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貝達藥業(300558.SZ):埃克替尼INCREASE研究成果在國際著名腫瘤學期刊《臨牀腫瘤研究》發表
格隆匯 02-16 17:46

格隆匯2月16日丨貝達藥業(300558.SZ)公佈, 2 1 4 由北京首都醫科大學附屬北京胸科醫院張樹才教授團隊完成 的埃克替尼加量用於治療 EGFR 21 外顯子 L858R 突變( 21 - L858R ) 晚期非小 細胞肺癌( NSCLC )的II期臨牀研究(“ INCREASE 研究”)成果在國 著名 腫瘤學期刊《臨牀腫瘤研究》( Clinical Cancer Reearch )在線發表, 研究成果提示高劑量埃克替尼可以有效改善 NSCLC 患者 21 - L858R 突變的 mPFS ORR ,且具有可接受的耐受性, 可以 為一種新的治療選擇。

《臨牀腫瘤研究》是全球最有影響力的美國癌症研究協會( AACR )的官方期 刊。作為國際臨牀腫瘤權威期刊,主要發表新穎性強、基礎與臨牀結合的重要癌 症相關研究論文,在國際癌症研究領域具有重要的影響力。

肺癌分為非小細胞肺癌( NSCLC )和小細胞肺癌( SCLC ), NSCLC 約佔肺 癌的 85% ,而 EGFR 突變是 NSCLC 常見的基因突變類型。這其中, 19 外顯子缺 失( 19 - Del )和 21 - L858R 突變又是 EGFR 突變最常見的亞型,佔 EGFR 突變陽性 NSCLC 90% 。儘管它們都被認為是 EGFR - TKI 反應的預測因子,但與 19 - Del 突變腫瘤患者相比, 21 - L858R 突變腫瘤患者在 EGFR - TKI 治療時表現出的臨牀療 效略差。

INCREASE 研究主要目的是探討高劑量埃克替尼與常規劑量埃克替尼治療 21 - L858R 突變的 NSCLC 的安全性和有效性。自 2015 5 月至 2017 11 月,共 入組 253 名患者,主要研究終點是由獨立評審委員會( IRC )評估的中位無進展生 存期( mPFS )。研究結果顯示, 21 - L858R 突變高劑量患者組 mPFS 明顯長於常規 劑量患者組( 12.9 個月 v. 9.2 個月),客觀緩解率( ORR )也更高( 73% v. 48% ), 19 - Del 突變常規劑量患者組相近(分別為 12.9 個月 v. 12.5 個月; 73% v. 75% )。 皮疹、腹瀉和轉氨酶水平升高仍然是所有組中最常見的不良事件,其中大多數為 1/2 級且可控制。這提示,高劑量埃克替尼可以有效改善 NSCLC 患者 21 - L858R 變的 mPFS ORR ,且具有可接受的耐受性, 可以 成為一種新的治療選擇。

埃克替尼加量用於治療 EGFR 21 突變 的研究顯示埃克替尼可以使 21 突變患者 獲益,填補了 21 突變 既往 TKI 療效沒有 19 突變獲益的空白,再次證明 EGFR 個通道的證據更多是要由亞洲和中國專家來解讀,也可以看到以埃克替尼為代表 的中國創新藥與眾不同的特點,相信會給中國更多的 21 突變的肺癌患者帶來新的 選擇。

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