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君實生物(01877.HK):特瑞普利單抗聯合化療一線治療非鱗狀非小細胞肺癌的新適應症上市申請獲得批准

格隆匯9月20日丨君實生物(01877.HK)公吿,公司收到國家藥品監督管理局核准簽發的《藥品註冊證書》,特瑞普利單抗(商品名:拓益,產品代號:JS001)聯合培美曲塞和鉑類適用於表皮生長因子受體(EGFR)基因突變陰性和間變性淋巴瘤激酶(ALK)陰性、不可手術切除的局部晚期或轉移性非鱗狀非小細胞肺癌(NSCLC)的一線治療的新適應症上市申請獲得批准。

肺癌是目前全球發病率第二、死亡率第一的惡性腫瘤,在中國的發病率和死亡率亦位列第一。根據世界衞生組織發佈的數據,2020年中國新發肺癌病例數為81.6萬,佔中國新發癌症病例數的17.9%,2020年中國肺癌死亡病例數為71.5萬,佔中國癌症死亡病例數的23.8%。非小細胞肺癌為肺癌的主要亞型,約佔所有病例的85%。在非小細胞肺癌中非鱗狀非小細胞肺癌患者佔比約70%。現有國內外研究表明,抗PD-(L)1單抗單藥或聯合化療已成為一線晚期驅動基因陰性非小細胞肺癌的新標準治療。

本次新適應症的獲批主要基於CHOICE-01研究(NCT03856411),是一項隨機、雙盲、安慰劑平行對照、多中心III期臨牀研究,由中國醫學科學院腫瘤醫院王潔教授擔任主要研究者。自2019年4月2日至2020年8月5日,CHOICE-01研究在全國63家中心共入組了465例非小細胞肺癌患者,其中245例非鱗狀非小細胞肺癌患者按照2:1隨機入組,接受特瑞普利單抗╱安慰劑聯合培美曲塞和順鉑╱卡鉑治療。疾病進展後,符合條件的對照組受試者可接受特瑞普利單抗單藥的交叉治療。

此前,CHOICE-01研究在2022年美國臨牀腫瘤學會(ASCO)全體大會系列3月會議以及ASCO年會上公佈了最新研究成果。研究數據顯示,與單純化療方案相比,特瑞普利單抗聯合化療一線治療無EGFR/ALK突變的晚期非小細胞肺癌患者可顯着延長其無進展生存期(PFS)和總生存期(OS),患者療效不受PD-L1表達的影響,且安全性可管理。截至2021年10月31日,在245例非鱗狀非小細胞肺癌患者中,特瑞普利單抗聯合化療組的中位PFS達到9.7個月,比安慰劑聯合化療組延長4.2個月(HR=0.48[95%CI:0.35-0.66],p<0.0001);特瑞普利單抗聯合化療組的中位OS仍未達到,已觀察到其總生存獲益,可降低52%的死亡風險(HR=0.48[95%CI:0.32-0.71])。

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