Endometrial cancer drug cuts progression or death risk 41%

FDA grants Priority Review to following improved survival versus chemotherapy in phase 3 trial.

By
Mouj Hijazi
October 27, 2026
3 min

MDSpire News

Overview

In the phase 3 TroFuse-005 trial, investigational sacituzumab tirumotecan (sac-TMT) improved median progression-free and overall survival compared with physician’s-choice chemotherapy in previously treated advanced or recurrent endometrial cancer. The FDA accepted a biologics license application for Priority Review; the drug remains investigational and is not FDA-approved for this indication.

Background

Advanced or recurrent endometrial cancer has been studied in trials of chemotherapy, immunotherapy, and targeted combinations. Related phase 3 studies have evaluated checkpoint inhibitors with chemotherapy in the first-line setting, including durvalumab in DUO-E and dostarlimab-based treatment. In the United States, the FDA approved pembrolizumab with carboplatin and paclitaxel, followed by pembrolizumab maintenance, for primary advanced or recurrent endometrial carcinoma in June 2024. Sac-TMT is being evaluated after prior platinum-containing chemotherapy and PD-1 or PD-L1 inhibitor treatment.

Data Highlights

Outcome	Sac-TMT	Chemotherapy
Patients enrolled	776 total in trial	776 total in trial
Median overall survival	19 months	12.1 months
Risk reduction in death	32%	—
Median progression-free survival	7.2 months	3.9 months
Risk reduction in progression or death	41%	—
Objective response rate	35.1%	17.3%
Complete response rate	6.1%	4.5%
Median duration of response	11.1 months	6.9 months
Grade 3 or higher treatment-related adverse events	54.4%	41.4%
Treatment-related adverse events leading to discontinuation	3.1%	4.9%
Treatment-related deaths	3 (0.8%)	3 (0.8%)

Key Findings

TroFuse-005 was a randomized, open-label, multicenter phase 3 trial of 776 patients with advanced or recurrent endometrial cancer; participants received sac-TMT 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 sac-TMT and 12.1 months with chemotherapy, corresponding to a 32% reduction in risk of death.
Median progression-free survival, assessed by blinded independent central review, was 7.2 months with sac-TMT versus 3.9 months with chemotherapy, corresponding to a 41% reduction in risk of progression or death.
Objective response rates were 35.1% and 17.3%, respectively; median duration of response was 11.1 months with sac-TMT and 6.9 months with chemotherapy.
Grade 3 or higher treatment-related adverse events occurred in 54.4% of sac-TMT recipients and 41.4% of chemotherapy recipients. The most common severe events with sac-TMT were anemia (23.7%), neutropenia (20.1%), and oral mucositis or stomatitis (9.9%).
The FDA accepted the sac-TMT biologics license application for Priority Review, with a target action date of June 15, 2027; Priority Review is not approval, and sac-TMT remains investigational.

Clinical Implications

The reported results concern patients with advanced or recurrent endometrial cancer previously treated with platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor, the population specified in the application. Sac-TMT is not currently approved for this indication; the trial also reported a higher rate of grade 3 or higher treatment-related adverse events than chemotherapy.

Conclusion

In TroFuse-005, sac-TMT was associated with longer median overall and progression-free survival than physician’s-choice chemotherapy, alongside more grade 3 or higher treatment-related adverse events. Regulatory review is ongoing.