MSD says sac-TMT met primary endpoints in Phase III endometrial cancer trial

MSD said sacituzumab tirumotecan (sac-TMT) demonstrated a statistically significant and clinically meaningful improvement in overall survival and progression-free survival in the Phase III TroFuse-005 trial in patients with endometrial cancer. The study compared sac-TMT with treatment of the physician’s choice, consisting of doxorubicin or paclitaxel, in patients who have previously received platinum-based chemotherapy and anti-PD-1/L1 immunotherapy either together or separately.

The study also reached its key secondary endpoint of objective response rate. The trial enrolled 776 patients who were randomised to receive either sac-TMT or treatment of the physician’s choice.

MSD said TroFuse-005 is the first global Phase III trial to demonstrate statistically significant improvement in both overall survival and progression-free survival compared to chemotherapy for these patients and the first and only antibody-drug conjugate to do so for patients with endometrial cancer in this setting. The safety profile was consistent with what has been observed in previously reported studies of sac-TMT, with no new safety signals observed.

These data will be presented at an upcoming medical meeting and discussed with regulatory authorities worldwide. MSD’s TroFuse clinical development programme for sac-TMT consists of 17 ongoing global Phase III trials across multiple tumour types, including 10 Phase III trials in women’s cancers.

Sac-TMT, which is being developed in collaboration with Kelun-Biotech, acts by targeting the trophoblast cell surface antigen-2 (TROP2) protein, which is widely expressed across a variety of solid tumours and is often associated with poor patient prognosis. The drug is already approved in China in multiple cancer indications.