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康方生物-B(09926.HK):卡度尼利聯合多西他賽治療PD-1/L1經治晚期NSCLC的II期臨牀獲批開展
格隆匯 03-08 06:14

格隆匯3月8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)獲得國家藥品監督管理局藥品審評中心(CDE)批准,開展聯合多西他賽在PD-1/L1抑制劑和含鉑雙藥化療治療失敗的晚期非小細胞肺癌患者中的II期臨牀研究,該研究為一項開放性、多中心的II期臨牀研究。

PD-1/L1抑制劑聯合化療已成為晚期非小細胞肺癌(NSCLC)的一線標準治療,但超過70%的患者在一線PD-1/L1抑制劑聯合治療1年後發生疾病進展。對於一線免疫治療聯合化療治療後疾病進展的NSCLC患者,標準治療為多西他賽單藥,無進展生存期約為4個月,總生存期約10個月。為提高PD-1/L1抑制劑單藥或聯合化療治療失敗後患者的生存預後,臨牀極需能夠迭代的治療手段。

卡度尼利是同時靶向PD-1和CTLA-4的雙特異性抗體,聯合多西他賽,可能可以彌補免疫療法起效慢、假性進展等不足,在PD-1/L1抑制劑和含鉑雙藥化療治療失敗的NSCLC患者中取得良好療效。

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