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迪哲醫藥(688192.SH):舒沃替尼治療EGFR20號外顯子插入(Exon20ins)突變型晚期非小細胞肺癌的中國註冊臨牀研究達到主要終點
格隆匯 09-05 20:58

格隆匯9月5日丨迪哲醫藥(688192.SH)公佈,公司在2022年歐洲腫瘤內科學會(ESMO)大會公佈了舒沃替尼(DZD9008,sunvozertinib)治療EGFR20號外顯子插入(Exon20ins)突變型晚期非小細胞肺癌的中國註冊臨牀試驗研究結果,由盲態獨立中心評估委員會(BICR)評估確認的腫瘤緩解率(ORR)為59.8%,該註冊臨牀試驗達到主要終點。

舒沃替尼是一款口服、針對多種EGFR突變亞型的高選擇性酪氨酸激酶抑制劑,憑藉其出色的療效和安全性,成為迄今為止肺癌領域首個且唯一獲中美雙“突破性療法認定”的1類新藥。本屆ESMO年會公佈了舒沃替尼首個註冊臨牀研究WU-KONG6的初步分析結果。

截至2022年7月31日,接受舒沃替尼(300mg QD)治療的97例經化療失敗的、EGFR Exon20ins突變型晚期NSCLC患者納入療效分析集。初步分析結果顯示:

(1)經BICR判定臨牀研究達到預設主要終點,經確認的ORR為59.8%

(2)基線伴有腦轉移患者經確認的ORR為48.4%

(3)納入了30多種EGFR Exon20ins突變亞型,不論插入突變發生位置,均觀察到舒沃替尼抗腫瘤活性

安全性分析數據來自舒沃替尼國內外多中心臨牀研究的彙總分析。截至2022年7月31日,共納入277名接受至少1次舒沃替尼治療的晚期NSCLC患者。研究結果顯示:舒沃替尼整體安全性良好,常見不良反應類型與傳統EGFR-TKI類似,且絕大多數為1-2級不良反應,臨牀可管理及恢復。

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