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宜明昂科-B(01541.HK)預計2025年第三季在中國完成IMM2510/AXN-2510聯合化療治療一線NSCLC患者2期試驗約60名患者入組

宜明昂科-B(01541.HK)公告,公司連同InstilBio,Inc.欣然宣佈,有關IMM2510/AXN-2510的臨牀最新情況及未來計劃如下:

IMM2510/AXN-2510聯合化療治療一線非小細胞肺癌(NSCLC)的2期試驗

預計將於2025年第三季度在中國完成IMM2510/AXN-2510聯合化療治療一線NSCLC患者的2期試驗的約60名患者入組。自2025年3月底以來,在已入組的30多名NSCLC患者中(包括安全性導入期),有20多名一線NSCLC患者已接受治療。此2期試驗的初步安全性及有效性結果預計將於2025年下半年公佈。

IMM2510/AXN-2510單藥治療複發性╱難治性NSCLC的數據(中國)

客觀響應率(ORR)與競爭對手處於類似開發階段的PD-(L)1x血管內皮生長因子(VEGF)雙特異性抗體的數據集相似,均爲針對既往接受過治療的NSCLC患者,ORR爲23%(可評估有效性n=13)。

有關IMM2510/AXN-2510的其他臨牀及臨牀前最新情況

公司預計於2026年年中在中國啓動IMM2510/AXN-2510聯合化療治療一線NSCLC的3期試驗,目前尚待與監管部門商討。臨牀前實驗證明,IMM2510/AXN-2510在體外存在VEGF時能與PD-L1協同結合。有關IMM2510/AXN-2510顯示出獨特且可能是同類最佳作用機制的更多臨牀前數據集,預計將在未來的醫學或科學會議上公佈。

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