和黃醫藥(00013.HK)與阿斯利康啟動沃瑞沙®(ORPATHYS®)治療MET擴增胃癌患者II期臨試
格隆匯7月28日丨和黃醫藥(00013.HK)發佈公吿,和黃醫藥與阿斯利康(LSE/STO/Nasdaq: AZN)已啟動一項沃瑞沙®(通用名:賽沃替尼/Savolitinib;英文商品名:ORPATHYS®)的II期臨牀試驗。沃瑞沙®是一種強效、高選擇性的口服小分子間質上皮轉化因子(“MET”,一種受體酪氨酸激酶)抑制劑,用於治療MET擴增的晚期或轉移性胃癌或胃食管結合部腺癌患者。首名患者已於2021年7月27日接受給藥治療。
該項II期研究是一項開放標籤及兩隊列的多中心臨牀試驗,旨在評估沃瑞沙®在至少接受過一線標準治療後疾病進展的局部晚期或轉移性胃癌或胃食管結合部腺癌患者中的療效、安全性和藥代動力學特徵。研究的主要終點是獨立審查委員會評估的客觀緩解率(“ORR”)。其他終點包括12周和6個月的無進展生存(“PFS”)率、中位PFS、緩解持續時間(“DoR”)、疾病控制率(“DCR”)、中位總生存期(“OS”)、安全性、藥代動力學特徵以及生活質量。
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