Merck claims its first pivotal sacituzumab win

Merck & Co has made a huge investment in its Kelun-originated TROP2-targeting ADC sacituzumab tirumotecan, and now it’s claimed its first global phase 3 win. On Monday Merck said the Trofuse-005 trial, testing sac-TMT versus chemo in post-PD-(L)1 and platinum endometrial cancer, had met its primary endpoints of progression-free and overall survival. Full results will be presented at a medical meeting. Gilead’s rival anti-TROP2 ADC Trodelvy is some way behind in the same setting, with the Ascent-Gyn-01 trial set to complete in 2029. Merck, meanwhile, has 17 global pivotal sac-TMT trials ongoing, including Trofuse-033 in first-line endometrial cancer, although that isn’t due to finish until 2032. The next Merck-sponsored trial to read out, according to the company’s 2025 ASCO presentation, could be Trofuse-15, in third-line-plus gastroesophageal cancer. Merck received a US commissioner’s national priority voucher (CNPV) for sac-TMT in December, although it’s unclear what indication is covered; Merck has only said the CNPV was given to a phase 3 study set to yield data in 2027. Meanwhile, sac-TMT is already approved in China for breast cancer and relapsed NSCLC; Kelun also claimed victory late last year in first-line NSCLC, with a Keytruda combo in the Optitrop-Lung05 study.

Merck-sponsored sacituzumab tirumotecan phase 3 trials

Notes: *also includes NSCLC driven by mutations in ALK, ROS1, BRAF, NTRK, MET or RET; pMMR=mismatch repair proficient. Source: OncologyPipeline.