Sac-TMT Phase 3 TroFuse-005 meets overall and progression-free survival endpoints in endometrial cancer

Merck said its Phase 3 TroFuse-005 trial of sacituzumab tirumotecan (sac-TMT) met both primary endpoints, overall survival and progression-free survival, versus physician's choice chemotherapy in advanced or recurrent endometrial cancer patients who had already received platinum chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The result came from a prespecified interim analysis of 776 randomized patients, and the key secondary endpoint of objective response rate was also met. It is the first Phase 3 readout from Merck's broader sac-TMT program, so the drug moves closer to a filing.

• 776 patients randomized; prespecified interim analysis
• Overall survival and progression-free survival both statistically significant
• Key secondary endpoint, objective response rate, also met
• No new safety signals reported