AI Insight
A Phase II clinical trial found that sacituzumab govitecan (SG), an antibody-drug conjugate currently FDA-approved for breast cancer, demonstrated meaningful clinical activity in patients with recurrent endometrial cancer who had previously undergone one to four lines of therapy. In the study, 28% of patients achieved tumor reduction or disappearance at a median follow-up of 11 months, with median progression-free survival of 5.5 months and median overall survival of 17.5 months. The drug showed activity not only against common endometrioid tumors but also against more aggressive subtypes including uterine serous carcinoma and carcinosarcoma, with manageable side effects and no major safety concerns.
Why it matters
Uterine cancer is the most common gynecological cancer worldwide, and patients with recurrent disease who have exhausted multiple prior therapies have limited treatment options, making this a clinically significant potential addition to available therapies. These findings may support further investigation toward regulatory approval of SG for uterine cancer indications.
Newswise — A Phase II clinical trial (NCT04251416) has found that the cancer therapeutic sacituzumab govitecan (SG)—also known as Trodelvy—showed encouraging clinical activity in patients with recurrent uterine cancer. The study, led by Yale Cancer Center researchers at Yale School of Medicine, was published May 14 in Clinical Cancer Research, a journal of the American Association for Cancer Research.
SG is an antibody-drug conjugate, a targeted cancer therapy that combines monoclonal antibodies with chemotherapy drugs. It’s currently approved by the U.S. Food and Drug Administration for treatment of breast cancer. The trial investigated the activity of SG in patients with recurrent endometrial cancer who had received one to four different therapies prior to the trial.
The trial found that 28% of patients who received SG experienced tumor reduction or disappearance at a median follow-up of 11 months post-treatment. Specifically, 4% of patients had no detectable signs of cancer following treatment and 24% had significantly reduced tumor size. The median duration of these clinical benefits was 9.3 months.
In addition, median progression-free survival (in which 50% of patients have not experienced worsening disease) and median overall survival (50% of patients are alive) were 5.5 months and 17.5 months, respectively.
“The results of our Investigator Initiated Trial complement and extend the TROPiCS-03 Trial results by demonstrating significant clinical activity of SG not only against the most common histological types of uterine cancer (endometrioid tumors) but also in patients harboring biologically aggressive endometrial tumors such as uterine serous carcinoma and carcinosarcoma,” says Alessandro Santin, MD, the study’s first author.
Santin is a professor of obstetrics, gynecology, and reproductive sciences at Yale School of Medicine and clinical research team leader for Gynecological Oncology as well as co-chief of the Section of Gynecologic Oncology at Yale Cancer Center.
“My laboratory and Yale’s Division of Gynecologic Oncology have been involved in the preclinical and clinical development of this antibody-drug conjugate since the beginning of its development. This is a major ‘bench-to-bedside’ accomplishment for patients with uterine cancer,” he adds.
No safety concerns were identified in the trial, and patients experienced manageable side effects such as fatigue and nausea. This treatment provides a potential new option for patients who have already received multiple lines of chemotherapy and immunotherapy. The findings are hopeful for patients with uterine cancer, which is the most common gynecological cancer worldwide.
The trial was sponsored by Gilead Sciences, Inc.