澤璟製藥(688266.SH):發佈甲苯磺酸多納非尼片臨牀試驗數據摘要
格隆匯5月14日丨澤璟製藥(688266.SH)公佈,公司國家1類新藥甲苯磺酸多納非尼片(“多納非尼”)新藥上市申請(NDA)已獲國家藥品監督管理局(NMPA)正式受理,詳見公司2020年5月12日披露的《關於獲得新藥上市申請註冊受理通知書的公告》。
2020年美國臨牀腫瘤學會年會(2020 ASCO Annual Meeting)將於2020年5月29日至2020年6月2日舉行,公司“多納非尼對比索拉非尼一線治療晚期肝細胞癌(HCC)的開放標籤、隨機對照、多中心II/III期臨牀研究(ZGDH3試驗)摘要”入選2020 ASCO 年會的口頭報告。ZGDH3試驗的結果於5月13日(美國時間)在ASCO官網上摘要發表,而詳細數據將於ASCO大會期間進行口頭報告公佈。
以上事項對公司近期業績不會產生重大影響,藥品研發過程容易受到一些不確定性因素的影響,敬請廣大投資者謹慎決策,注意防範投資風險。
ZGDH3試驗結果摘要:
方法:在這項開放標籤、隨機的II/III期臨牀試驗(ZGDH3)中,中國37家研究中心招募Child-Pugh肝功能評分7且既往未接受過系統治療的、不可手術或轉移性HCC患者,按照1:1的比例隨機分組,分別口服多納非尼(0.2g)或索拉非尼(0.4g),每日兩次,直至發生不可耐受的毒性或疾病進展。主要研究終點為總生存期(OS),有效性的主分析集為全分析集(FAS)。
結果:2016 年3月至2018年4月,共入組668例患者(ITT集,兩組各334例),其中659例(328例vs331例)納入FAS集。結果顯示,多納非尼組和索拉非尼組的中位OS,在FAS集分別為12.1個月和10.3個月(風險比HR 0.831,95%置信區間CI0.699–0.988,p= 0.0363),在ITT集分別為12.0個月和10.1個月(HR0.839,95% CI 0.706–0.996,p= 0.0446),多納非尼組顯著優於索拉非尼組。兩組的中位無進展生存期(3.7個月vs 3.6個月,p= 0.2824)、客觀緩解率(4.6% vs 2.7%,p= 0.2448) 和疾病控制率(30.8% vs28.7%,p= 0.5532) 均無顯著差異。兩組分別有191例(57.4%) 和224例(67.5%)發生≥3 級的不良事件(AE) (p= 0.0082);重要不良事件分別為287例(86.2%) 和309 例(93.1%,p= 0.0049),導致暫停用藥的AE分別為101 例(30.3%) 和141 例(42.5%,p= 0.0013) ,多納非尼組均顯著低於索拉非尼組。此外,多納非尼組發生嚴重AE的例數相對較少(55 [16.5%] vs67 [20.2%],p= 0.2307)。多納非尼組最常發生的AE為手足皮膚反應(50.5%)、AST升高(40.5%)、血膽紅素升高(39.0%)、血小板降低(37.8%) 和腹瀉(36.6%)。
結論:與索拉非尼相比,多納非尼能夠延長晚期HCC患者的總生存期(OS), 具有統計學顯著性。並且具有更好的安全性和耐受性,有望成為一線優選治療。
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