MSD and Chinese partner Kelun-Biotech have announced that the Phase III TroFuse-005 trial of their TROP2-targeted antibody-drug conjugate (ADC), sacituzumab tirumotecan, met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with advanced or recurrent endometrial cancer. The study is the first late-stage trial to demonstrate a statistically significant improvement in both OS and PFS compared to chemotherapy in this patient population, which had previously received platinum-based chemotherapy and PD-1/L1 immunotherapy. The trial also met its key secondary endpoint of objective response rate (ORR).

The safety profile of sacituzumab tirumotecan was consistent with prior studies, with no new safety signals identified. Detailed data will be presented at a future medical conference. The positive outcome is the first from the extensive TroFuse clinical development program, which includes 17 ongoing global Phase III trials across multiple tumour types. The result supports the potential of sacituzumab tirumotecan to become a new standard of care in this difficult-to-treat setting.

PharmCube's NextBiopharm® database shows that sacituzumab tirumotecan has been approved in China for four oncology indications. Click here to request a free trial for NextBiopharm®.