澤璟製藥(688266.SH):將於EHA大會口頭公佈鹽酸傑克替尼片治療中、高危骨髓纖維化II期臨牀試驗數據
格隆匯6月10日丨澤璟製藥(688266.SH)披露,公司的1類新藥鹽酸傑克替尼片治療中、高危骨髓纖維化的II期臨牀研究(ZGJAK002)取得成功,併入選2021年歐洲血液學協會年會(2021EHA)的口頭報吿。該研究主要研究者浙江大學第一附屬醫院血液科金潔教授將於2021年6月11日上午9點(歐洲中部時間)在EHA大會上口頭報吿該研究詳細數據。
在此項開放、隨機、多中心的Ⅱ期臨牀試驗(ZGJAK002)中,共計入組104例中、高危骨髓纖維化患者,按1:1隨機分為兩組(ITT集,兩組各52例),分別口服鹽酸傑克替尼片100mg每日兩次(BID)或200mg每日一次(QD)。結果顯示,鹽酸傑克替尼片治療24周,100mg BID組和200mg QD組脾臟體積縮小≥35%(SVR35)的比例分別為51.9%和30.8%,組間差異有統計學意義(p=0.0459)。治療24周後,兩組合計的TSS評分降低≥50%的患者比例100mg BID組和200mg QD組的比例分別為57.7%和53.8%,患者生活質量得到了改善。
鹽酸傑克替尼片可改善貧血,升高血紅蛋白,並減少輸血依賴。鹽酸傑克替尼片在中國中、高危骨髓纖維化患者中是安全和耐受的。目前,鹽酸傑克替尼片治療中、高危骨髓纖維化的III期臨牀試驗正在開展中,治療劑量為100mgBID。
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