2.8 months to not estimable). Median progression-free survival was 4.8 months (95% CI = 2.8–9.8 months).
An exploratory analysis in 39 patients showed that tumor Trop-2 protein was highly expressed in endometrial cancer and showed limited correlation with efficacy.
KEY POINTS
- Objective response was observed in 22% of patients.
- Median response duration was 8.8 months.
Adverse Events
The most common adverse events of any grade were diarrhea (56%), nausea (54%), and fatigue (51%). Grade ≥ 3 adverse events occurred in 80% of patients, most commonly neutropenia (in 32%), diarrhea (in 20%), febrile neutropenia (in 17%), anemia (in 15%), and hypokalemia (in 15%). Serious adverse events occurred in 49% of patients. Adverse events led to treatment discontinuation in 5%. No treatment-related deaths were reported.
The investigators concluded, “Findings from TROPiCS-03 showed encouraging efficacy of sacituzumab govitecan with a manageable toxicity profile in a heavily pretreated population with advanced endometrial cancer. Safety findings were consistent with the known sacituzumab govitecan safety profile.”
Dr. Santin, of Yale School of Medicine, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Gilead Sciences, Inc. For full disclosures of the study authors, visit ascopubs.org.
