雲頂新耀-B(01952.HK)：國家藥品監督管理局批准TrodelvyTM用於治療轉移性乳腺癌的3期藥物臨試申請
格隆匯 11 月 2日丨雲頂新耀-B(01952.HK)發佈公告，中國國家藥品監督管理局通過了TrodelvyTM (sacituzumab govitecan)用於治療至少兩種既往化療方案治療失敗的激素受體陽性╱人表皮生長因數受體2陰性(“HR+╱HER2-”)轉移性乳腺癌(“mBC”)的臨牀試驗申請(“CTA”)。
隨着臨牀試驗申請的獲批，公司計劃啟動3期註冊臨牀試驗EVER-132-002，這項試驗旨在評估和比較sacituzumab govitecan與醫生選擇的治療(TPC)在接受過至少2種但不超過4種既往化療方案的HR+╱HER2-轉移性乳腺癌的亞洲患者的有效性和安全性。該試驗將在中國大陸、中國台灣地區和韓國招募大約330名HR+╱HER2-轉移性乳腺癌患者。
在中國，HR+╱HER2-乳腺癌是最為常見的一種乳腺癌亞型，佔所有乳腺癌病例的60%多。這一亞型的進展與雌激素或孕激素相關，而且最開始可能對激素治療敏感，但幾乎所有的HR+╱HER2-轉移性乳腺癌隨着時間都會變得耐藥。
根據披露，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2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，可顯著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。
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