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基石藥業(02616.HK):avapritinib可使PDGFRA D842V突變型GIST患者達到持久臨牀獲益,研究發表於“柳葉刀腫瘤學”
格隆匯 07-06 16:37

格隆匯7月6日丨基石藥業-B(02616.HK)發佈公告,公司的合作伙伴 Blueprint Medicines Corporation (Blueprint Medicines,納斯達克股份代號:BPMC)於6月29日宣佈,“柳葉刀腫瘤學”發表了 NAVIGATOR 臨牀試驗結果,資料顯示 avapritinib 用於 PDGFRA D842V 突變型晚期胃腸間質瘤(“GIST”)患者,24個月的總生存(「OS」)率達到 81%,且耐受性良好。該研究報告2020年6月29日正式發表於“柳葉刀腫瘤學”,文章標題為“avapritinib 治療晚期 PDGFRA D842V 突變型胃腸間質瘤(NAVIGATOR):一項多中心、開放標籤的一期研究”。

Blueprint Medicines 已與基石藥業達成獨家合作及授權授權合約,在中國內地和香港特別行政區、澳門特別行政區及中國台灣推進 avapritinib、fisogatinib 和 pralsetinib 的研發和商業化。 Blueprint Medicines 將保留以上相關產品在全球其他國家/地區的研發和商業化權利。

有關重點消息包括:發表於“柳葉刀腫瘤學”上的文章報告了 NAVIGATOR 試驗的有效性和安全性結果,包括劑量遞增階段的所有患者,以及擴展階段的 PDGFRA D842V 突變型 GIST 亞組患者。療效分析人羣包括56例 PDGFRA D842V 突變型 GIST 患者。安全性分析人羣包括82例患者,其中包括劑量遞增研究階段的26例非 PDGFRA D842V 突變型 GIST 患者。所有資料截止日期為2018年11月16日;

資料顯示,接受 avapritinib 治療的 PDGFRA D842V 突變型 GIST 患者中,總體緩解率達到 88%(95% CI:76%-95%),有 9%的患者達到完全緩解。avapritinib 治療在這一患者人羣中顯示出了持久的臨牀獲益,12個月持續緩解率為 70%(95% CI: 54%-87%),12個月無進展生存率為 81%(95% CI:69%-93%),24個月總生存率為 81%(95% CI:67%-94%);

avapritinib 總體耐受性良好,研究中報告的治療相關不良事件大部分為一級或二級。最常見的治療相關不良事件為噁心、疲乏、腹瀉、眶周水腫、貧血、食慾減退、嘔吐和記憶力減退。40%的患者出現認知障礙,大多數報告的事件為一級。

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