基石藥業-B(02616.HK):avapritinib 針對中國三線GIST患者的全球III期VOYAGER試驗完成入組目標
格隆匯12月10日丨基石藥業-B(02616.HK)公告,由基石藥業合作伙伴Blueprint Medicines Corporation(納斯達克股份代號:BPMC)開發的在研產品avapritinib,在一項正在進行的全球III期VOYAGER臨牀研究中完成了中國患者入組目標。此外,VOYAGER研究的全球患者入組目標也已達成。該研究旨在評估相較於目前三線胃腸道間質瘤標準治療藥物瑞戈非尼,avapritinib作為晚期GIST患者三線或四線治療的安全性和療效。於2019年7月10日,基石藥業宣佈VOYAGER研究實現首例中國患者給藥。
Blueprint預計將於2020年第二季度公佈VOYAGER研究的主要試驗數據。2019年8月,美國食品藥品監督管理局已接受Blueprint關於avapritinib用於無論前是否接受過治療的、攜帶PDGFRA外顯子18突變的GIST以及四線GIST成人患者的新藥上市申請。根據初步審批情況,Blueprint計劃於2020年下半年向FDA遞交avapritinib用於三線GIST治療的補充上市申請。基石藥業也計劃在2020年下半年向國家藥品監督管理局遞交avapritnib用於三線GIST治療的新藥上市申請。
GIST是最常見的腸胃道間質腫瘤,在50至80歲間的患者中最為普遍。大約90%的GIST病例與KIT或PDGFRA酪氨酸激酶基因突變導致的細胞生長失調有關。現有數據顯示,目前GIST的三線標準治療藥物瑞戈非尼的中位無進展生存期為4.8個月,客觀緩解率僅為5%左右。而經三線治療失敗的GIST患者目前尚無已獲批的治療。因此對於三線及以後的GIST患者仍存在極大的未滿足臨牀需求。
Avapritinib是一款在研的口服、強效、高選擇性的KIT和PDGFRA抑制劑。臨牀試驗數據顯示,avapritinib在PDGFRA外顯子18突變(主要包括D842V突變)GIST和四線GIST患者中均顯示出令人鼓舞的抗腫瘤活性和良好的耐受性,目前針對這兩類患者尚無有效治療方法。
基石藥業董事長、執行董事兼首席執行官江寧軍表示:"很高興看到全球III期VOYAGER研究中國患者入組目標比我們預期的更快達成,這也讓我們感受到了中國GIST患者急切的臨牀需求。隨着趙萍正式加盟基石藥業,出任大中華區總經理兼商業化負責人,相信這位曾成功主導過多款知名藥物上市的資深醫藥行業經理人將進一步助推基石藥業商業化進程。我們對包括avapritinib在內的多款藥物在中國成功上市充滿了信心。"
基石藥業首席醫學官楊建新表示:"GIST是一種罕見病,能夠在不到4個月的時間內完成中國患者入組目標,離不開基石藥業、研究者及合作伙伴等多方的通力合作。作為一款針對KIT及PDGFRA突變激酶的高選擇性抑制劑,目前公佈的臨牀試驗數據已顯示出它的治療潛力。目前,avapritinib還有一項針對晚期GIST患者的I/II期橋接註冊性試驗也正在中國開展。"
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