A new treatment for endometrial cancer showed promise in a Phase 3 clinical trial. Merck announced that the investigational drug sacituzumab tirumotecan (sac-TMT) achieved its primary goals of improving overall survival and progression-free survival in patients with advanced or recurrent endometrial cancer.
The TroFuse-005 trial is the first global Phase 3 trial to achieve statistically significant survival improvement over chemotherapy in these patients, as per a Merck press release. Remarkably, it is the first and only antibody-drug conjugate (ADC) to do so for endometrial cancer patients in this context.
ADCs are a targeted cancer therapy that focuses more of the medication on tumor cells while minimizing harm to healthy cells. Sac-TMT is delivered every two weeks via IV infusion. The trial consisted of 776 patients with endometrial cancer who had experienced disease progression after both platinum chemotherapy and immunotherapy.
These patients were randomly assigned either sac-TMT or a treatment of the physician’s choice, such as doxorubicin or paclitaxel chemotherapy. Patients knew which treatment they received. Those administered sac-TMT exhibited “clinically meaningful improvement” compared to those on the physician’s choice treatment.
The study also met response rate targets and showed side effects similar to previous studies of this drug, according to Merck. Although specific statistics on survival benefit, response rate, and side effects were not disclosed, researchers plan to present the Phase 3 data at a future medical meeting.
Lead researcher Dr. Domenica Lorusso from Humanitas University noted that these findings could address a critical unmet need for patients with advanced endometrial cancer, a disease with increasing incidence and mortality worldwide. She emphasized that despite recent advances, new options remain urgently needed for patients whose disease progresses after platinum and immunotherapy treatments.
Dr. Brian Slomovitz, co-director of gynecologic oncology at Mount Sinai and an investigator on the trial, highlighted the increasing number of endometrial cancer cases and deaths, surpassing even ovarian cancer in mortality rates. The necessity for better treatment options for recurrent disease remains a pressing issue.
If the full data confirm the initial announcement, key considerations will focus on the extent of survival benefit and the drug’s toxicity profile. An improvement in overall survival in recurrent disease presents a meaningful result for patients and their families, not just a statistic.
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