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# Merck’s Sac-TMT Gets Win in Endometrial Cancer
- URL: https://www.fdaweb.com/mercks-sac-tmt-gets-win-in-endometrial-cancer/
- Published: 2026-05-18T12:00:00.000Z
- Updated: 2026-09-14T13:39:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161159

Merck is reporting that its Phase 3 TroFuse-005 trial evaluating the investigational antibody-drug conjugate sacituzumab tirumotecan (Sac-TMT) met its primary endpoints of overall survival and progression-free survival in certain patients with advanced or recurrent endometrial cancer. The company says sac-TMT became the first TROP2-directed antibody-drug conjugate to demonstrate statistically significant improvements in both overall survival and progression-free survival compared with chemotherapy in patients whose disease had progressed following platinum-based chemotherapy and anti-PD-1/L1 immunotherapy.

The global study compared sac-TMT against physician’s choice chemotherapy, consisting of doxorubicin or paclitaxel, in patients with advanced or recurrent endometrial carcinoma and carcinosarcoma. At a pre-specified interim analysis, the investigational therapy also met a key secondary endpoint of objective response rate, Merck says. The company did not disclose detailed efficacy data but said results would be presented at a future medical meeting and discussed with regulators worldwide.

No new safety signals were identified, and the drug’s safety profile was consistent with prior studies, the company adds.

Sac-TMT is being developed by Merck in collaboration with Kelun-Biotech. The therapy is designed to target TROP2, a protein overexpressed in many solid tumors, and deliver a topoisomerase I inhibitor payload directly to cancer cells.

Endometrial cancer is the most common cancer of the uterus, Merck says, adding that about 68,270 new cases and 14,450 deaths are expected in the U.S. in 2026.