來凱醫藥(2105.HK)在2024 ESMO大會上公佈LAE002 (afuresertib) 治療HR+/HER2- 乳腺癌Ib期臨牀優異數據
- 58.1%的受試者伴有PIK3CA/AKT1/PTEN通路改變，64.5%受試者既往接受過CDK4/6抑制劑治療
- 確認的ORR為33.3%，臨牀獲益率66.7%，PFS為7.3個月
- 已報道的CAPItello-291 III 期研究的中國橋接研究，在PIK3CA/AKT1/PTEN通路改變人羣中，capivasertib/氟維司羣聯合治療組PFS數據為5.7個月，氟維司羣單藥治療的PFS數據1.9個月
- 徐兵河院士牽頭，III期臨牀試驗AFFIRM-205進展順利、比原計劃提前
2024年9月19日——在剛剛舉行的2024年歐洲腫瘤內科學會(ESMO)大會上，來凱醫藥(2105.HK)公佈了其創新產品LAE002（afuresertib，一種口服AKT抑制劑）聯合氟維司羣（下簡稱“聯合療法”），用於標準治療失敗的局部晚期或轉移性HR+/HER2-乳腺癌患者Ib期研究的最終數據。在18位PIK3CA/AKT1/PTEN變異的乳腺癌患者中，中位無進展生存期(PFS)為7.3個月。
該Ib期臨牀試驗是一項單臂、開放標籤研究，旨在評估“聯合療法”對HR+/HER2-乳腺癌患者的療效和安全性，這些患者曾接受1-2線內分泌治療（聯合或不聯合CDK4/6抑制劑（≤1線）和/或≤1線化療）後出現進展。
截至2024年8月27日，該Ib研究共入組31名受試者，含28位中國和3位美國受試者，受試者的中位年齡為54歲。其中71.0%的受試者接受過1線治療，29.0%的受試者接受過二線治療。18位患者伴有PIK3CA/AKT1/PTEN改變，佔受試者的58.1%；入組患者中64.5%既往接受過CDK4/6抑制劑治療，中位隨訪時間為17.3個月。在中美31位全受試者人羣、以及伴有PIK3CA/AKT1/PTEN改變的亞組人羣中，該療法都顯示出顯著的抗癌療效和良好的耐受安全性。
在18名PIK3CA/AKT1/PTEN變異患者中：
- 確認的客觀緩解率（ORR)為33.3%
- 臨牀獲益率為66.7%
- 中位無進展生存期(PFS)為7.3個月
-已報道CAPItello-291 III期研究的中國橋接研究，在PIK3CA/AKT1/PTEN基因改變人羣中，capivasertib/氟維司羣聯合治療的PFS數據5.7個月，氟維司羣單藥治療的PFS數據1.9個月[ ESMOAsia2023capivasertib+fulvestrantforpatientswitharomataseinhibitor-resistantHR-positive/HER2-negativeadvancedbreastcancer:Phase3CAPItello-291trialChinesecohort]
來凱醫藥已於2024年5月在中國啟動了後續III期關鍵臨牀試驗AFFIRM-205，由中國醫學科學院腫瘤醫院徐兵河院士牽頭，用於治療PIK3CA/AKT1/PTEN改變的HR+/HER2-乳腺癌患者。目前項目進展順利，比計劃的時間表提前。
“此次ESMO大會上公佈的聯合療法Ib期數據，特別是對伴有PIK3CA/AKT1/PTEN改變受試者顯示出積極的療效和安全性，公司對AFFIRM-205取得積極成果和遞交藥品上市申請充滿信心。”來凱醫藥董事會主席兼首席執行官呂向陽博士表示，“目前III期臨牀正在全國各中心全速、高效推進，我們對此深感振奮，並將竭盡全力、儘快惠及患者。”
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.
