中國生物製藥(01177.HK)：1類新藥安羅替尼聯合化療一線治療晚期軟組織肉瘤III期臨牀試驗順利完成受試者入組
格隆匯12月22日丨中國生物製藥(01177.HK)公吿，集團正在開展一項"評價鹽酸安羅替尼膠囊聯合注射用鹽酸表柔比星對比安慰劑聯合注射用鹽酸表柔比星一線治療晚期軟組織肉瘤有效性和安全性的多中心、隨機、雙盲、平行對照III期臨牀試驗"，近期已順利完成全部受試者入組。
軟組織肉瘤(STS)是高度異質性腫瘤，其特點：局部侵襲性、呈浸潤性或破壞性生長、可局部復發和遠處轉移，具有19個組織類型和50個以上的不同亞型，可發生於身體任何部位。軟組織肉瘤發病率大約為1.28/10萬~1.72/10萬，可發生於任何年齡人羣，男性略多於女性。對於不可切除的局部晚期或轉移性軟組織肉瘤，儘管不同肉瘤亞型對化療藥物的敏感性不同，局部晚期或轉移性軟組織肉瘤一線治療仍推薦以蒽環類藥物為主的姑息化療。
鹽酸安羅替尼膠囊是本集團研發的一款多靶點受體酪氨酸激酶抑制劑。2011年3月獲得國家食品藥品監督管理局臨牀研究批件，2018年5月獲批上市用於經治的晚期非小細胞肺癌患者，後相繼獲批軟組織肉瘤、小細胞肺癌、甲狀腺髓樣癌和分化型甲狀腺癌適應症。其聯合貝莫蘇拜單抗(抗PD-L1)及化療一線治療小細胞肺癌的適應症正在國家藥品監督管理局藥品審評中心(CDE)技術審評中。
安羅替尼聯合表柔比星序貫安羅替尼一線治療晚期軟組織肉瘤早期探索研究結果已發表於ClinicalCancerResearch，研究結果顯示，聯合治療客觀緩解率(ORR)為13.3%，疾病控制率(DCR)為80%，中位無進展生存期(mPFS)達11.5個月，且安全可耐受。安羅替尼聯合表柔比星一線治療晚期軟組織肉瘤III期臨牀試驗已順利完成全部受試者入組，標誌着安羅替尼在軟組織肉瘤適應症從後線進入一線的上市進程邁出了關鍵性一步，也意味着安羅替尼聯合化療有望為一線軟組織肉瘤患者帶來全新的治療選擇。
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