長江生命科技(00775.HK):Polynoma將在ASCO20虛擬科學年會上展示黑色素瘤抗原疫苗免疫療法研究
格隆匯5月14日丨長江生命科技(00775.HK)發佈公告,公司的美國全資附屬公司Polynoma LLC (一間專注於腫瘤免疫學的生物製藥公司)進行研究的黑色素瘤候選疫苗seviprotimut-L第三階段臨牀研究的進展。Polynoma將在美國臨牀腫瘤學會(ASCO)於2020年5月29日至31日在網上舉行的ASCO20虛擬科學年會(ASCO20 Virtual Scientific Program)上,展示其基於黑色素瘤抗原疫苗免疫療法研究(Melanoma Antigen Vaccine Immunotherapy Study,為seviprotimut-L第三階段臨牀研究)B1部分所得臨牀數據而作出的最終分析。研究摘要經選定為黑色素瘤/皮膚癌壁報討論環節中進行討論的12項摘要之一。
根據披露,黑色素瘤抗原疫苗免疫療法研究是一項多中心、雙盲及安慰劑對照的第三階段適應性試驗,旨在評估seviprotimut-L的安全性和有效性,其主要終點為美國癌症聯合委員會(AJCC)第二B/C、第三A和第三B/C期於進行根除性手術切除後具高復發風險的黑色素瘤患者的無復發存活期(RFS)及整體存活率(OS),並按照與美國食品及藥物管理局達成的特殊評估協議進行。
將予展示的數據重點包括(a)第二B/二C期患者的效果改善,以及確認中期分析所得結果的次羣組最終分析,從而顯示使用seviprotimut-L後美國癌症聯合委員會第二B/二C期黑色素瘤患者,尤其是六十歲以下患者以及潰瘍病患者(其潰瘍情況因存在較高的轉移風險而被視為發生較嚴重病變)的無復發存活期較長,(b)至於六十歲以下的第二B/二C期黑色素瘤患者,以seviprotimut-L 治療的患者其整體存活率呈改善趨勢及(c)seviprotimut-L具備良好耐受性,治療期間出現的不良反應事件與服用安慰劑的患者類近,並無發生任何治療相關的不良反應事件。
Polynoma認為黑色素瘤抗原疫苗免疫療法研究B1部分的最終分析,進一步確定去年中期分析的所得結果,顯示使用seviprotimut-L後第二B/二C期黑色素瘤患者(尤其是六十歲以下患者及潰瘍病患者)的無復發存活期較長。 Polynoma相信,seviprotimut-L將會是作為侷限性黑色素瘤患者輔助性療法的重要新選項,而且此等數據對於seviprotimut-L作為以疫苗為基礎的治療方案,亦帶來曙光。Polynoma會進而將seviprotimut-L納入黑色素瘤抗原疫苗免疫療法研究的最終部分。
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