復宏漢霖(02696.HK)旗下注射液聯合化療臨床研究達主要終點
復宏漢霖(02696.HK)公布,一項比較公司自主開發的漢斯狀(斯魯利單抗注射液)或安慰劑聯合化療一線治療局部晚期或轉移性食管鱗癌(ESCC)患者的3期臨床研究在計劃的期中分析中,經獨立數據監查委員會評估達到無進展生存期(PFS)和總生存期(OS)的雙主要研究終點。
該研究為一項在局部晚期或轉移性食管鱗癌患者中開展的隨機、雙盲、多中心、3期臨床研究,旨在比較漢斯狀或安慰劑聯合化療一線治療局部晚期或轉移性食管鱗癌患者的有效性和安全性。
漢斯狀為公司自主開發的創新型抗PD-1單抗,已於2022年3月獲國家藥品監督管理局批准用於治療經標準治療失敗的、不可切除或轉移性微衛星高度不穩定實體瘤,並計劃用於多種實體瘤治療。
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