和黃醫藥(00013.HK)在日本啟動索凡替尼治療晚期神經內分泌瘤註冊性橋接研究
格隆匯9月20日丨和黃醫藥(00013.HK)發佈公吿，和黃醫藥已啟動一項索凡替尼的日本註冊性橋接研究，以支持索凡替尼用於治療晚期神經內分泌瘤的藥品上市註冊。首名患者已於2021年9月15日接受給藥治療。
根據與日本藥品和醫療器械局(PMDA)的溝通確定，索凡替尼用於治療晚期神經內分泌瘤的日本新藥上市申請包括將在日本進行的一項關鍵性研究的結果，以補充支持用於向美國食品藥品監督管理局(“FDA”)提交新藥上市申請(於2021年6月獲受理)和向歐洲藥品管理局(“EMA”)提交上市許可申請(MAA)(於2021年7月獲確認)所使用的註冊數據包。上述新藥上市申請和上市許可申請是基於來自美國I/II期研究，以及支持了索凡替尼在中國用於治療晚期神經內分泌瘤的上市許可的已完成的SANET-ep和SANET-pIII期研究數據。目前索凡替尼在中國以商品名蘇泰達®(SULANDA®)上市銷售。
該項日本研究是一項索凡替尼的兩階段、開放標籤研究，預計將招募約34名患者。在研究的第一階段，復發或難治性非血液惡性腫瘤患者將接受28天每日一次300mg給藥治療，並評估索凡替尼的安全性及耐受性；次要終點為索凡替尼的藥代動力學特徵及抗腫瘤活性。研究的第二階段，將評估索凡替尼治療局部晚期或轉移性神經內分泌瘤患者的療效；主要結果指標為客觀緩解率(“ORR”)；次要結果指標包括疾病控制率(“DCR”)、無進展生存期(“PFS”)、緩解持續時間(“DoR”)、安全性及藥代動力學特徵。
索凡替尼是和黃醫藥第三款在日本進入臨牀開發的自主研發潛在新藥。目前，呋喹替尼(fruquintinib)的全球III期註冊研究FRESCO-2研究正在難治性轉移性結直腸癌患者中進行，計劃將於包括日本在內全球14個國家的超過150家研究中心招募逾680名患者。賽沃替尼(savolitinib)(與阿斯利康合作)與泰瑞沙®(TAGRISSO®)聯合療法的全球單臂、開放標籤研究SAVANNAH研究正在因MET擴增或過表達導致泰瑞沙®治療後疾病進展的非小細胞肺癌患者中進行。
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