百濟神州(06160.HK)：百澤安®聯合化療治療一線晚期食管鱗狀細胞癌的全球3期臨牀試驗達到主要終點
格隆匯4月27日丨百濟神州(06160.HK)公吿，於2022年4月27日宣佈，根據獨立數據監查委員會(IDMC)在預先設定的期中分析中評估，一項百澤安®聯合化療針對既往未經治療的晚期或轉移性食管鱗狀細胞癌(ESCC)患者的全球3期臨牀試驗RATIONALE306已達到總生存期(OS)的主要終點。該期中分析中，百澤安®聯合化療的安全性和耐受性特徵與既往試驗一致，未發現新的安全性警示。
"ESCC作為一類難以治癒的疾病，給患者帶來了沉重的負擔。在RATIONALE306臨牀試驗中，百澤安®聯合化療顯示出生存獲益令公司無比振奮。公司設計了覆蓋全球的拓展性臨牀開發專案來探索百澤安®治療實體瘤的潛力。此次研究是百澤安®第7項取得積極結果的3期關鍵性試驗，驗證了百澤安®的治療獲益，對公司來説意義深遠。"百濟神州實體瘤首席醫學官MarkLanasa醫學表示，"此前在RATIONALE302臨牀試驗中，公司評估了百澤安®對比化療，作為二線治療方案對於ESCC患者的效果，並觀察到總生存期獲益，而本次RATIONALE306研究的結果再次擴充了公司的臨牀證據，進一步驗證了百澤安®作為ESCC標準治療方案的潛力。公司由衷感謝參與這兩項關鍵性3期研究的1,100多位ESCC患者，並期待在未來的學術會議上與業界同仁共用RATIONALE306的研究結果。"
百澤安®用於治療既往化療後的晚期或轉移性ESCC的新藥上市申請已獲得美國食品藥品監督管理局(FDA)和歐洲藥品管理局(EMA)的受理，目前正在審評過程中。此外，百澤安®治療既往接受化療後的晚期或轉移性非小細胞肺癌(NSCLC)，以及與化療聯合用藥治療既往未經治療的晚期或轉移性NSCLC的申請也已獲EMA受理，目前正在審評中。2021年1月，百濟神州宣佈與諾華達成合作，授權諾華在北美、歐洲和日本開發、生產和商業化百澤安®。
百澤安®已獲中國國家藥品監督管理局(NMPA)批准用於八項適應症的治療，包括最近獲批用於既往接受過一線標準化療後進展或不可耐受的局部晚期或轉移性ESCC患者。目前，百澤安®在中國以外國家或地區尚未獲批。
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