石藥集團(01093.HK):CPO301獲美國FDA授予快速通道資格
格隆匯6月12日丨石藥集團(01093.HK)發佈公吿,集團開發的用於治療復發╱難治性或EGFR靶向治療(如第三代EGFR抑制劑,包括奧希替尼)無效的轉移性EGFR突變非小細胞肺癌患者的同類首創抗體藥物偶聯物CPO301,獲得美國食品藥品監督管理局(FDA)授予快速通道資格。
肺癌是世界上發病率和死亡率最高的惡性腫瘤之一,估計全球每年有超過220萬人診斷患有肺癌,及超過170萬人死於肺癌。EGFR激活突變是肺癌的主要驅動因素之一,亦是眾多已批准的EGFR酪氨酸激酶抑制劑(TKI)的靶點,包括第一代、第二代和第三代TKI(如奧希替尼)。然而經TKI治療後新突變的出現帶來了治療上的挑戰,高達約25%的非小細胞肺癌患者在接受奧希替尼治療後出現新的突變,除挽救性化療外並無其他有效的治療方法。
臨牀前研究顯示,CPO301呈劑量依賴性地抑制免疫缺陷小鼠中具有各種EGFR激活突變或野生型EGFR高表達的人類腫瘤的生長。CPO301尤其在含有針對第三代EGFR-TKI奧希替尼耐藥的EGFR三重突變(Exon19Del、T790M及C797S)的人源化非小細胞肺癌PDX模型中顯示出很強的抗腫瘤效果。臨牀前毒理學和安全藥理學研究中已顯示良好的安全性和耐受性。
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