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先聲藥業(02096.HK)卵巢癌新藥臨床研究達到主要研究終點
阿思達克 01-04 08:21
先聲藥業(02096.HK)公布,注射用蘇維西塔單抗聯合化療(試驗組)對比安慰劑聯合化療(安慰劑組)用於復發性鉑耐藥上皮卵巢癌、輸卵管癌和原發性腹膜癌患者的III期臨床試驗(NCT04908787)(SCORES研究),已達到主要研究終點。 此次結果包括對主要終點無進展生存期(PFS)的最終分析,關鍵次要終點總生存期(OS)的第一次分析及安全性分析。結果顯示SCORES研究達到基於盲態獨立影像評估委員會(BIRC)依據RECIST 1.1標準評估的主要終點PFS:對比安慰劑組,試驗組PFS改善具有統計學意義和臨床意義,且蘇維西塔單抗在所有預設亞組均顯示出一致的PFS臨床獲益。研究者評估的試驗組PFS獲益與BIRC評估獲益相當;OS數據尚未成熟,但試驗組顯示出OS獲益的趨勢;安全性可控,未發現新的安全性信號。本研究結果未來預計在學術期刊或會議上予以公布。 公司計劃於近期向中國國家藥品監督管理局(NMPA)提交註射用蘇維西塔單抗治療鉑耐藥卵巢癌新藥上市申請(NDA)。
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