金城醫藥(300233.SZ)：東方略之美國合作方Inovio公佈了VGX-3100項目三期臨牀試驗(Reveal 2)的最新積極數據
格隆匯3月2日丨金城醫藥(300233.SZ)公佈，2023年3月2日公司收到上海仟德通知，其投資的東方略之美國合作方Inovio Pharmaceuticals, Inc. (“Inovio”)公佈了VGX-3100項目三期臨牀試驗(Reveal 2)的最新積極數據。
Reveal 2是在已完成的Reveal 1 (第1次三期臨牀試驗)的基礎上進行的一項全球多中心、隨機、雙盲、安慰劑對照臨牀試驗，是VGX-3100用於上市申請的三期臨牀試驗整體方案Reveal的一部分，用於治療成年女性中高危型HPV-16/18感染相關的宮頸高級別鱗狀上皮內病變(high grade squamous intraepithelial lesion，HSIL)。Reveal 2共入組203名子宮頸鱗狀上皮內瘤變(cervical intraepithelial neoplasia，CIN) 2級和3級患者，其中治療組134名，安慰劑組69名。試驗結果顯示，治療組應答率顯著高於安慰劑組。其中，治療組27.6%(37/134)的參與者達到主要終點(組織病理學轉歸而且病毒清除)，而安慰劑組為8.7%(6/69)，達到了統計學顯著性差異(p=0.001)。尤其在病毒清除方面，治療組的病毒清除率為37.3%(50/134)，而安慰劑組為8.7%(6/69)。
在生物標誌物研究方面，治療前生物標誌物陽性患者一共有25名，在用藥36周後，治療組的應答率為28.6%(6/21)，安慰劑組應答率為0(0/4)，未達到統計學顯著性差異。
彙總分析Reveal 1和Reveal 2兩項三期臨牀試驗數據，VGX-3100在所有研究人羣、生物標誌物陽性患者人羣均達到了統計學上的顯著性差異。在生物標誌物陽性患者中(合計92名參與者，其中治療組68名、安慰劑組24名)，治療組有54.4%(37/68)達到主要終點，而安慰劑組僅為12.5%(3/24)(p<0.001；百分比差異41.9，95%CI：20.4，57.0）。在所有患者人羣中(合計404名，其中治療組272名，安慰劑組132名)，治療組有25.0%(68/272)達到主要終點，而安慰劑組為9.8%(13/132)(p<0.001；百分比差異15.2，95%CI：7.4，22.1)，均達到了統計學顯著性差異。
在安全性方面，VGX-3100具有良好的安全性和耐受性，沒有與治療相關的嚴重不良事件，並能在外周血和宮頸組織中誘導產生抗原特異性的T細胞反應。
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