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康寧傑瑞製藥-B(09966.HK):將在SITC 2020以海報展示KN026及KN046聯合療法初步正面結果摘要
格隆匯 11-10 07:34

格隆匯 11 月 10日丨康寧傑瑞製藥-B(09966.HK)發佈公告,KN026(一種重組人源化抗HER2雙特異性抗體)及KN046(一種重組人源化PD-L1/CTLA-4雙特異性抗體)的聯合療法(“KN026+KN046聯合療法”)已於針對標準治療失敗的HER2陽性實體瘤患者的Ib期臨牀試驗取得初步正面結果。相關臨牀數據的摘要已獲准於即將舉行的第35屆癌症免疫治療學會年會(“SITC 2020”)以海報展示,該年會今年將在線上舉行。摘要將於2020年11月9日上午八時正(美國東岸時間)發佈,而電子海報將於2020年11月11日上午九時正至 2020年11月14日下午五時正(美國東岸時間)在線上展示,並均可於公司網站www.alphamabonc.com閲覽。

根據披露,Ib期臨牀試驗為一項劑量遞增和劑量擴展、開放式標籤、多中心臨牀研究,目的為評估KN026+KN046聯合療法用於治療標準治療失敗的HER2陽性實體瘤患者的初步安全性、耐受性及有效性結果。截至2020年9月8日,共入組25名消化道腫瘤患者並接受三個劑量組KN026+KN046聯合療法治療。臨牀數據顯示KN026+KN046聯合療法耐受性良好,且未觀察到劑量限制性毒性。

基於令人鼓舞的療效數據,KN026+KN046 聯合療法的註冊臨牀試驗(“SEARCH-01”)即將啟動。SEARCH-01計劃在中國20至30家和在美國10至20家臨牀研究中心開展,以評估聯合療法治療HER2陽性實體瘤,包括HER2陽性GC/ GEJ╱食管腺癌的有效性、安全性和耐受性。 

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