Merck has announced encouraging Phase 3 results for its investigational cancer therapy sacituzumab tirumotecan (sac-TMT), offering new hope for patients with advanced or recurrent endometrial cancer who have limited treatment options after standard therapies fail.
The company revealed that the global TroFuse-005 clinical trial successfully achieved its two primary goals, improving overall survival (OS) and progression-free survival (PFS), when compared with conventional chemotherapy in previously treated patients.
Sac-TMT is a TROP2-directed antibody-drug conjugate (ADC), a next-generation targeted therapy designed to deliver chemotherapy directly to cancer cells while reducing damage to healthy tissues. According to Merck, this is the first global Phase 3 study in endometrial cancer to demonstrate statistically significant improvement in both survival and disease progression outcomes using a TROP2 ADC.
The TroFuse-005 study enrolled 776 patients with advanced or recurrent endometrial carcinoma or carcinosarcoma who had already received platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy. Participants were randomized to receive either sac-TMT or physician’s choice chemotherapy, including doxorubicin or paclitaxel.
Researchers also reported that the trial met a key secondary endpoint related to objective response rate, indicating the therapy helped shrink tumors in a meaningful number of patients. Importantly, Merck said no unexpected safety concerns were identified during the study.
Dr. Domenica Lorusso, global lead investigator of the trial, noted that endometrial cancer remains one of the few cancers with rising incidence and mortality worldwide, highlighting the urgent need for more effective therapies for patients whose disease progresses after immunotherapy and chemotherapy.
The positive outcome marks the first successful pivotal Phase 3 result from Merck’s broader TroFuse development program, which currently includes 17 ongoing global Phase 3 studies evaluating sac-TMT across multiple cancers, including ovarian, cervical, lung, gastric, bladder, and breast cancers.
Industry analysts believe the strong trial data could strengthen Merck’s oncology pipeline as the company seeks future growth beyond its blockbuster immunotherapy portfolio. Regulatory discussions and detailed clinical data presentations are expected in upcoming medical conferences.
