奧賽康(002755.SZ):利厄替尼片III期臨牀研究結果在《柳葉刀·呼吸病學》發佈
格隆匯6月23日丨奧賽康(002755.SZ)公佈,公司一類創新藥利厄替尼片(奧壹新®)近日在國際頂級醫學期刊《柳葉刀·呼吸病學》(IF:32.8)發佈該產品的III期臨牀研究結果。利厄替尼片是第三代表皮生長因子受體(EGFR)酪氨酸激酶抑制劑(TKI),用於具有EGFR突變的局部晚期或轉移性非小細胞肺癌(NSCLC)成人患者的一線、二線治療。
利厄替尼整體安全性良好,研究中未觀察到新的安全性信號。利厄替尼常見不良反應為腹瀉和皮疹,大多為1-2級。患者劑量中斷或調整比例較低,能夠持續接受治療,永久停藥發生率為2%,發生率是同類藥物相同臨牀研究中最低的。此外,與同類國產藥物相比,利厄替尼的肝毒性較低,ALT升高和AST升高的發生率分別為16%和18%。
奧壹新®(通用名:利厄替尼片)在EGFR敏感突變陽性晚期NSCLC一線治療的患者中展現出了顯著的療效和安全性,腦轉移療效突出。
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