a Department of Pharmacy , Massachusetts General Hospital , Boston , USA.
b Massachusetts General Hospital Cancer Center , Harvard Medical School , Boston , USA.
Expert Opin Investig Drugs. 2019 Feb;28(2):107-112. doi: 10.1080/13543784.2019.1555239. Epub 2018 Dec 17.
Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer that disproportionately impacts younger women and is associated with a poor prognosis. Systemic treatment options for metastatic TNBC (mTNBC) are limited to cytotoxic chemotherapy agents with low response rates. This encouraged the clinical development of sacituzumab govitecan (IMMU-132), an antibody-drug conjugate targeting Trop-2, a potential target in epithelial cancer such as TNBC. Areas covered: We summarize the key features, pharmacokinetics, and the safety and efficacy data of sacituzumab govitecan. We also discuss the future directions of this novel therapeutic agent for mTNBC. Expert opinion: Based on the efficacy and tolerability observed in the phase 1/2 clinical trial, sacituzumab govitecan was granted breakthrough therapy designation by the Food and Drug Administration as ≥3 line therapy for mTNBC. Novel treatment modalities for the management of mTNBC are necessary to improve the care of this aggressive disease. Sacituzumab govitecan represents an important advance in the treatment of mTNBC because of its efficacy and tolerability.
三阴性乳腺癌（TNBC）是一种侵袭性乳腺癌亚型，不成比例地影响年轻女性，并且预后不良。转移性三阴性乳腺癌（mTNBC）的系统治疗选择仅限于细胞毒性化疗药物，其反应率低。这鼓励了针对 Trop-2 的抗体药物偶联物 sacituzumab govitecan（IMMU-132）的临床开发，Trop-2 是 TNBC 等上皮性癌症的潜在靶点。 涵盖领域：我们总结了 sacituzumab govitecan 的关键特征、药代动力学以及安全性和疗效数据。我们还讨论了这种新型治疗剂在 mTNBC 中的未来方向。 专家意见：基于 I/II 期临床试验中观察到的疗效和耐受性，sacituzumab govitecan 被美国食品和药物管理局授予突破性治疗指定，用于 mTNBC 的三线以上治疗。为改善这种侵袭性疾病的治疗，需要新型治疗方法来管理 mTNBC。由于其疗效和耐受性，sacituzumab govitecan 代表了 mTNBC 治疗的重要进展。
