Merck's sacituzumab tirumotecan global Phase III shows longer PFS and OS; FDA grants priority review

Merck reported the global Phase III TroFuse-005/ENGOT-en23/GOG-3095 trial of sacituzumab tirumotecan in endometrial cancer patients previously treated with platinum chemotherapy and anti-PD-(L)1 therapy, where both PFS and OS beat chemotherapy. The study enrolled 776 patients: PFS was 7.2 vs 3.9 months (HR=0.59, P<0.0001), OS was 19.0 vs 12.1 months (HR=0.68, P=0.0001), and ORR was 35.1% vs 17.3%. The US marketing application has been accepted by FDA with priority review.