康方生物-B(09926.HK):卡度尼利聯合同步放化療治療局部晚期宮頸癌III期臨牀研究獲批開展
格隆匯1月4日丨康方生物-B(09926.HK)發佈公吿,公司自主研發的全球首創新型腫瘤免疫治療新藥卡度尼利(PD-1/CTLA-4雙特異性抗體,研發代號:AK104)獲得中國國家藥品監督管理局藥品審評中心(“CDE”)批准,開展聯合同步放化療治療局部晚期宮頸癌的III期臨牀研究。這是中國首個針對局部晚期宮頸癌免疫療法的III期臨牀研究。
該臨牀研究是一項隨機、雙盲、多中心、安慰劑對照的III期臨牀研究,旨在評估對於局部晚期宮頸癌患者,卡度尼利聯合同步放化療對照安慰劑聯合同步放化療的有效性和安全性。
基於卡度尼利在復發╱轉移宮頸癌臨牀研究中獲得的積極效應,CDE於2021年9月已經受理卡度尼利治療復發╱轉移宮頸癌的新藥上市申請,並給予優先審評資格。卡度尼利也因此有望成為全球首個批准上市的基於PD-1的雙特異性抗體。另外,2021年5月,卡度尼利加含鉑化療聯合╱不聯合貝伐珠單抗一線治療持續、復發或轉移性宮頸癌的全球III期臨牀研究也已經開展。這是中國首個一線宮頸癌雙特異性抗體免疫療法的III期臨牀研究。
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