Merck’s Sac-TMT met primary endpoints in endometrial cancer trial

Merck (MRK) announced the pivotal Phase 3 TroFuse-005 trial evaluating sacituzumab tirumotecan, or sac-TMT, an investigational TROP2-directed antibody-drug conjugate, or ADC, being developed in collaboration with Kelun-Biotech, met its primary endpoints of overall survival – OS – and progression-free survival – PFS – in certain patients with advanced or recurrent endometrial cancer. TroFuse-005 is the first global Phase 3 trial to demonstrate statistically significant improvement in both OS and PFS compared to chemotherapy for these patients and the first and only ADC to do so for patients with endometrial cancer in this setting. Sac-TMT demonstrated a statistically significant and clinically meaningful improvement in OS and PFS compared to treatment of physician’s choice for patients with endometrial cancer who have previously received platinum-based chemotherapy and anti-PD-1/L1 immunotherapy either together or separately. The study also reached its key secondary endpoint of objective response rate. These data will be presented at an upcoming medical meeting and discussed with regulatory authorities worldwide. The safety profile was consistent with what has been observed in previously reported studies of sac-TMT; no new safety signals were observed. TroFuse-005 also marks the first positive Phase 3 results from Merck’s TroFuse clinical development program for sac-TMT. The program currently consists of 17 ongoing global Phase 3 trials across multiple tumor types.