君實生物(688180.SH):特瑞普利單抗聯合化療用於晚期三陰性乳腺癌患者治療的III期臨牀研究達到主要研究終點
格隆匯2月20日丨君實生物(688180.SH)公佈,近日,公司產品特瑞普利單抗(商品名:拓益®,產品代號:JS001)聯合注射用紫杉醇(白蛋白結合型)用於首診IV期或復發轉移性三陰性乳腺癌患者治療的隨機、雙盲、安慰劑對照、多中心III期臨牀研究(“TORCHLIGHT研究”,NCT04085276)已完成方案預設的期中分析,獨立數據監查委員會(IDMC)判定研究的主要終點達到方案預設的優效界值。公司將於近期與監管部門溝通遞交該新適應症上市申請事宜。
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