To compare sacituzumab tirumotecan with physician’s-choice chemotherapy in previously treated advanced or recurrent endometrial cancer.
Approach:
Design: TroFuse-005 was a randomized, open-label, multicenter phase 3 trial involving 776 patients.
Treatments and outcomes: Patients received sacituzumab tirumotecan or doxorubicin or paclitaxel. Dual primary endpoints were overall survival and progression-free survival.
Key Findings:
At a prespecified interim analysis after a median 14-month follow-up, median overall survival was 19 months with sacituzumab tirumotecan and 12.1 months with chemotherapy, corresponding to a 32% lower risk of death.
Median progression-free survival was 7.2 months versus 3.9 months, corresponding to a 41% lower risk of progression or death.
Objective response rates were 35.1% and 17.3%; median duration of response was 11.1 months and 6.9 months, respectively.
Grade 3 or higher treatment-related adverse events occurred in 54.4% of patients receiving sacituzumab tirumotecan and 41.4% receiving chemotherapy. Treatment-related adverse events led to discontinuation in 3.1% and 4.9%, respectively.
Interpretation:
The trial reported longer median overall and progression-free survival with sacituzumab tirumotecan than with chemotherapy. The drug remains investigational; FDA Priority Review is not approval.
Limitations:
The reported results are from a prespecified interim analysis.
The context does not provide confidence intervals or additional statistical details.
Conclusion:
The FDA accepted a biologics license application for Priority Review, with a target action date of June 15, 2027.
