亞獅康-KY 發言日期 108/01/15 發言時間 06:13:31 發言人 傅勇 發言人職稱 董事長暨執行長 發言人電話 0227583333 主旨 亞獅康將於美國臨床腫瘤學會胃腸道腫瘤研討會(ASCO GI) 發表VARLITINIB 合併化療於一線膽道癌之正面數據 符合條款 第53款 事實發生日 108/01/15 說明 1.事實發生日:108/01/15 2.公司名稱:亞獅康股份有限公司 3.與公司關係(請輸入本公司或子公司):本公司 4.相互持股比例:不適用 5.發生緣由: 本公司將於2019年1月18日在美國舊金山所舉行之美國臨床腫瘤學會胃腸道腫瘤研討會 (ASCO GI)以壁報形式發表varlitinib合併gemcitabine與cisplatin(gem/cis)之一線膽 道癌1b/2期多中心臨床試驗正面數據，在300mg之試驗組中，觀察到60%之客觀反應率以及100%之疾病控制率。膽道癌病患對於varlitinib與gem/cis併用的耐受性高，數據顯示varlitinib合併gem/cis作為晚期/轉移性膽道癌一線療法的效果優於單獨使用 gem/cis化學療法。 截至2018年11月26日，該項臨床試驗的1b期部分已招收21名先前未接受過全身性治療的 晚期或轉移性膽道癌病患。病患接受一天兩次varlitinib 200mg或是300mg，並於治療 週期的第一天與第八天合併使用gemcitabine(1000mg/m2)與cisplatin(25mg/m2)，每三週重覆一個治療週期。有16名病患完成第一個治療週期的化學治療，並接受至少一次的治療後腫瘤掃描，故可評估其治療效果。其中7名出現部分反應(PR)，8名達疾病穩定(SD)，持續時間超過12週。兩組試驗組之整體客觀反應率與疾病控制率分別為43.8%及93.8%。在200mg試驗組收 治的11名受試者當中，有4名出現部分反應，6名達疾病穩定，客觀反應率為36.4%，疾 病控制率為90.9%。在300mg試驗組收治的5名受試者當中，有3名出現部分反應，2名達疾病穩定，客觀反應率為60%，疾病控制率為100%。以上數據優於膽道癌現有一線標準療法所根據的ABC-02試驗結果(Valle et. al., NEJM 2010)，該試驗中接受gem/cis之受試者之客觀反應率為26.1%，疾病控制率為81.4%。截至目前為止，膽道癌病患對varlitinib的耐受度高。兩個劑量試驗組中不良反應的發生率和嚴重程度相當，最常見的不良反應為血小板數量和嗜中性白血球數量減少。亞獅康-KY將繼續招收300mg試驗組的受試者，以完成這項1b期試驗。本公司亦將美國臨床腫瘤學會胃腸道腫瘤研討會(ASCO GI)發表另一項壁報，內容為 varlitinib合併含鉑(cisplatin或oxaliplatin)雙化療(5-flourouracil或 capecitabine或gemcitabine) 於膽道癌三項一期臨床試驗(ASLAN001-002、ASLAN001-002SG和ASLAN001-007)之合併分析數據。受試對象為一線、二線、三線或接 受過三線以上治療的晚期膽道癌病患。 截至2018年11月26日，共有43名晚期或轉移性膽道癌病患參與這三項試驗。研究利用客觀反應率、疾病控制率及治療反應強度來評估安全性、耐受性及療效之合併數據。分析結果顯示varlitinib 合併含鉑雙化療對於晚期且具高度轉移性之膽道癌病患具良好的療效。經合併分析評估，三項試驗中可評估治療反應之受試者，其客觀反應率與疾病控 制率分別為33.3%與81.5%。此外，varlitinib合併含鉑雙化療在所有劑量均展現良好安 全性與耐受性。摘要全文請參考以下連結https://meetinglibrary.asco.org，壁報於1月18日可於 亞獅康-KY官網查看或下載。6.因應措施:無 7.其他應敘明事項:新藥開發時程長、投入經費高且未保證一定能成功，此等可能使投資 面臨風險，投資人應審慎判斷謹慎投資。
Efficacy and safety of varlitinib, a reversible pan-HER tyrosine kinase inhibitor, in combination with platinum-based regimens in biliary tract cancers: A pooled analysis from three phase I studies. Presented Friday, January 18, 2019
Background: Varlitinib is a nanomolar inhibitor of EGFR, HER2, and HER4 and has shown potent anti-tumor activity as monotherapy in preclinical BTC models. During Phase (Ph) 1 development, significant tumor shrinkage was observed in biliary tract cancer (BTC) patients (pts). Tissue microarray analysis has revealed that ~70% of BTC pts exhibit HER overexpression, suggesting varlitinib could be beneficial in BTC.
Methods: Data from BTC pts were pooled from 3 Ph1 trials of varlitinib (dosed 200-500 mg BID) in combination with cisplatin and 5-FU/capecitabine (cape) (Study 002); oxaliplatin and 5-FU/cape (Study 002SG); cisplatin and gemcitabine (Study 007). The depth of tumor response, disease control rate (DCR), and treatment-related adverse events (TRAEs) were analysed.
Results: As of 12 June 2018, 43 pts were recruited: 12 (27.9%); 10 (23.3%) and 21 (48.8%) from study 002; 002SG and 007 respectively. 002SG and 007 were still ongoing at data cut-off. 20 (46.5%) pts were male and the median age was 62 years (range 42-82). Most tumors were cholangiocarcinoma (74.4%), followed by gallbladder cancer (16.3%) and carcinoma of the Ampulla of Vater (9.3%). 14 (32.6%) pts had received ≥ 1 prior lines of treatment. Of the 37 pts evaluable for efficacy (those with measurable disease and received ≥ 1 dose of treatment), partial responses were observed in 10 (27.0%) pts and stable disease in 16 (43.2%) pts, with a DCR of 70.3%. The median depth of tumor response was -10.8% (range 49.5% to -87.1%). Of 43 pts, the most frequent (≥ 30%) TRAE (any grade) were fatigue (37%), decreased appetite (34%), and nausea (32%) and the most common Grade ≥ 3 TRAE were hyperbilirubinemia (12%), increased AST (9%), and neutropenia (9%). The median PFS data is not matured and will be provided if evaluable at the time of presentation.
Conclusions: Varlitinib with platinum-based chemotherapy has a promising efficacy and safety profile in BTC. A Ph2/3 randomised study of varlitinib and cape in 2nd line BTC and a Ph1b/2 study of varlitinib with platinum-based chemotherapy in 1st line BTC are ongoing. Clinical trial information: NCT02648425, NCT02435927, and NCT02992340
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