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亞虹醫藥(688176.SH):APL-1202口服聯合替雷利珠單抗新輔助治療肌層浸潤性膀胱癌試驗在2024年美國臨牀腫瘤學會泌尿生殖系統腫瘤研討會上發佈Ⅱ期臨牀試驗期中分析數據
格隆匯 01-28 16:11

格隆匯1月28日丨亞虹醫藥(688176.SH)公佈,公司APL-1202口服聯合替雷利珠單抗作為肌層浸潤性膀胱癌(MIBC)新輔助治療的Ⅰ/Ⅱ期臨牀試驗(以下簡稱“本研究”)Ⅱ期臨牀試驗期中分析結果入選2024年美國臨牀腫瘤學會泌尿生殖系統腫瘤研討會(ASCOGU),並以快速口頭報吿摘要的形式,首次發佈本研究的臨牀數據。

Ⅱ期臨牀試驗的主要目標為評估APL-1202與替雷利珠單抗聯合對比替雷利珠單抗單藥作為新輔助治療在MIBC受試者中的安全性和療效。研究人羣為首次診斷為MIBC並計劃進行根治性膀胱切除術的受試者,不耐受或拒絕接受以順鉑為基礎的新輔助化療的受試者。試驗的主要療效終點為病理完全緩解率。病理完全緩解(pCR):膀胱切除術後對膀胱和淋巴結標本進行組織病理學評估,確認膀胱內無殘留的腫瘤病變和淋巴結轉移。pCR定義為膀胱切除術後組織病理學評估為pT0N0。

Ⅱ期臨牀試驗期中分析結果顯示,APL-1202和替雷利珠單抗聯用治療組,18例可評估療效的受試者中7例達到pCR,為7/18(39%);替雷利珠單抗單藥治療組,14例可評估療效的受試者中3例達到pCR,為3/14(21%)。此外,聯用治療組6例臨牀分期為T3N0M0的受試者中,2例達到pCR,為2/6(33%);替雷利珠單抗單藥治療組臨牀分期為T3N0M0受試者中尚未觀察到pCR。期中分析結果顯示,兩組均達到Simon二階段試驗設計對第一階段療效的要求,將繼續進行下一階段的評估,並對聯合治療組顯示出的更優療效信號進行進一步確認。在安全性方面,聯合治療組顯示出可接受的安全性特徵。

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