次新異動 | 開拓藥業盤中大漲18%，治療晚期肝癌藥品數據亮眼
uSMART盈立智投12月10日消息，次新股開拓藥業早盤高開並急速拉昇，截至發稿，最高報9.44港元，漲幅18%。
消息面上，開拓藥業ALK抗體+Opdivo二線治療晚期肝癌數據亮眼，客觀緩解率達40%。
12月9日，開拓藥業宣佈其將在2021年美國臨牀腫瘤學會胃腸道腫瘤研討會(ASCO GI)上通過海報(Poster)的方式公佈ALK-1抗體GT90001聯合PD-1抗體Nivolumab二線治療晚期肝細胞癌(HCC)患者II期試驗的積極數據。結果顯示，聯合療法的療效令人鼓舞且安全性良好。2021年ASCO GI將於當地時間2021年1月15日-17日舉行。
GT90001爲ALK-1（Activin Receptor-Like Kinase-1，活化素受體樣激酶-1）全人源單克隆抗體，開拓藥業於2018年自輝瑞獲得該藥物全球獨家開發、生產和商業化的權利。ALK-1抗體可通過阻斷ALK-1受體通路來抑制腫瘤血管生長、減少血流及血管生成，從而減緩腫瘤生長，亦可改變腫瘤微環境。GT90001作爲全球潛在first-in-class創新藥物，有望用於多種實體腫瘤的治療。
開拓藥業2019年5月7日在臺灣啓動GT90001聯合Nivolumab（PD-1抗體）用於治療晚期肝癌的II期臨牀試驗，旨在評估GT90001聯合Nivolumab（O藥）對一線索拉非尼或侖伐替尼治療後進展的晚期HCC患者的安全性和有效性。
這是一項單臂、開放式、兩階段的臨牀試驗。試驗主要觀察聯合療法的安全性、耐受性以及抗腫瘤活性。第一階段（安全評估隊列）以GT90001 每2周7mg/kg+Nivolumab每2周3mg/kg的劑量入組6例受試者。第二階段（擴展隊列）入組14例受試者使用相同劑量進行聯合治療。根據RECIST v1.1，受試者接受治療直到失去臨牀療效或出現不可耐受的毒性，主要療效終點爲研究者評估的客觀緩解率（ORR）。
結果顯示：2019年7月9日至2020年9月30日，在20例可評估的患者中，有8例患者觀察到部分緩解（PR），客觀緩解率達到40%，且安全性良好。GT90001和Nivolumab的藥代動力學參數與單藥治療相似。
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