百濟神州(688235.SH)在2022年歐洲腫瘤內科學會世界胃腸癌大會上展示百澤安®(替雷利珠單抗注射液)最新數據
格隆匯6月30日丨百濟神州(688235.SH)公佈，公司在2022年歐洲腫瘤內科學會(ESMO)世界胃腸癌大會上公佈全球3期臨牀試驗RATIONALE306的最新數據，展示百澤安®(替雷利珠單抗注射液)聯合化療治療既往未接受過晚期疾病全身治療的晚期或轉移性食管鱗狀細胞癌成人患者的效果。
在2022年歐洲腫瘤內科學會(ESMO)世界胃腸癌大會(摘要#LBA-1)上，公司口頭報吿了全球3期臨牀試驗RATIONALE 306的最新數據。數據結果顯示接受百澤安®聯合化療的患者總生存期(OS)取得統計學顯著性和臨牀意義的改善，中位OS為17.2個月[95%置信區間(CI)：15.8~20.1]，而接受安慰劑聯合化療的患者的中位OS為10.6個月[95%CI：9.3~12.1]。與安慰劑聯合化療相比，百澤安®聯合化療使患者死亡風險降低34%(分層風險比(HR)=0.66[95%CI：0.54~0.80，p值<0.0001])。
百澤安®是一款人源化IgG4抗程序性死亡受體-1(PD-1)單克隆抗體，設計目的是為最大限度地減少與巨噬細胞中的Fcγ受體結合，幫助人體免疫細胞檢測和對抗腫瘤細胞。臨牀前數據表明，巨噬細胞中的Fcγ受體結合之後會激活抗體依賴細胞介導殺傷T細胞，從而降低了PD-1抗體的抗腫瘤活性。百澤安®是第一款由公司的免疫腫瘤生物平台研發的藥物，目前正進行單藥及聯合療法臨牀試驗，以開發一系列針對實體瘤和血液腫瘤的廣泛適應症。
RATIONALE 306是一項隨機、安慰劑對照、雙盲、全球性的3期臨牀試驗(NCT03783442)，旨在評估百澤安®聯合化療，作為晚期或轉移性ESCC患者一線治療的有效性和安全性。該試驗的主要終點為總生存期(OS)。次要終點包括根據RECIST1.1版評估的無進展生存期、總緩解率、緩解持續時間、PD-L1評分≥10%患者亞組的OS，以及健康相關生活質量指標和安全性。
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