翰森製藥(03692.HK):阿美樂聯合化療治療EGFR突變局部晚期或轉移性非小細胞肺癌III期臨牀試驗達到主要研究終點
格隆匯10月22日丨翰森製藥(03692.HK)公吿,評估阿美樂聯合化療作為局部晚期(IIIB~IIIC期)或轉移性(IV期)表皮生長因子受體(EGFR)突變非小細胞肺癌(NSCLC)一線治療方案的III期註冊試驗AENEAS2達到其主要研究終點即無進展生存期(PFS)。
阿美樂聯合化療在EGFR突變的晚期肺癌患者中顯示出的PFS改善具有統計學顯著性和臨牀意義。該研究詳細結果將於未來醫學會議發佈及向監管機構遞交。阿美樂(甲磺酸阿美替尼片)是中國首個原研的三代EGFR-TKI類創新藥。2020年三月,阿美樂獲批用於既往經EGFR-TKI治療進展且T790M突變陽性的局部晚期或轉移性NSCLC患者,並已於2023年一月成功續約納入2022版國家醫保目錄。2021年12月,阿美樂獲批用於具有EGFR外顯子19缺失或外顯子21(L858R)置換突變陽性的局部晚期或轉移性NSCLC成人患者的一線治療,並於2023年一月被納入2022版國家醫保目錄。2024年7月,阿美樂用於具有EGFR外顯子19缺失或外顯子21(L858R)置換突變陽性的NSCLC成人患者腫瘤切除術後的輔助治療上市許可申請(NDA)獲中國國家藥品監督管理局(NMPA)受理。2024年8月,阿美樂用於含鉑根治性放化療後未出現疾病進展的不可切除的局部晚期EGFR外顯子19缺失或外顯子21(L858R)置換突變的NSCLC患者治療NDA獲NMPA受理。
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