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康方生物-B(09926.HK):派安普利單抗(PD-1)聯合安羅替尼一線治療晚期肝癌的最新研究在2021 ASCOGI上發佈
格隆匯 01-20 06:34

格隆匯 1 月 20日丨康方生物-B(09926.HK)發佈公吿,公司與中國生物製藥(01177.HK)共同開發的抗PD-1單抗藥物派安普利(安尼可)(研發代號:AK105)聯合安羅替尼一線治療晚期肝癌(“HCC”)的最新研究在2021年國際胃腸道癌症研討會(“2021 ASCOGI”)上發佈。

截至2020年11月,派安普利聯合低劑量安羅替尼(8毫克,連續兩週,停藥一週)一綫治療HCC的確認客觀緩解率(ORR)為31.0%,疾病控制率(DCR)為82.8%,中位無進展生存期(“PFS”)為8.8個月,6個月PFS率為63.2%,未達到中位生存期(“OS”),6個月OS率為93.2%。與派安普利或安羅替尼相關的3級及以上的不良事件(TRAE)發生率為19.4%,與派安普利或安羅替尼相關的嚴重不良事件發生率為6.5%。

研究認為,派安普利聯合安羅替尼組合安全耐受,作為晚期HCC患者的一線治療表現出令人鼓舞的抗腫瘤活性。同時,研究結果支持探索更高劑量的安羅替尼與派安普利聯合,派安普利聯合安羅替尼(10毫克,連續服藥兩週,停藥一週)一綫治療晚期HCC的III期臨牀試驗(NCT04344158)正在進行中。

2020年5月,派安普利用於治療至少經過二線系統化療復發或難治性經典型霍奇金淋巴瘤(r/rcHL)的新藥上市申請已經獲得國家藥品監督管理局(NMPA)受理。派安普利三線治療轉移性鼻咽癌註冊性臨牀試驗也達到由獨立影像評估的客觀緩解率(ORR)主要終點。目前派安普利佈局的主要適應症包括肝癌、胃癌、肺癌等疾病,也開展多項派安普利聯合安羅替尼在多個瘤種的臨牀試驗。

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