度伐利尤单抗

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
目標	CD274
臨床資料
商品名（英语：Drug nomenclature）	Imfinzi（英飞凡）
其他名稱	MEDI4736, MEDI-4736
AHFS/Drugs.com	Monograph
MedlinePlus	a617030
核准狀況	美 DailyMed: Durvalumab;
懷孕分級	澳: D ; ;
给药途径	静脉给药
ATC碼	L01XC28 (WHO) ;
法律規範狀態
法律規範	澳：限医生处方（S4）; 中：处方药 ; 歐：Rx-only; 英：处方药（℞-only） (POM); 美：处方药（℞-only）;
识别信息
CAS号	1428935-60-7
PubChem CID	249565666;
IUPHAR/BPS	7985;
DrugBank	DB11714;
ChemSpider	none;
UNII	28X28X9OKV;
KEGG	D10808 ;
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-L1与PD-1（CD279）。^[6]

事实速览 单克隆抗体, 种类 ...

关闭

FDA已批准度伐利尤单抗用于某些类型的膀胱癌和肺癌：^[2]

用于铂类化疗失败后的晚期或转移性膀胱癌的治疗。
用于铂类化疗联合放疗失败的III期非小细胞肺癌的治疗。
与依托泊苷和卡铂或顺铂联合使用，用于晚期小细胞肺癌的一线治疗。

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]

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]

[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]
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]
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）.

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）.

[Drugs.com_pregnancy-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）.

[Imfinzi_FDA_label-2] [2]
Imfinzi- durvalumab injection, solution. DailyMed. 5 June 2020 [30 September 2020]. （原始内容存档于2021-08-28）.

[Imfinzi_EPAR-3] [3]
Imfinzi EPAR. European Medicines Agency (EMA). [30 September 2020]. （原始内容存档于2021-08-28）.

[4] [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] [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）.

[:0-6] [6]
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] [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.

[NSCLC2016-8] [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] [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] [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] [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] [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] [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] [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）.

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度伐利尤单抗

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临床应用

临床试验

参考文献

外部链接