信達生物(01801.HK)宣佈達伯坦®在中國大陸獲批用於治療成人至少接受過一種系統性治療，且經檢測確認存在有FGFR2融合或重排的晚期、轉移性或不可手術切除的膽管癌
格隆匯4月6日丨信達生物(01801.HK)宣佈，達伯坦®(佩米替尼片，pemigatinib)在中國獲得國家藥品監督管理局(”NMPA“)批准用於既往至少接受過一種系統性治療，且經檢測確認存在有纖維細胞生長因子受體2(”FGFR2“)融合或重排的晚期、轉移性或不可手術切除的膽管癌成人患者的治療。
達伯坦®由Incyte Corporation(”Incyte“)和公司共同開發，公司負責中國大陸、香港、澳門和台灣地區的商業化。該次中國大陸市場獲批是繼2021年6月中國台灣獲批、2022年1月中國香港獲批後的又一重要里程碑，達伯坦®也是首個在中國獲批的選擇性FGFR受體酪氨酸激酶抑制劑。
該適應症的獲批主要基於兩項臨牀研究。一項為在海外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佩米替尼的療效和安全性的II期、開放性、單臂、多中心的研究(FIGHT202研究，NCT02924376)。另一項是在中國進行的多中心、開放性、單臂試驗(研究代號：CIBI375A201, NCT04256980)，目的為評價佩米替尼在中國同類膽管癌受試者的療效和安全性。兩項研究的主要終點都是基於獨立影像委員會(”IRRC“)根據實體瘤評價標準V1.1評價的客觀緩解率(”ORR“)。
FIGHT-202研究中，截止2020年4月7日共入組108例伴有FGFR2重排或融合的膽管癌受試者，接受佩米替尼治療(13.5mg╱ 天，服藥兩週停藥一週)，由IRRC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(”CR“)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12個月。CIBI375A201研究中，截止2021年1月29日，30例療效可評價受試者中的客觀緩解率ORR為50%(95% CI: 31.3%,68.7%)，均為部分緩解。FIGHT-202研究和CIBI375A201研究中受試者總體不良反應發生比例和類別基本一致，絕大多數不良反應為1-2級，整體安全性良好。
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