百濟神州(06160.HK)在AACR 2021年年會公佈Sitravatinib聯合百澤安®臨牀數據
格隆匯 4 月 12日丨百濟神州(06160.HK)於2021年4月11日(美國東部時間)在美國癌症研究協會(AACR)2021年年會上的兩項口頭報吿中公佈了其抗PD-1抗體百澤安® (替雷利珠單抗)聯合與Mirati Therapeutics, Inc. 合作開發的在研選擇性激酶抑制劑sitravatinib的臨牀數據。在年會上公佈的數據來自一項1b期臨牀試驗 (NCT03666143)的兩個佇列，分別用於治療PD-1/PD-L1療法難治性或耐藥性的不可切除或轉移性黑色素瘤患者以及用於治療晚期鉑類耐藥卵巢癌(PROC)患者。
百濟神州先前與Mirati Therapeutics, Inc. 達成獨家合作和授權協定，在亞洲(不包括日本)、澳大利亞和紐西蘭共同開發、生產和商業化sitravatinib。
百濟神州腫瘤免疫學首席醫學官賁勇醫學博士表示：“從今天公佈的數據來看，我們認為sitravatinib聯合百澤安®有望為晚期實體瘤患者提供臨牀益處，並支持我們在正在開展的臨牀試驗中進一步評估這項組合用藥。此外，我們很興奮地在PD-1/ PD-L1療法難治性或耐藥性黑色素瘤患者中觀察到了初步抗腫瘤活性。我們將繼續對患者進行隨訪並完成試驗的全部患者入組，也期待同時不斷加深對該組合用藥的認知，為世界各地的患者提供一款新型抗擊癌症的療法。”
這項開放性、多中心的1b期臨牀試驗旨在評估sitravatinib聯合百澤安®針對晚期實體瘤患者的安全性╱耐受性和初步抗腫瘤活性。試驗的主要終點為該項組合用藥的安全性╱耐受性；關鍵次要終點包括經研究者基於實體瘤療效評價標準(RECIST 1.1)評估的客觀緩解率(ORR)、疾病控制率(DCR)和無進展生存期 (PFS)。此外，該試驗也對總生存期(OS)進行評估。
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