Merck & Co. announced detailed results from the randomized Phase III TroFuse-005 trial evaluating sacituzumab tirumotecan, or sac-TMT, a TROP2-directed antibody-drug conjugate developed in collaboration with Kelun-Biotech.
Among 776 patients with advanced or recurrent endometrial cancer previously treated with platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy, median overall survival was 19.0 months versus 12.1 months with chemotherapy (HR 0.68; 95% CI 0.55–0.84; p<0.0001).
Median progression-free survival was 7.2 versus 3.9 months (HR 0.59), while Grade 3 or higher treatment-related adverse events occurred in 54.4% of sac-TMT recipients versus 41.4% of controls.
The FDA has accepted the biologics license application for priority review, with a target action date of June 15, 2027. This is a review decision, not marketing approval. Merck.com
Primary source: Merck — TroFuse-005 Phase III Results, October 26
Why it matters strategically
The results establish an overall survival advantage against physician-selected chemotherapy in the studied population.
This is clinically important because the trial evaluates patients who have already received major established treatment classes.
However, the strategic significance extends beyond one indication.
Merck is conducting 18 ongoing global Phase III trials involving sac-TMT across multiple cancer types.
The program therefore represents a substantial clinical-development commitment.
Positive evidence in one indication may strengthen confidence in the asset's broader potential, but it does not establish efficacy across other tumor types or treatment settings.
