開拓藥業-B(09939.HK)：將於2021年ASCO GI上展示GT90001與Opdivo聯合療法研究結果
格隆匯 12 月 9日丨開拓藥業-B(09939.HK)宣佈，集團於中國台灣就GT90001抗體聯合Nivolumab(Opdivo)抗體二線治療晚期肝細胞癌("HCC")II期臨牀試驗("II期臨牀試驗")獲得積極數據。初步結果顯示，進行中的II期臨牀試驗的療效令人鼓舞且安全性良好。在將於2021年1月15日至17日期間舉行的2021年美國臨牀腫瘤學會胃腸道腫瘤研討會(ASCO GI)上，我們將會公佈II期臨牀試驗收集的數據。
GT90001是一種全人源化單克隆抗體，可抑制ALK-1/TGF-β信號轉導和腫瘤血管生成，且其是我們於2018年2月自輝瑞公司獲得全球獨家授權的潛在同類首創抗體。II期臨牀試驗於2019年5月7日在中國台灣展開，以評估GT90001聯合Nivolumab對一線索拉非尼或侖伐替尼治療後進展或不能耐受的晚期HCC患者的安全性和有效性。
II期臨牀試驗(NCT03893695)是一項單臂、開放式、兩階段的臨牀試驗。其主要觀察GT90001及Nivolumab聯合療法的安全性、耐受性以及抗腫瘤活性。第一階段(安全評估隊列)在GT90001每兩週7mg/kg+Nivolumab每兩週3mg/kg的劑量組中入組6名受試者。第二階段(擴展隊列)在相同劑量水平入組了14名受試者進行聯合治療。根據實體瘤療效評估標準(RECIST)v1.1，受試者接受了治療直至出現病情進展或產生不耐受毒性為止。主要療效終點為研究者評估的客觀緩解率(ORR)。
2019年7月9日至2020年9月30日期間，共20名符合條件的受試者於II期臨牀試驗中接受了治療。結果顯示，在20名可評估受試者中，八名受試者(40.0%)觀察到部分緩解(PR)。副作用耐受性良好且可控。GT90001及Nivolumab的藥物動力學參數與單一療法的藥物動力學參數相似。
完整數據將於ASCOGI上展示。
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