Dr Santin on the Investigation of Sacituzumab Govitecan in Endometrial Cancer

Alessandro Santin, MD, professor, Obstetrics, Gynecology, and Reproductive Sciences, Disease Aligned Research Team Leader, Gynecologic Oncology Program, co-chief, Section of Gynecologic Oncology, Yale Cancer Center, discusses the investigation of sacituzumab govitecan-hziy (Trodelvy) in patients with recurrent endometrial carcinoma overexpressing TROP2.

Investigators launched a 2-stage phase 2 clinical trial (NCT04251416) to evaluate the use of sacituzumab govitecan in this patient population. The preliminary responses from this study were presented at the 2023 ASCO Annual Meeting.

Endometrial cancer is the most common gynecological cancer in the United States, with tens of thousands new cases and deaths every year, Santin begins. When patients develop recurrent disease and become resistant to carboplatin plus paclitaxel, the current gold standard treatment approach in the recurrent- and advanced-stage disease setting, they have limited subsequent treatment options, he explains. Most of the patients evaluated in the phase 2 trial had disease that was resistant to prior chemotherapy, as well as lenvatinib (Lenvima) pluspembrolizumab (Keytruda), which is a new combination in the recurrent setting, Santin adds.

As patients with disease that is resistant to both chemotherapy and lenvatinib plus pembrolizumab have limited treatment options, the phase 2 trial investigators aimed to determine the activity of sacituzumab govitecan in this population, Santin expands. Sacituzumab govitecan is an antibody-drug conjugate that targets TROP2, a glycoprotein that is overexpressed in most endometrial cancers and conjugated through a linker with the toxic payload SN-38, which is a derivative of the topoisomerase 1 inhibitor irinotecan, he explains.

This study enrolled 21 evaluable patients in the first stage. Per the trial design, the first stage would be considered positive if at least 3 clinical responses after 21 patients enrolled role, he notes. Importantly, the response rate detected in the first 21 patient was 33.3%, Santin emphasizes. Overall, these positive findings from stage 1 supportcontinued accrual to the second stage of the study, Santin concludes.