In TroFuse-005, 776 patients were randomized to sacituzumab tirumotecan or physician's choice of doxorubicin or paclitaxel.
At a prespecified interim analysis after a median follow-up of 14 months, median overall survival was 19 months with sacituzumab tirumotecan and 12.1 months with chemotherapy, corresponding to a 32% reduction in risk of death.
Median progression-free survival was 7.2 months versus 3.9 months, corresponding to a 41% reduction in risk of progression or death.
Objective response rates were 35.1% versus 17.3%; median duration of response was 11.1 months versus 6.9 months.
Grade 3 or higher treatment-related adverse events occurred in 54.4% with sacituzumab tirumotecan and 41.4% with chemotherapy.
Guideline-Based Recommendations
Diagnosis
Management
In TroFuse-005, sacituzumab tirumotecan was compared with physician's choice of doxorubicin or paclitaxel.
The trial administered sacituzumab tirumotecan at 4 mg/kg on day 1 of each 2-week cycle.
Sacituzumab tirumotecan remains investigational; FDA Priority Review does not constitute approval.
Monitoring & Follow-up
The most common grade 3 or higher treatment-related events with sacituzumab tirumotecan were anemia (23.7%), neutropenia (20.1%), and oral mucositis or stomatitis (9.9%).
Risks
Treatment-related adverse events led to discontinuation in 3.1% of sacituzumab tirumotecan recipients and 4.9% of chemotherapy recipients.
Treatment-related adverse events were associated with 3 deaths (0.8%) in each group.
Merck reported no new safety signals.
Patient & Prescribing Data
The trial enrolled 776 patients with advanced or recurrent endometrial cancer. The FDA application seeks approval for adults previously treated with platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor, separately or in combination.
Sacituzumab tirumotecan was administered at 4 mg/kg on day 1 of each 2-week cycle in the trial. The FDA accepted its biologics license application for Priority Review, with a target action date of June 15, 2027; it is not approved and remains investigational.
Clinical Best Practices
Interpret the reported efficacy results in the context of the prespecified interim analysis and median follow-up of 14 months.
Distinguish FDA Priority Review from FDA approval; sacituzumab tirumotecan remains investigational.
This twice-monthly newsletter highlights recently published research where Dana-Farber faculty are listed as first or senior authors. The information is pulled from PubMed and this issue notes papers published from May 16 - 31.
Researchers found larger biological age gaps in more recent birth cohorts and observed associations with higher risk of several cancers diagnosed before age 55.
