恆瑞醫藥(600276.SH)：相關SHR-1210-Ⅲ-310研究被判定主要研究終點結果達到方案預設的優效標準
格隆匯5月12日丨恆瑞醫藥(600276.SH)公佈，近日，江蘇恆瑞醫藥股份有限公司及子公司蘇州盛迪亞生物醫藥有限公司研發的注射用卡瑞利珠單抗聯合甲磺酸阿帕替尼片的國際多中心Ⅲ期臨牀試驗(SHR-1210-Ⅲ-310)由獨立數據監察委員會(IDMC)判定主要研究終點結果達到方案預設的優效標準。
研究結果表明卡瑞利珠單抗聯合阿帕替尼對比索拉非尼作為一線治療可以顯著延長晚期肝細胞癌患者的無進展生存期(PFS)以及總生存期(OS)。
卡瑞利珠單抗聯合阿帕替尼用於既往未接受過系統治療的不可切除或轉移性肝細胞癌患者的一線治療的上市許可申請已獲得中國國家藥品監督管理局受理，公司也計劃近期向美國食品藥品監督管理局遞交新藥上市的溝通交流申請。
SHR-1210-Ⅲ-310研究是一項評估卡瑞利珠單抗聯合阿帕替尼對比索拉非尼治療既往未接受過系統治療的不可切除或轉移性肝細胞癌患者有效性和安全性的隨機對照、開放性、國際多中心Ⅲ期臨牀研究，由南京金陵醫院腫瘤中心秦叔逵教授擔任全球主要研究者，全球13個國家和地區的95家中心共同參與。研究主要終點是由獨立評審委員會(BIRC)基於RECISTv1.1標準評估的無進展生存期(PFS)和總生存期(OS)，次要終點包括疾病進展時間(TTP)、客觀緩解率(ORR)、疾病控制率(DCR)、客觀緩解持續時間(DoR)、安全性等。
該研究共入組543名受試者，按照1:1隨機入組，分別接受卡瑞利珠單抗(200mg，每2周注射1次)聯合阿帕替尼(250mg，每日口服1次)或索拉非尼(400mg，每日口服2次)治療。研究結果表明，卡瑞利珠單抗聯合阿帕替尼對比索拉非尼作為一線治療可以顯著延長晚期肝細胞癌患者的無進展生存期(PFS)和總生存期(OS)。
注射用卡瑞利珠單抗是人源化抗 PD-1單克隆抗體，可與人PD-1受體結合並阻斷PD-1/PD-L1通路，恢復機體的抗腫瘤免疫力，從而形成癌症免疫治療基礎。經查詢EvaluatePharma數據庫，2020年抗PD-1抗體全球銷售額約為237.6億美元。截至目前，注射用卡瑞利珠單抗相關項目累計已投入研發費用約20.19億元。
甲磺酸阿帕替尼片是公司創新研發的小分子靶向藥物，經查詢，國內外有索拉非尼、舒尼替尼、培唑帕尼等多種同類產品獲批上市。經查詢EvaluatePharma數據庫，2020年索拉非尼、舒尼替尼和培唑帕尼全球銷售額合計約為21.83億美元。截至目前，甲磺酸阿帕替尼相關項目累計已投入研發費用約4.57億元。
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