Sacituzumab Govitecan Shows Encouraging Efficacy, Manageable Safety for Patients With Heavily Pretreated Advanced Endometrial Cancer

Results from the phase 2 TROPiCS-03 study demonstrated that sacituzumab govitecan, a trophoblast cell-surface antigen 2 (Trop-2)–directed antibody-drug conjugate, showed promising efficacy and safety among patients with heavily pretreated advanced or metastatic endometrial cancer. 

According to Alessandro Santin, MD, Yale School of Medicine, New Haven, Connecticut, and coauthors, “In patients with recurrent [endometrial cancer], platinum-based chemotherapy plus pembrolizumab or trastuzumab is the preferred first-line systemic treatment [however] limited treatment options exist for patients with advanced disease after progression.”

In this open-label, basket study, 41 patients with histologically confirmed advanced or metastatic endometrial cancer who experienced disease progression after treatment with platinum-based chemotherapy were enrolled to receive 10 mg/kg of intravenous sacituzumab govitecan once daily on days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR). Secondary end points included clinical benefit rate, duration of response (DOR), progression-free survival (PFS), and safety. 

At a median follow-up of 5.8 months, confirmed ORR was 22% and the clinical benefit rate was 32%. The median DOR was 8.8 months and the median PFS was 4.8 months. Grade ≥ 3 treatment-related adverse events were observed in 73% of patients, and most frequently included diarrhea (20%), anemia (15%), neutropenia (32%), vomiting (5%), and hypokalemia (15%). 

“[Sacituzumab govitecan] showed encouraging activity in a heavily pretreated patient population with advanced/metastatic [endometrial cancer],” concluded Dr Santin et al. 

According to Journal of Clinical Oncology Associate Editor Gini Fleming, MD, University of Chicago, Chicago, Illinois, “these results support a randomized phase 3 trial.” 

Source:

Santin AD, Corr BR, Spira A, et al. Efficacy and safety of sacituzumab govitecan in patients with advanced solid tumors (TROPiCS-03): Analysis in patients with advanced endometrial cancer. J Clin Oncol. Published online: July 31, 2024. doi: 10.1200/JCO.23.02767