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基石藥業(2616.HK)擇捷美®擬遞交新適應症上市申請 有望成為全球首個治療復發難治淋巴瘤免疫治療藥物
格隆匯 01-13 08:33

1月13日,港股創新藥企基石藥業(2616.HK)宣佈其最新獲批上市的PD-L1同類最優藥物擇捷美®(舒格利單抗注射液)治療復發或難治性結外自然殺傷細胞/T細胞淋巴瘤(R/R ENKTL)的註冊性臨牀研究(GEMSTONE-201)達到主要研究終點,研究結果顯示,擇捷美®在R/R ENKTL患者中具有優異的抗腫瘤活性、持久的腫瘤緩解和良好的安全性,具體研究數據也將於近期召開的國際學術會議中公佈。基石藥業計劃近期向中國國家藥品監督管理局(NMPA)遞交擇捷美®針對R/R ENKTL適應症的新藥上市申請,擇捷美®有望成為全球首個針對復發或難治性結外自然殺傷細胞/T細胞淋巴瘤(R/R ENKTL)適應症獲批的免疫治療藥物。

對此,基石藥業首席醫學官楊建新博士表示,很高興看到擇捷美®治療R/R ENKTL的註冊研究達到主要研究終點,這是繼III期和Ⅳ期非小細胞肺癌註冊研究之後,擇捷美®取得成功的第三項關鍵臨牀研究。“目前尚無PD-1或PD-L1抗體被批准用於治療R/R ENKTL,因此我們非常期待擇捷美®造福更多患者。”

據瞭解,GEMSTONE-201研究是一項單臂、多中心的II期註冊性臨牀研究,旨在評價擇捷美®作為單藥治療成人R/R ENKTL的有效性和安全性。該研究在中美兩國同步開展。

值得一提是的擇捷美®於2020年10月被美國FDA授予孤兒藥資格(Orphan Drug Designation, ODD)用於治療T細胞淋巴瘤和突破性療法認定(Breakthrough Therapy Designation, BTD)用於治療成人R/R ENKTL,並被中國國家藥監局審評中心納入“突破性治療藥物”,擬定適應症為復發或難治性結外自然殺傷細胞/T細胞淋巴瘤。

ENKTL屬於成熟T細胞和NK細胞淋巴瘤的一個亞型。R/R ENKTL患者的1年生存率通常不足20%。目前在中國獲批的靶向單藥治療完全緩解率約為6%。一線治療方案失敗後的患者存在顯著的未被滿足的治療需求。

對此,GEMSTONE-201主要研究者、中山大學附屬腫瘤醫院黃慧強教授表示:“R/R ENKTL惡性程度高、侵襲性強。臨牀上一直缺乏有效治療藥物,導致該疾病治癒率低、預後差。此次GEMSTONE-201研究取得成功,表明擇捷美®能夠成為R/R ENKTL患者新的治療選擇,滿足該羣體非常迫切的治療需求。”

經獨立影像評估委員會(IRRC)評估,相較於歷史對照,擇捷美®顯著提高了客觀緩解率(ORR);研究者評估的ORR與IRRC評估結果一致;並且擇捷美®在R/R ENKTL患者中安全性良好,未發現新的安全性信號。

2021年12月21日,中國國家藥品監督管理局(NMPA)已批准潛在同類最優藥物擇捷美®的新藥上市申請,用於聯合化療一線治療鱗狀或非鱗狀IV期非小細胞肺癌患者。此外,2021年9月,NMPA已受理該藥用於同步或序貫放化療後未發生疾病進展的不可切除的III期NSCLC患者鞏固治療的新藥上市申請(NDA)。擇捷美®有望成為全球唯一一個對III期和IV期NSCLC全人羣均具有療效的PD-(L)1抗體。因此業內分析,未來擇捷美®有望成為晚期NSCLC的首選免疫治療藥物。

因此,此次GEMSTONE-201達到主要研究終點也被業內看為擇捷美®新適應症拓展的重要里程碑。據瞭解,除了非小細胞肺癌這個人羣廣泛的大適應症和此次針對淋巴瘤新適應症的佈局,該藥品針對食管鱗癌、胃癌的適應症也正在進行註冊試驗,未來將擁有更大的目標患者人羣。

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