基石藥業-B(02616.HK)：舒格利單抗治療R/R ENKTL臨牀研究(CS1001-201)通過美國FDA試驗性新藥審評
格隆匯 8 月 31日丨基石藥業-B(02616.HK)發佈公告，基石藥業PD-L1抗體舒格利單抗(CS1001)單藥治療復發或難治性結外自然殺傷細胞(“NK”)/T細胞淋巴瘤(“R/R ENKTL”)的試驗性新藥(“IND”)申請已經通過美國食品藥品監督管理局(“FDA”)的審評，並取得了開展研究的許可函。
舒格利單抗是由基石藥業開發的全人源全長抗PD-L1單克隆抗體。與同類藥物相比，舒格利單抗的免疫原性以及在患者體內產生相關毒性的風險更低。CS1001-201研究是一項CS1001單藥治療R/R ENKTL的單臂、多中心、關鍵性II期研究。本次IND申請通過審評，意味着正在中國國內開展的CS1001-201研究將擴展至美國。
根據披露，ENKTL屬於成熟T和NK細胞淋巴瘤的一個亞型，其分佈具有區域特徵性，亞洲發病率顯着高於歐洲及北美。在中國，ENKTL約佔所有淋巴瘤的6%。R/R ENKTL惡性程度高且侵襲性強，預後較差。R/R ENKTL患者在含門冬醯胺酶為基礎的標準方案失敗後，缺乏有效的挽救治療手段,對傳統治療反應不佳。臨牀醫生對於這類患者常常束手無策，因為疾病兇險，進展迅速，生存期極短，一年總生存率(“OS”)不足20%。目前在中國獲批的靶向單藥治療完全緩解率(“CR”)約為6%。一線治療方案失敗後的患者正面臨着巨大的未被滿足的治療需求，舒格利單抗有望為這些患者提供新的治療選擇。
基石藥業首席醫學官楊建新博士表示：“對於ENKTL治療而言，CR是一項關鍵預後指標。在2019年ASH會議上針對CS1001-201研究資料顯示，舒格利單抗的CR率高達33.3%且緩解可持續，同時客觀緩解率(“ORR”)達43.3%，1年OS率為72.4%。相比現有治療方案是一個巨大的突破，並將支持舒格利單抗可能為後續造血幹細胞移植達到治癒創造潛在條件。我們將繼續全力推進該研究，並與美國FDA和中國國家藥品監督管理局(“NMPA”)密切協作，務求早日把舒格利單抗帶給全球R/R ENKTL患者。”
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