Sacituzumab tirumotecan (sac-TMT), a TROP2-directed antibody-drug conjugate, significantly improved overall survival and progression-free survival versus physician’s choice chemotherapy in advanced or recurrent endometrial cancer after platinum-based and anti–PD-1/PD-L1 therapy, according to TroFuse-005.

An interim analysis showed sac-TMT achieving statistically significant and clinically meaningful gains in OS and PFS compared with doxorubicin or paclitaxel, and it also met the key secondary endpoint of objective response rate.

Merck and Kelun-Biotech reported positive phase 3 results for sac-TMT, with primary endpoints met and improvements in survival versus physician’s choice chemotherapy.

Data will be presented later and shared with regulatory authorities worldwide as MSD pursues approvals and global commercialization potential.

The sac-TMT program follows earlier TROP2-directed ADCs in the market, underscoring competitive pressure from Trodelvy and Datroway in the field.

Safety findings indicate sac-TMT’s safety profile is consistent with prior studies with no new safety signals observed.

Merck is strategically expanding sac-TMT as Keytruda’s exclusivity wanes, leveraging a growing oncology pipeline to offset potential revenue declines.

Merck received a Commissioner’s National Priority Voucher to accelerate FDA review of sac-TMT, potentially shortening development timelines.

Merck Research Laboratories developed sac-TMT and announced TroFuse-005 results in May 2026; additional data have been shared at prior conferences.

Dr. Dean Li highlighted the TroFuse program’s scope and sac-TMT’s design to maximize tumor payload delivery while limiting impact on healthy tissue.

Merck and Kelun have a broad sac-TMT program with 17 ongoing global phase 3 studies; results from lung and breast cancer trials are anticipated for presentation at ASCO.

The TroFuse program, with exclusive Merck rights outside Greater China, aims to evaluate sac-TMT across multiple cancers, including endometrial, bladder, breast, cervical, gastric, NSCLC, and ovarian cancers, in various settings and combinations with immunotherapies.