基石藥業-B(02616.HK):抗PD-L1抗體在RR-ENKTL患者顯示良好抗腫瘤活性和安全性 完全緩解率達33.3%
格隆匯12月9日丨基石藥業-B(02616.HK)公告,基石藥業於2019年美國血液學會年會上,以海報展示形式發表了CS1001-201研究的最新數據。CS1001-201是一項旨在評價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(rr-ENKTL)的單臂、多中心II期臨牀研究。
結外NK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,且於亞洲的發病率顯着高於歐美。ENKTL病程進展迅速且預後較差。目前,rr-ENKTL患者經含門冬醯胺酶的聯合化療治療失敗後,缺乏標準治療手段,現有的靶向單藥治療完全緩解率不足10%。
基石藥業董事長、執行董事兼首席執行官江寧軍表示:"在中國,ENKTL約佔所有淋巴瘤類型的6%。我們正面臨着這類患者在一線治療方案失敗後的巨大未被滿足的治療需求。最新數據表明,CS1001是目前首個證明在rr-ENKTL患者中耐受良好的,具有初步抗腫瘤療效和生存獲益的抗PD-L1抗體。我們將全力推進這一研究,期待CS1001早日成為rrENKTL患者的治療新選擇。"
基石藥業首席醫學官楊建新表示:"CS1001-201是全球範圍內首個針對ENKTL的抗PD-L1抗體臨牀研究。對於ENKTL治療而言,完全緩解率是一項關鍵預後指標。研究顯示,相比在自體移植前獲得部分緩解的患者,獲得完全緩解的患者可以顯着延長生存期、改善預後。最新研究數據顯示,CS1001的完全緩解率為33.3%且緩解可持續,同時客觀緩解率為43.3%,1年總生存率為72.4%。這些數據相比現有治療選項是一個巨大的突破,並將可能為後續造血幹細胞移植創造良好條件。"
CS1001-201一項旨在評價CS1001單藥治療rr-ENKTL的單臂、多中心、II期臨牀研究。主要目的為考察經過獨立影像評估委員會評估的客觀緩解率。次要目的包括考察經研究者評估的客觀緩解率,經IRRC評估的完全緩解率、部分緩解率、應答時間、緩解持續時間及無進展生存期、總生存期和安全性。
CS1001是由基石藥業開發的在研抗PD-L1單克隆抗體。CS1001由美國公司Ligand PharmaceuticalsInc.(納斯達克股份代號:LGND)授權引進的OMT轉基因動物平台產生,該平台可實現全人源抗體的一站式生產。作為一種全人源全長抗PD-L1單克隆抗體,CS1001是一種最接近人體的天然G型免疫球蛋白4(IgG4)單抗藥物。與同類藥物相比,CS1001在患者體內產生免疫原性及潛在毒性的風險更低,這使得CS1001在安全性方面具有潛在的獨特優勢。CS1001已在中國完成I期研究劑量爬坡。在針對多個適應症的Ia期及Ib期研究中,CS1001表現出良好的耐受性併產出持續的臨牀獲益。目前,CS1001正在進行多項臨牀試驗中,包括一項美國橋接性I期研究。在中國,其臨牀項目包括針對多個癌種的一項多臂Ib期試驗,兩項註冊性II期試驗和三項III期試驗。
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