Merck Drug Sac-TMT Meets Survival Goals in Endometrial Cancer Trial

Merck announced Monday that its investigational drug sacituzumab tirumotecan met its primary endpoints of overall survival and progression-free survival in patients with advanced or recurrent endometrial cancer. The TroFuse-005 trial is the first global Phase 3 study to show statistically significant survival improvement compared to chemotherapy in this patient group.

It is also the first antibody-drug conjugate to achieve this result for endometrial cancer in this setting.

The trial enrolled 776 patients whose disease had progressed after platinum chemotherapy and immunotherapy. Participants were randomly assigned to receive sac-TMT every two weeks or a physician-selected chemotherapy regimen that included doxorubicin or paclitaxel.

Patients knew which treatment they received. The study met response-rate benchmarks and showed side-effect profiles consistent with earlier trials of the same drug.

Researcher Perspectives Dr.

Brian Slomovitz, co-director of gynecologic oncology at Mount Sinai and a trial investigator, said the number of endometrial cancer cases and deaths continues to rise. He noted that better treatment options for recurrent disease remain an unmet need.

"Despite recent advances, patients whose disease progresses following treatment with platinum and immunotherapy are urgently in need of new options, and these findings show for the first time that a TROP2 ADC may be an effective option in this setting," Slomovitz said.

Merck stated it will present full data, including survival benefit and toxicity details, at an upcoming medical meeting.