Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer

作者：Sara M Tolaney, E. de Azambuja, Kevin Kalinsky, Sherene Loi, Sung-Bae Kim, Clinton Yam, Bernardo L. Rapoport, Seock-Ah Im, Barbara Pistilli, Wassim McHayleh, D Cescon, Junichiro Watanabe, Manuel Alejandro Lara Bañuelas, Ruffo Freitas-Junior, Javier Salvador Bofill, Maryam Afshari, Dianna Gary, Lu Wang, C. Lai, Peter Schmid · 发表于：New England Journal of Medicine · 年份：2026 · DOI：10.1056/nejmoa2508959 · 被引用次数：40 · 研究领域：Cancer Immunotherapy and Biomarkers、HER2/EGFR in Cancer Research、Advanced Breast Cancer Therapies

BACKGROUND: Triple-negative breast cancer is an aggressive breast cancer subtype, and there remains an unmet need to improve outcomes in patients with previously untreated, programmed death ligand 1 (PD-L1)-positive, locally advanced unresectable or metastatic triple-negative breast cancer. METHODS: In this phase 3, open-label, international trial, we randomly assigned patients in a 1:1 ratio to receive sacituzumab govitecan plus pembrolizumab or chemotherapy plus pembrolizumab. The primary end point was progression-free survival as assessed by blinded independent central review. Secondary end points included overall survival, objective response (complete or partial response) and duration of response as assessed by blinded independent central review, and safety. RESULTS: A total of 443 patients were randomly assigned to receive sacituzumab govitecan plus pembrolizumab (221 patients) or chemotherapy plus pembrolizumab (222 patients). The median progression-free survival was 11.2 months (95% confidence interval [CI], 9.3 to 16.7) with sacituzumab govitecan plus pembrolizumab and 7.8 months (95% CI, 7.3 to 9.3) with chemotherapy plus pembrolizumab (hazard ratio for disease progression or death, 0.65; 95% CI, 0.51 to 0.84; two-sided P<0.001). Data for overall survival were immature. The percentage of patients with an objective response was 60% (95% CI, 53 to 66) with sacituzumab govitecan plus pembrolizumab and 53% (95% CI, 46 to 60) with chemotherapy plus pembrolizumab; among pa...