TroFuse-005 trial evaluating Sacituzumab Tirumotecan met primary endpoints of OS and PFS in certain patients with advanced or recurrent Endometrial cancer

CAR-T Digest - August 2020

Weekly Digest - May 2026

18 May 2026: TroFuse-005 trial evaluating Sacituzumab Tirumotecan met primary endpoints of OS and PFS in certain patients with advanced or recurrent Endometrial cancer

Merck & Co. announced that the Phase 3 TroFuse-005 trial of Sacituzumab Tirumotecan met its primary endpoints of overall survival and progression-free survival in patients with advanced or recurrent endometrial cancer previously treated with platinum-based chemotherapy and anti-PD-1/L1 immunotherapy
The study marks the first global Phase 3 trial in this setting where a TROP2-directed ADC demonstrated statistically significant improvements in both OS and PFS compared with chemotherapy, highlighting sac-TMT’s potential to address a major unmet need in advanced endometrial cancer
At the pre-specified interim analysis, sac-TMT also achieved the key secondary endpoint of objective response rate, outperforming physician’s choice chemotherapy, including doxorubicin or paclitaxel, while maintaining a safety profile consistent with prior studies and no new safety signals observed
Investigators noted that patients progressing after platinum chemotherapy and immunotherapy currently have limited effective treatment options, and the positive TroFuse-005 results suggest sac-TMT could emerge as a new therapeutic option for this difficult-to-treat population
The milestone also represents the first positive Phase 3 outcome from Merck’s expansive TroFuse clinical development program, which includes 17 ongoing global Phase 3 trials evaluating sac-TMT across multiple tumor types and disease stages as both monotherapy and combination therapy