雲頂新耀-B(01952.HK)：三陰性乳腺癌治療藥物2b期註冊臨牀試驗首例患者給藥完成
格隆匯 11 月 3日丨雲頂新耀-B(01952.HK)宣佈，在中國開展的TrodelvyTM (sacituzumabgovitecan, IMMU-132)用於治療接受過至少兩線既往治療的轉移性三陰性乳腺癌(mTNBC)的2b期註冊臨牀試驗EVER-132-001完成首例患者給藥。EVER-132-001是一項單臂、多中心的2b期註冊臨牀試驗，其研究目的旨在在接受過至少兩線既往標準化療方案的mTNBC的中國患者中評估sacituzumab govitecan的有效性和安全性，將在中國招募約80名mTNBC患者。作為全球首個獲批用於治療mTNBC的抗體藥物偶聯物(ADC)，sacituzumabgovitecan已被納入最新更新的2020版《中國晚期乳腺癌規範診療指南》，我們相信這將有助於提高晚期乳腺癌治療的標準化與創新，與全球標準保持同步。
據悉，Sacituzumab govitecan是一款同類首創的抗體藥物偶聯物，靶點為TROP-2，其為在許多常見的上皮癌中有過度表達的膜抗原。Sacituzumab govitecan於2020年4月獲得美國食品藥品管理局的加速審批用於治療接受過至少兩線既往針對轉移性疾病治療的mTNBC患者。Immunomedics(現為吉利德科學公司的一部分)在2020年9月歐洲腫瘤內科學會(ESMO)年會發表的驗證性3期臨牀試驗(ASCENT)結果表明，在接受過既往治療的轉移性三陰性乳腺癌患者中，sacituzumab govitecan與標準單藥化療相比，可顯着提升患者的無進展生存期和總生存期，其風險比分別為0.41和0.48。根據與Immunomedics簽署的授權引進協議，公司擁有sacituzumab govitecan在大中華區、韓國和部分東南亞國家的研發、註冊和商業化的權利。
2020年10月，Sacituzumab govitecan被納入最新更新的2020版《中國晚期乳腺癌規範診療指南》，該指南由中國的國家腫瘤質控中心乳腺癌專家委員會、中國抗癌協會乳腺癌專業委員會、中國抗癌協會腫瘤藥物臨牀研究專業委員會共同編撰。
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