基石藥業-Ｂ(02616.HK)：CS1002I期臨牀研究初步結果CS1002表現與ipilimumab相當
格隆匯9月22日丨基石藥業-Ｂ(02616.HK)發佈公告，公司在第二十二屆中國臨牀腫瘤學會(“CSCO”)年會上，以口頭報告形式公佈了公司的在研抗CTLA-4單抗CS1002的Ia期試驗初步結果，這也是CS1002臨牀研發首次在學術大會上作數據披露。
CS1002-101是一項在澳洲開展的針對晚期實體瘤患者的開放性、多劑量給藥的劑量探索和擴展研究，旨在評估CS1002的安全性、耐受性、藥代動力學、藥效動力學和初步抗腫瘤活性。目前該試驗已完成CS1002單藥劑量爬坡部分。
研究數據由澳洲St Vincent醫院Kinghorn癌症中心腫瘤科的腫瘤學家Rasha Cosman醫學博士進行報告。Cosman博士表示：“研究數據顯示，CS1002顯示出良好的耐受性。在數據截止日期前，直至10mg/kg的劑量組均未觀察到劑量限制毒性，且未達到最大耐受劑量。此外，目前CS1002的安全性、初步有效性、藥代動力學及藥效動力學初步結果都與ipilimumab相當。”
基石藥業董事長、執行董事兼首席執行官江寧軍博士表示：“目前，全球僅有一款CTLA-4抑制劑ipilimumab獲批，且尚未在中國上市。很高興看到CS1002在Ia期研究中取得了良好的初步數據，未來我們計劃開展CS1002與CS1003(一款抗PD-1抗體)聯合給藥的劑量爬坡研究及在特定瘤種中的劑量擴展研究。我們期待基石藥業這兩款腫瘤免疫骨幹產品能夠在聯合療法中有優異的臨牀表現，早日惠及更多腫瘤患者。”
基石藥業首席轉化醫學官謝毅釗博士表示：“從作用機制上來説，抗CTLA-4單抗是通過阻斷CTLA-4的免疫效應刺激免疫細胞大量增殖，從而誘導或增強抗腫瘤免疫反應。這一作用機制意味着這類藥物在癌症治療方面有着廣泛的應用前景。而CS1002作為一種全長、全人源IgG1單克隆抗體，與ipilimumab具有相同的氨基酸序列。我們期待它能成為繼ipilimumab之後的另一款明星CTLA-4抑制劑。”
截至數據截止日2019年4月25日，CS1002-101劑量遞增期已入組13例晚期實體瘤患者，包括4例結直腸癌、2例轉移性腺癌及7例其它實體瘤患者。其中，6例患者接受了每三週一次的CS10021mg/kg劑量給藥，3例接受了3mg/kg劑量給藥及4例接受了10mg/kg劑量給藥。至資料截止日，2例患者仍在治療。
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