基石藥業-B(02616.HK)在2020年CSCO年會上公佈GIST精準靶向藥阿泊替尼在中國患者羣的橋接研究初步結果
格隆匯 9 月 24日丨基石藥業-B(02616.HK)發佈公告，基石藥業在2020年中國臨牀腫瘤協會(“CSCO”)學術年會上公佈了抗腫瘤藥物Avapritinib(“阿泊替尼”)在中國I/II期橋接不可切除或轉移性胃腸道間質瘤(“GIST”)研究用於治療患者取得的積極結果。阿泊替尼由基石藥業全球合作伙伴Blueprint Medicines Corporation(納斯達克股份代號：BPMC)開發。
北京大學腫瘤醫院副院長沈琳教授表示：“由於現有療法的獲益極為有限，PDGFRA D842V突變的GIST患者具有高度未滿足的治療需求。阿泊替尼在PDGFRAD842V突變的中國晚期GIST患者中表現出了非常好的抗腫瘤活性，且安全性和耐受性良好。作為臨牀醫生，我很高興的看到GIST的治療進入了精準靶向時代，同時期盼阿泊替尼能早日獲批，成為這部分GIST患者新的治療選擇。”
基石藥業首席醫學官楊建新博士表示：“我們很高興在2020年CSCO年會議上公佈GIST精準靶向藥物阿泊替尼在中國人羣中的I/II期初步橋接研究結果。研究顯示阿泊替尼在中國GIST患者中耐受性良好，並證明該藥對攜帶PDGFRA D842V突變的中國患者具有很強的抗腫瘤活性。基石藥業於2020年7月和4月分別向中國台灣食品藥物管理署(“TFDA”)和中國國家藥物監督管理局遞交了這款藥物的新藥上市申請(“NDA”)，並於2020年7月獲得中國藥監局的優先審評資格。我們期待阿泊替尼可以早日造福中國患者。”
根據披露，阿泊替尼是一種激酶抑制劑，美國食品藥品監督管理局(“FDA”)已批准其以商品名AYVAKITTM上市銷售，用於治療攜帶PDGFRA18號外顯子突變(包括PDGFRA D842V突變)的不可切除性或轉移性GIST成人患者。此前，FDA曾授予阿泊替尼突破性療法認定，用於治療攜帶PDGFRAD842V突變的不可切除性或轉移性GIST成人患者。
GIST是發生於胃腸道的肉瘤，肉瘤是發生在骨內或源自結締組織的腫瘤。胃腸間質瘤起源於胃腸道壁中的細胞，並且最常發生在胃或小腸中。大多數患者的確診年齡在50至80歲之間，通常在胃腸道出血、做手術或醫學影像檢查時發現，極少在腫瘤破裂或胃腸道發生梗阻後確診。
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