德琪醫藥-B(06996.HK)：塞利尼索(ATG-010)新適應症I/II期臨牀研究在中國獲得IND批准，用於治療非霍奇金淋巴瘤
格隆匯11月19日丨德琪醫藥-B(06996.HK)發佈公吿，國家藥監局已批准塞利尼索(ATG-010)聯合來那度胺和利妥昔單抗(R2方案)治療復發╱難治性瀰漫性大B細胞淋巴瘤(rrDLBCL)和復發╱難治性惰性非霍奇金淋巴瘤(rriNHL)的劑量探索和安全性的單臂I/II期研究。
根據披露，非霍奇金淋巴瘤(NHL)是世界上，也是中國最常見的血液腫瘤之一。2016年，中國NHL新增病例6.85萬例，死亡3.76萬例，分別佔全球NHL病例數和死亡例數的14.9%和15.7%。中國NHL年齡標準化發病率為4.29/10萬，死亡率為2.45/10萬，患病率為14.9/10萬，發病率和死亡率隨年齡呈上升趨勢。儘管利妥昔單抗聯合各種化療方案的一線治療能顯著改善NHL患者的總生存期(OS)，但rriNHL的治療仍存在着亟待滿足的臨牀需求。此外，雖然rrDLBCL的治療已經取得了良好進展，但有效的治療方式始終是一個挑戰。
主要研究者上海交通大學醫學院附屬瑞金醫院血液科主任醫師，中華醫學會血液分會副主任委員，中國臨牀腫瘤協會抗淋巴瘤聯盟副主席趙維蒞教授表示：“在現有的治療框架下，仍有部分DLBCL和iNHL患者不可避免地出現復發或難治的情況，且預後較差。因此，亟需全新機制的藥物和藥物組合，以滿足這一部分患者長期生存的需求，這也是臨牀醫生一直努力的方向。塞利尼索已獲美國FDA批准單藥治療rrDLBCL，本次開展的I/II期臨牀研究將探索塞利尼索聯合R2方案在不適合接受HDC/ASCT治療的rrDLBCL或rriNHL患者中的安全性和耐受性。我們希望SR2方案將為rriNHL患者帶來更有效的治療選擇。”
德琪醫藥創始人、董事長兼首席執行官梅建明博士表示：“很高興NMPA批准塞利尼索聯合R2方案治療rrDLBCL和rriNHL的劑量探索和安全性及有效性的單臂I/II期臨牀研究。塞利尼索(ATG-010)是德琪醫藥的首個商業化階段產品。這項針對塞利尼索的研究凸顯了德琪醫藥管線開發策略對於聯合療法的側重以及對於一些適應症的重點關注，其中包括rriNHL，塞利尼索尚未就該適應症獲美國FDA上市許可但在亞太區同樣存在亟待滿足的臨牀需求。我們期待在NMPA的監管下積極推進這項研究，為rrDLBCL和rriNHL患者帶來安全有效的新治療選擇。”
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