翰森製藥(03692.HK)將在2021 ASCO年會發布阿美樂®一線治療EGFR突變NSCLC的III期研究結果
格隆匯5月20日丨翰森製藥(03692.HK)宣佈，由公司附屬公司江蘇豪森藥業集團有限公司開發的1.1類創新藥阿美樂®(甲磺酸阿美替尼片，HS-10296)一線治療具有表皮生長因子受體(“EGFR”)敏感突變陽性局部晚期或轉移性非小細胞肺癌(“NSCLC”)III期臨牀研究(“AENEAS研究”)達到主要研究終點。具體研究結果將於6月4日在2021年美國臨牀腫瘤學會(ASCO)年會上以壁報討論形式展示(壁報摘要編號9013)。
AENEAS研究顯示，與吉非替尼相比，使用阿美樂作為一線治療的患者，無進展生存期(“PFS”)顯著延長(中位PFS 19.3個月 vs 9.9個月，HR 0.46, p-value<0.0001)，持續緩解時間(“DoR”)也顯著延長(中位DoR 18.1個月 vs 8.3個月，HR 0.38, p-value <0.0001)，總生存期(“OS”)數據目前尚未成熟。
AENEAS研究數據顯示，儘管阿美樂組用藥時間顯著延長(中位用藥時間463天vs 254天)，其藥物相關的皮疹、腹瀉、AST/ALT升高及藥物相關的嚴重不良反應(SAEs)發生率更低(SAEs：阿美替尼4.2% vs 吉非替尼11.2%)。
AENEAS研究結論顯示，與吉非替尼相比，阿美樂用於一線治療EGFR突變陽性局晚期或轉移性NSCLC，可顯著延長患者PFS及DoR，並具有更好的安全性，有潛力成為該類患者新的治療選擇。公司已與EQRx, INC.合作，拓展阿美樂在大中華區以外市場。
公吿顯示，AENEAS研究是一項隨機雙盲對照的多中心三期臨牀研究，研究阿美樂對比吉非替尼作為一線針對EGFR突變陽性局部晚期或轉移性非小細胞肺癌患者的治療。
研究的主要終點是PFS，次要終點包括OS，客觀緩解率(ORR)和DoR以及安全性。總計429例受試者在53家中國中心被招募，並按照1:1比例隨機接受阿美樂(一日一次110mg)或者吉非替尼(一日一次，250mg)治療。
而阿美樂是一種新型的，不可逆的表皮生長因子受體酪氨酸激酶抑制劑(“EGFRTKI”)，具有良好的藥學特性可以選擇性的抑制EGFR敏感和耐受突變。阿美樂每日治療劑量為110毫克的片劑，已經被NMPA批准作為用於既往經EGFR TKI治療時或治療後出現疾病進展的，存在EGFR T790M突變陽性的局部晚期或轉移性NSCLC患者的藥品。
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