中生製藥(01177.HK)：派安普利單抗聯合安羅替尼一線治療晚期肝細胞癌的臨試數據摘要獲2020 ASCO年會接受以海報形式呈列
格隆匯5月19日丨中生製藥(01177.HK)宣佈，由集團與康方生物(09926.HK)共同開發及商業化的派安普利單抗(AK105，PD-1單抗)聯合安羅替尼一線治療晚期肝細胞癌的臨牀療效和安全性二期研究數據摘要，已獲即將召開的2020年美國臨牀腫瘤學會(ASCO)年會接受以海報形式呈列。
此次將在ASCO發佈的研究數據涉及的研究分為Ib/II期研究，為派安普利(200mg Q3W)聯合鹽酸安羅替尼8mg，每日一次，連續2周停1周(n=31)。腫瘤緩解情況評估使用的是1.1版的實體瘤療效評估標準。
臨牀研究數據顯示(截至2020年1月14日)：
1. 安全性：聯合治療耐受性好，未出現治療相關的嚴重不良事件。大多數治療相關不良事件(TRAE)為1-2級別，≥3級TRAE發生率為12.9％，其中僅1例患者(3.2%)發生了3級高血壓，僅有1例患者(3.2%)因治療相關的不良事件停止治療。
2. 腫瘤反應評價：至數據截止時，在可至少進行過2次影像學評估的25例患者中，確認的客觀緩解率(ORR)為24％，疾病控制率(DCR)為84%。部分患者治療持續時間最長已達11個月，仍繼續接受治療。
3. 臨牀療效：至數據截止時，在入組給藥31例患者，中位隨訪時間為7.0個月，中位至疾病進展時間為8.8個月，6個月時無疾病進展率為59.8%(95%置信區間：35.1%，77.6%)，中位總生存期尚未達到，6個月時的總生存率為91.6%(95%置信區間：69.9%，97.9%)。
截至目前，派安普利單抗已啟動多項與安羅替尼聯合治療的II/III期臨牀試驗，涉及的癌種包括非鱗非小細胞肺癌(non-squamous NSCLC)、胃癌(GC)、食管鱗癌(ESCC)、肝癌(HCC)、泌尿上皮癌(UC)、頭頸部癌(HNC)、MSI-H或dMMR實體瘤、神經內分泌瘤(NET)等多個重要癌種。
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