百濟神州(06160.HK)在AACR 2021年會公佈百澤安®治療二線或三線非小細胞肺癌RATIONALE 303臨試中期分析結果
格隆匯 4 月 13日丨百濟神州(06160.HK)於2021年4月12日(美國東部時間)在美國癌症研究協會(AACR)2021年年會上的一項口頭報吿中公佈了其抗PD-1抗體百澤安® (替雷利珠單抗)對比多西他賽針對二線或三線局部晚期或轉移性非小細胞肺癌(NSCLC)患者的全球3期臨牀試驗的中期分析結果。基於此項試驗結果的新適應症上市申請(sBLA)已於2021年3月在中國獲受理,目前正在接受審評。
百濟神州腫瘤免疫學首席醫學官賁勇醫學博士表示:“今天公佈的結果證明,百澤安®有望為二線或三線局部晚期或轉移性NSCLC患者帶來生存益處,這與我們在去年的ASCO以及ESMO年會上公佈針對初治患者的兩項試驗結果相一致。此外,百澤安®總體耐受,與先前在其他多項腫瘤中公佈的結果和已知風險相符。 RATIONALE 303的試驗結果鼓舞人心,不僅支持了百澤安®在中國已獲受理針對二或三線NSCLC的新適應症上市申請,也進一步表明百澤安®是一款潛在差異化檢查點抑制劑。”
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