Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
A Phase II Evaluation of the Efficacy and Safety of Sacituzumab Govitecan in Patients with Recurrent Uterine Cancer.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Santin Alessandro D, Roque Dana M, Siegel Eric R, Ettorre Victoria M, Greenman Michelle, McNamara Blair, Papatla Katyayani, Kailasam Aparna, Buza Natalia, Clark Mitchell, Hui Pei, Dottino Peter, Ratner Elena, Bellone Stefania
Аннотация
PURPOSE: Patients 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 METHODS: This 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.
RESULTS: Fifty 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.
CONCLUSIONS: SG demonstrated encouraging efficacy in a pretreated population that included biologically aggressive recurrent endometrial cancer. Adverse events were consistent with the known safety profile.
PATIENTS AND METHODS: This 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.
RESULTS: Fifty 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.
CONCLUSIONS: SG demonstrated encouraging efficacy in a pretreated population that included biologically aggressive recurrent endometrial cancer. Adverse events were consistent with the known safety profile.