Study reveals objective response rate of 22 percent and clinical benefit rate of 32 percent
By Elana Gotkine HealthDay Reporter
WEDNESDAY, Aug. 14, 2024 (HealthDay News) — For patients with advanced endometrial cancer (EC), sacituzumab govitecan (SG), a trophoblast cell-surface antigen 2 (Trop-2)-directed antibody-drug conjugate, shows encouraging efficacy, according to a phase 2 study published online July 31 in the Journal of Clinical Oncology.
Alessandro D. Santin, M.D., from the Yale School of Medicine in New Haven, Connecticut, and colleagues conducted a phase 2 basket study to examine the efficacy and safety of SG in patients with advanced EC. Eligible patients received SG 10 mg/kg once on days 1 and 8 every three weeks; median follow-up was 5.8 months. The primary end point was the objective response rate.
Forty-one patients were enrolled at the data extraction date; the median previous therapies was three, and 85 percent of participants received previous chemotherapy and immunotherapy. The researchers found an objective response rate of 22 percent and a clinical benefit rate of 32 percent. The median duration of response was 8.8 months, and median progression-free survival was 4.8 months. For 39 patients, a Trop-2 exploratory analysis was conducted retrospectively. There was high expression of tumor Trop-2 protein in EC, with limited correlation seen with efficacy. Seventy-three percent of patients had grade ≥3 treatment-related adverse events (TRAEs). Discontinuation of study drugs due to TRAEs was 5 percent. There were two deaths, which were unrelated to SG.
“On the basis of the results from this trial, a randomized phase III study is planned,” the authors write.
Several authors disclosed ties to pharmaceutical companies, including Gilead Sciences, which manufactures sacituzumab govitecan and funded the study.
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