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度伐利尤单抗

维基百科,自由的百科全书
度伐利尤单抗(Durvalumab)
度伐利尤单抗(浅绿色)与PD-L1(粉色)的结合物。PDB 5X8M
单克隆抗体
种类完整抗体
目标CD274
临床资料
商品名英语Drug nomenclatureImfinzi(英飞凡)
其他名称MEDI4736, MEDI-4736
AHFS/Drugs.comMonograph
MedlinePlusa617030
核准状况
怀孕分级
给药途径静脉给药
ATC码
法律规范状态
法律规范
识别信息
CAS号1428935-60-7
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
  • none
UNII
KEGG
化学信息
化学式C6502H10018N1742O2024S42
摩尔质量146,322.36 g·mol−1

度伐利尤单抗Durvalumab [4],商品名Imfinzi,中文商品名英飞凡)是一种用于治疗癌症的完全人源化抗PD-L1单克隆抗体。该药由阿斯利康全资子公司MedImmune研发。 [5]它是一种人类免疫球蛋白G1κ(IgG1κ)单克隆抗体,可阻断PD-L1PD-1(CD279)。[6]

临床应用

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FDA已批准度伐利尤单抗用于某些类型的膀胱癌和肺癌:[2]

NMPA于2019年12月批准该药用于铂类化疗联合放疗失败的III期非小细胞肺癌的治疗。[7]

临床试验

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度伐利尤单抗的ⅠB期临床试验结果表明该药对非小细胞肺癌(NSCLC)具有抑制作用,[8]该药另一项关于晚期转移性膀胱癌适应症的Ⅰ期临床试验则被FDA纳入快速审批通道。[6][9]度伐利尤单抗联合吉非替尼治疗小细胞肺癌的Ⅰ期临床试验结果表明该联合用药方案具有很好的疗效。[10]目前,该药正在进行一项与TLR 7/8激动剂(MEDI 9197)联合治疗实体瘤的Ⅰ期临床试验[11]以及一项与HPV疫苗(MEDI 0457)联合治疗HPV相关的复发/转移性头颈癌的Ⅱ期临床试验。[12]

2017年7月,阿斯利康宣布,度伐利尤单抗用于非小细胞肺癌一线治疗的Ⅲ期临床试验未能达到预期终点。 [13]

2017年11月,Ⅲ期双盲临床试验表明了度伐利尤单抗对III期非小细胞肺癌具有一定疗效。[14]

参考文献

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  1. ^ 1.0 1.1 Durvalumab (Imfinzi) Use During Pregnancy. Drugs.com. 30 August 2019 [7 February 2020]. (原始内容存档于2021-08-29). 
  2. ^ 2.0 2.1 Imfinzi- durvalumab injection, solution. DailyMed. 5 June 2020 [30 September 2020]. (原始内容存档于2021-08-28). 
  3. ^ Imfinzi EPAR. European Medicines Agency (EMA). [30 September 2020]. (原始内容存档于2021-08-28). 
  4. ^ International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 112 (PDF). WHO Drug Information. 2014, 28 (4) [2020-12-15]. (原始内容存档 (PDF)于2021-08-28). 
  5. ^ Research, Center for Drug Evaluation and. Approved Drugs - Durvalumab (Imfinzi). www.fda.gov. [2017-05-06]. (原始内容存档于2017-05-08). 
  6. ^ 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. 
  7. ^ 阿斯利康PD-L1抑制剂度伐利尤单抗注射液在华获批. 阿斯利康中国. 2019-12-12. 
  8. ^ 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]. (原始内容存档于2016-02-15). 
  9. ^ AstraZeneca's (AZN) Durvalumab Granted FDA Breakthrough Therapy Designation页面存档备份,存于互联网档案馆). StreeInsider.com Corporate News, FDA, Management Comments. 17 February 2016.
  10. ^ Promising Drug for Lung Cancer and Mesothelioma Patients. 19 May 2016 [2020-12-15]. (原始内容存档于2021-08-28). 
  11. ^ 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
  12. ^ 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
  13. ^ AstraZeneca reports initial results from the ongoing MYSTIC trial in Stage IV lung cancer. www.astrazeneca.com. [2020-12-15]. (原始内容存档于2021-08-28). 
  14. ^ 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]. (原始内容存档于2021-08-28). 

外部链接

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  • Durvalumab. Drug Information Portal. U.S. National Library of Medicine. [2020-12-15]. (原始内容存档于2021-12-12). 
  • Durvalumab. NCI Drug Dictionary. National Cancer Institute. [2020-12-15]. (原始内容存档于2021-08-28). 
  • Durvalumab. National Cancer Institute. [2020-12-15]. (原始内容存档于2021-08-28).