信達生物(01801.HK)：達伯坦®治療成人接受過系統性藥物治療、伴FGFR2融合或重排、不可手術切除的局部晚期或轉移性膽管癌在港獲批
格隆匯1月24日丨信達生物(01801.HK)宣佈，達伯坦®(pemigatinib)獲得香港政府衞生署(“DH”)批准用於治療成人既往至少接受過一次系統性治療後疾病進展、伴成纖維細胞生長因數受體2(“FGFR2”)融合或重排、不可手術切除的局部晚期或轉移性膽管癌。
達伯坦®由Incyte Corporation(“Incyte”)和公司共同開發，公司負責中國大陸、香港、澳門和台灣地區的開發和商業化。該次香港地區市場獲批是繼2021年6月於台灣地區市場獲批、2021年7月國家藥品監督管理局(“NMPA”)正式受理新適應症上市申請(“NDA”)後的又一里程碑，達伯坦®也是首個在香港地區市場獲批的治療膽道惡性腫瘤的選擇性FGFR受體酪氨酸激酶抑制劑。
該適應症的獲批主要是基於一項在既往經過至少一線系統性治療失敗的、伴FGFR2融合或重排的、手術不可切除的局部晚期、複發性或轉移性膽管癌受試者中評價達伯坦®的療效和安全性的II期、開放性、單臂、多中心的研究(此研究又稱FIGHT-202研究，NCT02924376)。該研究的主要終點是基於獨立影像委員會根據實體瘤評價標準V1.1評價的客觀緩解率(“ORR”)。截止2020年4月7日，共入組108例伴FGFR2重排或融合的膽管癌受試者入組每天接受13.5mg達伯坦®治療，由獨立中心影像評估的經影像學確認的ORR為37.0%(95% CI: 27.94%,46.86%)，包括4例完全緩解的受試者，中位緩解持續時間(“DOR”)為8.08個月，其中40例出現腫瘤緩解的受試者中有26例(66%)受試者的緩解持續時間大於等於6個月，15例(37.5%)受試者緩解持續時間大於等於12個月。共有147例受試者被納入安全性分析，結果顯示達伯坦®具有良好的耐受性。其中高磷酸血癥為最常見的不良反應，發生率為58.5%。有68.7%的受試者發生3級或以上的不良反應，其中以低磷酸鹽血癥(14.3%)、關節痛(6.1%)、口腔黏膜炎(6.1%)、低鈉血癥(5.4%)、腹痛(5.4%)及疲乏(5.4%)最為常見。
膽管癌是第二常見的原發於肝臟的惡性腫瘤。乙肝病毒及其他肝臟寄生蟲的感染導致其在亞洲地區發病率較高。大部份膽管癌患者首次診斷時腫瘤即處於無法切除或者轉移的狀態，治療手段有限。Pemigatinib在既往經過至少一線標準治療失敗的存在FGFR2融合的晚期膽管癌患者的臨牀試驗數據結果展示出了pemigatinib令人滿意的安全性及療效。鑑於難治性人羣的治療挑戰性增加，以及目前研究中觀察到的數據頗具前景，公司相信伴FGFR2融合或重排的患者可能會從靶向治療中獲益。
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