奧賽康(002755.SZ)：子公司新藥ASK120067片在2022 ASCO年會展示臨牀數據
格隆匯6月7日丨奧賽康(002755.SZ)公佈，公司的全資子公司江蘇奧賽康藥業有限公司(簡稱“奧賽康藥業”)於2022年6月6日上午在美國臨牀腫瘤學會(ASCO)年會上以壁報的形式展示了ASK120067片IIb期臨牀研究結果。
摘要編號：9106
標題：ASK120067(limertinib)片在既往EGFR-TKI治療後進展的T790M+局部晚期或轉移性非小細胞肺癌(NSCLC)患者中療效、安全性的多中心、單臂IIb期臨牀研究
內容概要：本研究為多中心、開放、單臂IIb期臨牀研究，探索了ASK120067片治療既往EGFR-TKI治療後進展的EGFR T790M+局部晚期或轉移性NSCLC的療效與安全性。本研究共納入了來自62家中心的301例患者。其中，61.1%和33.2%的患者分別為EGFR 19del突變和EGFR L858R突變，32.9%的患者為無症狀、穩定的腦轉移(CNS)患者。截至2021年9月9日，76例患者(25.2%)仍在接受ASK120067片治療，中位隨訪時間為10.4個月。
有效性方面，研究結果顯示ASK120067片治療既往EGFR-TKI治療後進展的T790M+局部晚期或轉移性NSCLC患者，經獨立評審委員會(IRC)評估的客觀緩解率(ORR)為68.8%，疾病控制率(DCR)為92.4%，緩解持續時間(DoR)為11.1個月，無進展生存期(PFS)為11.0個月。CNS患者顱內ORR為56.1%，CNS患者PFS為10.6個月，提示ASK120067片對CNS患者具有較好的療效。總生存期(OS)數據尚未成熟。
安全性方面，ASK120067片用於既往EGFR-TKI治療後進展的T790M+的局部晚期或轉移性NSCLC患者安全耐受性良好，絕大部分患者會發生不良反應，但多為1級或2級。最常見的3級及以上不良反應為腹瀉、低鉀血癥、貧血和皮疹，以上不良反應經降低治療劑量、暫停給藥或給予支持治療後等可恢復或緩解。
綜上所述，ASK120067片用於治療既往EGFR-TKI治療後進展的T790M+局部晚期或轉移性NSCLC患者具有較好的療效和安全性，可為第一代或第二代EGFR-TKI耐藥後產生T790M突變的NSCLC患者提供新的有效的治療選擇。
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