Drugmaker Merck announced that the investigational drug sacituzumab tirumotecan (sac-TMT) met its primary endpoints of overall survival and progression-free survival in patients with advanced or recurrent endometrial cancer. The TroFuse-005 trial marks the first global Phase 3 trial to demonstrate statistically significant improvement in survival compared to chemotherapy in these patients, and represents the first and only antibody-drug conjugate (ADC) to achieve such a result for endometrial cancer in this setting.
The trial involved 776 patients with endometrial cancer whose disease worsened after receiving both platinum chemotherapy and immunotherapy. Patients were randomly assigned to receive sac-TMT, administered every two weeks, or a treatment of the physician’s choice, including doxorubicin or paclitaxel chemotherapy. Those receiving sac-TMT showed clinically meaningful improvement in their disease state compared to the treatment of physician’s choice. The study also met response rate benchmarks and exhibited similar side effects to earlier studies of the drug. Merck noted the researchers plan to present full Phase 3 data at an upcoming medical meeting.
Addressing an Unmet Need
Dr. Domenica Lorusso, the study’s global lead investigator and professor of obstetrics and gynecology at Humanitas University and Humanitas San Pio X in Milan, stated that sac-TMT “may be able to address a critical unmet need for certain patients with advanced endometrial cancer, one of the only cancers increasing in both incidence and mortality worldwide.” She added that despite recent advances, patients whose disease progresses following platinum and immunotherapy treatment “are urgently in need of new options,” and the findings show for the first time that a TROP2 ADC may be an effective option.
Dr. Brian Slomovitz, co-director of gynecologic oncology at Mount Sinai and an investigator on the trial, emphasized the significance of the finding. He noted that endometrial cancer and death rates are on the rise, and in the United States, deaths from endometrial cancer have surpassed deaths from ovarian cancer, making it the deadliest of all gynecologic malignancies. While immunotherapy has become standard care, “better treatment options” for patients with recurrent disease “remains an unmet need,” he noted. If the full data confirm the announcement, he emphasized that overall survival improvement in recurrent disease represents “a real, meaningful result for patients and their families, not just a statistical one.”
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://newspub.live/health/new-drug-approach-offers-hope-for-patients-with-recurrent-aggressive-cancers/