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信達生物(01801.HK):達伯舒®聯合達攸同®及化療用於治療EGFR-TKI治療失敗的EGFR突變非鱗狀非小細胞肺癌隨機、雙盲III期臨牀研究達到主要研究終點
格隆匯 10-18 07:30

格隆匯10月18日丨信達生物(01801.HK)發佈公吿,由信達生物與禮來製藥聯合開發的創新藥物PD-1抑制劑達伯®(信迪利單抗注射液)聯合達攸®(貝伐珠單抗注射液)及化療用於表皮生長因子受體酪氨酸激酶抑制劑(“EGFR-TKI”)治療失敗的EGFR突變非鱗狀非小細胞肺癌(“nsqNSCLC”)的一項隨機、雙盲、多中心III期臨牀研究(研究代號:ORIENT-31)第一次期中分析達到主要研究終點。

這是全球首個證實PD-1抑制劑聯合抗血管藥物(即達伯舒®信迪利單抗注射液加達攸同®貝伐珠單抗注射液)以及化療在EGFR-TKI治療進展的EGFR突變nsqNSCLC人羣中顯著提高無進展生存期(PFS)的前瞻性、雙盲、多中心III期研究。

根據披露,肺癌是全球及中國死亡率最高的惡性腫瘤。中國肺癌患者中EGFR突變的比例高達40%至50%,經過一、二、三代EGFR-TKI治療失敗的肺癌患者含鉑化療是目前指南推薦的標準治療,但療效有限,臨牀上迫切需要新的治療選擇,存在巨大的未滿足的臨牀需求。公司期待達伯舒®聯合達攸同®聯合化療這一新的治療方案為EGFR-TKI治療進展的EGFR突變的nsqNSCLC患者帶來新的更有效的治療選擇。

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