Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026
A Phase II Evaluation of the Efficacy and Safety of Sacituzumab Govitecan in Patients with Recurrent Uterine Cancer.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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14 authors.
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Abstract
purposePatients with endometrial cancer who progress after chemotherapy/immunotherapy have limited treatment options. We evaluated the activity and safety of sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, in patients with advanced/recurrent endometrial cancer, including carcinosarcoma. PATIENTS AND
methodsThis was a phase II, two-stage, open-label, investigator-initiated trial of patients with persistent/recurrent endometrial cancer who had progressed following ≥1 prior chemotherapy. Patients received SG 10 mg/kg on days 1 and 8 every 3 weeks. The primary endpoint was objective response rate (ORR) by RECIST v1.1. Secondary endpoints included clinical benefit rate [CBR = complete response (CR) + partial response (PR) + stable disease ≥ 6 months], duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. Trop-2 expression was analyzed by immunohistochemistry as an H-score.
resultsFifty patients were screened, and 21 enrolled during stage 1; 34 patients were screened, and 29 enrolled during stage 2; 84% (n = 42) of the patients harbored serous carcinoma, carcinosarcoma, or grade 3 endometrioid tumors. Patients received a median of two prior therapies (range, 1-4) and 50% had failed pembrolizumab/dostarlimab. At a median follow-up (range) of 11 (2.9-65.5) months, the ORR was 28% [95% confidence interval (CI), 16%-42%], including CRs (4%) and PRs (24%). The median DOR (95% CI) was 9.3 (2-12.9) months, with four still responding. The CBR was 52% (26/50). The median PFS and OS were 5.5 (95% CI, 3.7-7.4) and 17.5 (95% CI, 10.4-22.2) months, respectively. Grade 3 to 4 toxicity occurred in 88% with no attributable deaths. Mean H-scores did not predict response.
conclusionsSG demonstrated encouraging efficacy in a pretreated population that included biologically aggressive recurrent endometrial cancer. Adverse events were consistent with the known safety profile.
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