迪哲醫藥(688192.SH):舒沃替尼關鍵劑量300mg組的最佳腫瘤緩解率(ORR)達52.4%
格隆匯8月4日丨迪哲醫藥(688192.SH)公佈,公司在2022年世界肺癌大會(WCLC)報吿舒沃替尼(DZD9008,sunvozertinib)最新臨牀研究數據。截至2022年4月30日,在既往接受過含鉑化療、攜帶EGFR20號外顯子插入突變的非小細胞肺癌患者中,舒沃替尼關鍵劑量300mg組的最佳腫瘤緩解率(ORR)達52.4%,其中在基線有腦轉移的患者中ORR為44%。
肺癌是全球第二大惡性腫瘤,非小細胞肺癌約佔85%,最常見的突變是EGFR突變。EGFR20號外顯子插入(Exon20ins)突變佔EGFR突變的4%–12%,由於其獨特的蛋白結構,臨牀標準療法僅有化療,有效率不到20%,生存獲益短,存在較大的未滿足的臨牀需求。
舒沃替尼是公司自主研發的特異性表皮生長因子受體酪氨酸激酶抑制劑(EGFR-TKI),對包括Exon20ins突變在內的多種EGFR突變和HER220號外顯子插入突變都有較強活性,並保持對野生型EGFR高選擇性。舒沃替尼的首選適應症為EGFR20號外顯子插入突變非小細胞肺癌,正在中國、美國、歐洲、韓國、澳大利亞等國家和地區開展關鍵性註冊臨牀試驗,主要研究終點是經獨立影像評審委員會評估的ORR。
舒沃替尼能夠高效抑制EGFR Exon20ins各突變亞型;安全性良好,絕大多數治療期間患者出現的不良事件(AE)為CTCAE1級或2級,可通過安全性管理進行恢復。舒沃替尼的最新臨牀研究結果除了此次在2022WCLC做大會報吿外,還將於9月24日在北美洲肺癌大會(2022NACLC)做大會口頭報吿。
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