度伐利尤單抗
單株抗體 | |
---|---|
種類 | 完整抗體 |
目標 | CD274 |
臨床資料 | |
商品名 | Imfinzi(英飛凡) |
其他名稱 | MEDI4736, MEDI-4736 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a617030 |
核准狀況 | |
懷孕分級 | |
給藥途徑 | 靜脈給藥 |
ATC碼 | |
法律規範狀態 | |
法律規範 |
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識別資訊 | |
CAS號 | 1428935-60-7 |
PubChem CID | |
IUPHAR/BPS | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
化學資訊 | |
化學式 | C6502H10018N1742O2024S42 |
摩爾質量 | 146,322.36 g·mol−1 |
度伐利尤單抗(Durvalumab [4],商品名Imfinzi,中文商品名英飛凡)是一種用於治療癌症的完全人源化抗PD-L1單株抗體。該藥由阿斯利康全資子公司MedImmune研發。 [5]它是一種人類免疫球蛋白G1κ(IgG1κ)單株抗體,可阻斷PD-L1與PD-1(CD279)。[6]
臨床應用
NMPA於2019年12月批准該藥用於鉑類化療聯合放療失敗的III期非小細胞肺癌的治療。[7]
臨床試驗
度伐利尤單抗的ⅠB期臨床試驗結果表明該藥對非小細胞肺癌(NSCLC)具有抑制作用,[8]該藥另一項關於晚期轉移性膀胱癌適應症的Ⅰ期臨床試驗則被FDA納入快速審批通道。[6][9]度伐利尤單抗聯合吉非替尼治療小細胞肺癌的Ⅰ期臨床試驗結果表明該聯合用藥方案具有很好的療效。[10]目前,該藥正在進行一項與TLR 7/8激動劑(MEDI 9197)聯合治療實體瘤的Ⅰ期臨床試驗[11]以及一項與HPV疫苗(MEDI 0457)聯合治療HPV相關的復發/轉移性頭頸癌的Ⅱ期臨床試驗。[12]
2017年7月,阿斯利康宣佈,度伐利尤單抗用於非小細胞肺癌一線治療的Ⅲ期臨床試驗未能達到預期終點。 [13]
2017年11月,Ⅲ期雙盲臨床試驗表明了度伐利尤單抗對III期非小細胞肺癌具有一定療效。[14]
參考文獻
- ^ 1.0 1.1 Durvalumab (Imfinzi) Use During Pregnancy. Drugs.com. 30 August 2019 [7 February 2020]. (原始內容存檔於2021-08-29).
- ^ 2.0 2.1 Imfinzi- durvalumab injection, solution. DailyMed. 5 June 2020 [30 September 2020]. (原始內容存檔於2021-08-28).
- ^ Imfinzi EPAR. European Medicines Agency (EMA). [30 September 2020]. (原始內容存檔於2021-08-28).
- ^ International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 112 (PDF). WHO Drug Information. 2014, 28 (4) [2020-12-15]. (原始內容存檔 (PDF)於2021-08-28).
- ^ Research, Center for Drug Evaluation and. Approved Drugs - Durvalumab (Imfinzi). www.fda.gov. [2017-05-06]. (原始內容存檔於2017-05-08).
- ^ 6.0 6.1 Syn, Nicholas L; Teng, Michele W L; Mok, Tony S K; Soo, Ross A. De-novo and acquired resistance to immune checkpoint targeting. The Lancet Oncology. 2017, 18 (12): e731–e741. PMID 29208439. doi:10.1016/s1470-2045(17)30607-1.
- ^ 阿斯利康PD-L1抑制剂度伐利尤单抗注射液在华获批. 阿斯利康中國. 2019-12-12.
- ^ Astrazeneca's combination of durvalumab with tremelimumab shows clinical activity in non-small cell lung cancer irrespective of PD-L1 status. Feb 2016. [2020-12-15]. (原始內容存檔於2016-02-15).
- ^ AstraZeneca's (AZN) Durvalumab Granted FDA Breakthrough Therapy Designation (頁面存檔備份,存於互聯網檔案館). StreeInsider.com Corporate News, FDA, Management Comments. 17 February 2016.
- ^ Promising Drug for Lung Cancer and Mesothelioma Patients. 19 May 2016 [2020-12-15]. (原始內容存檔於2021-08-28).
- ^ Clinical trial number NCT02556463 for "A Study of MEDI9197 in Subjects With Solid Tumors or CTCL and in Combination With Durvalumab and/or Palliative Radiation in Subjects With Solid Tumors" at ClinicalTrials.gov
- ^ Clinical trial number NCT03162224? for "Safety and Efficacy of MEDI0457 and Durvalumab in Patients With HPV Associated Recurrent/Metastatic Head and Neck Cancer" at ClinicalTrials.gov
- ^ AstraZeneca reports initial results from the ongoing MYSTIC trial in Stage IV lung cancer. www.astrazeneca.com. [2020-12-15]. (原始內容存檔於2021-08-28).
- ^ AstraZeneca presents superior progression-free survival for Imfinzi in the PACIFIC trial of patients with locally-advanced unresectable lung cancer at ESMO 2017 Congress. www.astrazeneca.com. Sep 2017 [2020-12-15]. (原始內容存檔於2021-08-28).
外部連結
- Durvalumab. Drug Information Portal. U.S. National Library of Medicine. [2020-12-15]. (原始內容存檔於2021-12-12).
- Durvalumab. NCI Drug Dictionary. National Cancer Institute. [2020-12-15]. (原始內容存檔於2021-08-28).
- Durvalumab. National Cancer Institute. [2020-12-15]. (原始內容存檔於2021-08-28).