Dr Santin on the Clinical Activity of Sacituzumab Govitecan in Recurrent Endometrial Cancer

Alessandro Santin, MD, professor, Obstetrics, Gynecology, and Reproductive Sciences, Disease Aligned Research Team Leader, Gynecologic Oncology Program, Yale Cancer Center, co-chief, Section of Gynecologic Oncology, discusses the clinical activity of sacituzumab govitecan-hziy (Trodelvy) in patients with recurrent endometrial cancer who overexpress Trop-2.

Preliminary results from stage 1 of a phase 2 trial (NCT04251416) presented at the 2023 ASCO Annual Meeting showed that among 21 patients evaluable for efficacy, the objective response rate was 33.3%, including 1 (4.8%) complete response and 6 (28.5%) partial responses. Additionally, 47.6% of patients had stable disease, and 14.3% experienced progressive disease. Notably, in 20 patients evaluable for disease control, the 6-month durable disease control rate was 35.0%.

Although endometrial cancer is the most common gynecological cancer in the United States, patients who experience recurrence and become resistant to carboplatin and paclitaxel have limited treatment options, Santin begins. In this phase 2 study, patients were required to have progressed on or after treatment with platinum-based chemotherapy. Notably, many patients were resistant to previous chemotherapy, as well as lenvatinib (Lenvima) plus pembrolizumab (Keytruda), Santin explains. Sacituzumab govitecan is an antibody-drug conjugate targeting TROP-2, which is a glycoprotein that is overexpressed in a majority of endometrial cancers, Santin adds.

The study was allowed to proceed to stage 2 after stage 1 met its prespecified statistical goal of at least 3 clinical responses in the first 21 patients enrolled. Enrollment for stage 2 is ongoing, and the study will feature 50 total patients between the 2 stages, Santin concludes.