和黃醫藥(00013.HK)與阿斯利康啟動賽沃替尼與英飛凡®聯合治療MET驅動的晚期乳頭狀腎細胞癌患者的SAMETA國際III期臨牀試驗
格隆匯11月1日丨和黃醫藥(00013.HK)宣佈,公司與阿斯利康已啟動SAMETA研究。SAMETA是一項全球III期臨牀試驗,旨在研究強效、高選擇性的口服間質上皮轉化因子(MET,一種受體酪氨酸激酶)小分子抑制劑賽沃替尼(中國商品名:沃瑞沙®/ORPATHYS®)與阿斯利康的PD-L1抑制劑英飛凡®(通用名:度伐利尤單抗/durvalumab)聯合療法用於治療MET驅動的乳頭狀腎細胞癌患者。首名患者已於2021年10月28日接受首次給藥治療。
該項III期研究是在未接受治療的的MET驅動的無法手術切除的局部晚期或轉移性乳頭狀腎細胞癌中開展的開放標籤、隨機對照的多中心臨牀試驗。該研究將評估賽沃替尼與英飛凡®聯合療法對比英飛凡®單藥療法或索坦®(sunitinib,一種口服多激酶抑制劑,目前被認為是此類患者的標準療法)單藥療法的療效及安全性。研究的主要終點是中位無進展生存期(PFS)。其他終點包括中位總生存期(OS)、客觀緩解率(ORR)、緩解持續時間(DoR)、6個月和12個月的疾病控制率(DCR)、第二次無進展生存期(PFS2)、安全性、藥代動力學及生存質量。
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