基石藥業-Ｂ(02616.HK)：CS1001聯合化療一線治療食管鱗癌III期臨牀試驗完成首例患者給藥
格隆匯1月7日丨基石藥業-Ｂ(02616.HK)發佈公告，公司抗PD-L1單抗CS1001聯合化療一線治療晚期食管鱗癌的III期臨牀試驗已完成首例患者給藥。該項名為GEMSTONE-304的多中心臨牀試驗，旨在評估CS1001聯合氟尿嘧啶和順鉑(“FP”)化療方案作為一線治療在不可手術切除的局部晚期、復發或轉移性食管鱗癌患者中的療效和安全性。
據統計，約90%的中國食管癌患者為食管鱗癌，且約70%的食管鱗癌患者在確診時已為局部晚期或晚期轉移性。目前晚期食管鱗癌患者的標準一線治療方案為含鉑類藥物的雙藥化療方案，但療效非常有限。研究資料顯示，經過該一線方案治療的晚期食管鱗癌患者，客觀有效率(“ORR”)約為35%，中位無進展生存期不足半年，中位總生存期不到一年，且患者暫無其它有效治療選擇。
CS1001是由基石藥業開發的在研抗PD-L1單克隆抗體。根據2019年中國臨牀腫瘤學會年會上公佈的研究資料，截至2019年7月1日，在CS1001聯合FP方案用於一線食管鱗癌的1b期臨牀試驗中，ORR達到77.8%，且緩解可持續，同時，總體安全性及耐受性良好。
基石藥業董事長、執行董事兼首席執行官江寧軍博士表示：“食管癌是具有中國特色的高發癌種，中國發病和死亡人數佔到全球50%以上。然而，目前中國針對食管鱗癌的治療手段已多年未取得突破，患者在臨牀上存在長期、迫切的未滿足需求。我很高興看到GEMSTONE-304研究完成了首例受試者給藥，期待CS1001能延續其在初步研究中顯示出的巨大治療潛力，早日成為中國食管鱗癌患者新的治療選擇。”
基石藥業首席醫學官楊建新博士表示：“由於食管癌早期症狀隱匿，患者確診時往往已處於晚期，治療手段十分有限,且目前尚無免疫藥物獲批用於一線食管鱗癌的治療。目前已公佈的Ib期臨牀研究資料表明，CS1001在晚期食管鱗癌患者中已顯示出良好的初步抗腫瘤活性。我們將全力推進CS1001的該項III期臨牀試驗，如果試驗能夠取得成功，對於急需有效藥物的晚期食管鱗癌患者來説，將是一個巨大的突破。”
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