Merck’s sac-TMT gains FDA priority review as endometrial-cancer survival data emerge

Merck ($MRK) disclosed detailed results from the global Phase 3 TroFuse-005 trial and said the FDA accepted sacituzumab tirumotecan for priority review. In 776 patients with advanced or recurrent endometrial cancer previously treated with platinum chemotherapy and immunotherapy, median overall survival reached 19.0 months versus 12.1 months with chemotherapy. The hazard of death fell 32%; median progression-free survival was 7.2 versus 3.9 months.

The experimental drug, developed with Kelun-Biotech, now has a June 15, 2027 FDA action date. That is a review timetable, not approval. Grade 3 or worse treatment-related adverse events affected 54.4% of recipients versus 41.4% of controls; treatment-related deaths occurred in three patients in each group. These first detailed global endometrial results and the regulatory advance are separate from previously reported Chinese lung-cancer studies.

Sources:

• Merck — clinical results