Durvalumab

Generic Name
Durvalumab
Brand Names
Imfinzi
Drug Type
Biotech
Chemical Formula
-
CAS Number
1428935-60-7
Unique Ingredient Identifier
28X28X9OKV
Background

Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells.

Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma. In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ≥ 1% of tumour cells and there was no observable disease progression following platinum-based chemoradiation therapy. On March 27, 2020, durvalumab was approved by the FDA for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Indication

Durvalumab is indicated for the treatment of adults with the following conditions:

Associated Conditions
Extensive-stage Small Cell Lung Cancer (SCLC), Locally Advanced Biliary Tract Cancer, Metastatic Biliary Tract Cancer, Metastatic Non-Small Cell Lung Cancer, Unresectable Hepatocellular Carcinoma (HCC), Unresectable Stage III Non-small Cell Lung Cancer, Unresectable, locally advanced PD-L1 positive Lung Cancer Non-Small Cell Cancer (NSCLC)
Associated Therapies
First Line Chemotherapy

AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer

First Posted Date
2018-02-05
Last Posted Date
2024-08-21
Lead Sponsor
AstraZeneca
Target Recruit Count
76
Registration Number
NCT03421353
Locations
🇺🇸

Research Site, Fairfax, Virginia, United States

Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC

First Posted Date
2018-01-25
Last Posted Date
2024-01-03
Lead Sponsor
Canadian Cancer Trials Group
Target Recruit Count
129
Registration Number
NCT03410615
Locations
🇧🇪

University Hospital of Gent, Gent, Belgium

🇧🇪

AZ Sint Augustinus, Wilrijk, Belgium

🇨🇦

Cross Cancer Institute, Edmonton, Alberta, Canada

and more 23 locations

A Multicentre Phase II Trial of Durvalumab Versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinomas

First Posted Date
2018-01-23
Last Posted Date
2018-05-18
Lead Sponsor
National University Hospital, Singapore
Target Recruit Count
46
Registration Number
NCT03405454
Locations
🇸🇬

National University Hospital, Singapore, Singapore

🇸🇬

National Cancer Centre, Singapore, Singapore

IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma

First Posted Date
2017-12-21
Last Posted Date
2024-11-27
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
19
Registration Number
NCT03381183
Locations
🇺🇸

University of Michigan Health System, Ann Arbor, Michigan, United States

🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

First Posted Date
2017-12-19
Last Posted Date
2020-12-17
Lead Sponsor
Samsung Medical Center
Target Recruit Count
40
Registration Number
NCT03377400
Locations
🇰🇷

Samsung Medical Center, Seoul, MA, Korea, Republic of

Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma

First Posted Date
2017-12-18
Last Posted Date
2024-02-05
Lead Sponsor
Georgetown University
Target Recruit Count
8
Registration Number
NCT03376659
Locations
🇺🇸

Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States

Safety and Efficacy of Durvalumab Combined to Neoadjuvant Chemotherapy in Localized Luminal B HER2(-) and Triple Negative Breast Cancer.

First Posted Date
2017-11-29
Last Posted Date
2024-11-20
Lead Sponsor
Grand Hôpital de Charleroi
Target Recruit Count
57
Registration Number
NCT03356860
Locations
🇧🇪

Grand Hôpital de Charleroi, Charleroi, Hainaut, Belgium

🇧🇪

CHU UCL Namur - Sainte-Elisabeth, Namur, Région Wallonne, Belgium

🇧🇪

CHU UCL Namur - Site Godinne, Yvoir, Région Wallonne, Belgium

and more 1 locations

Durvalumab (MEDI4736) in Frail and Elder Patients With Metastatic NSCLC (DURATION)

First Posted Date
2017-11-17
Last Posted Date
2023-06-15
Lead Sponsor
AIO-Studien-gGmbH
Target Recruit Count
200
Registration Number
NCT03345810
Locations
🇩🇪

Klinikum Darmstadt, Darmstadt, Germany

🇩🇪

DRK-Kliniken Berlin Mitte, Berlin-Mitte, Germany

🇩🇪

Gesundheitszentrum St. Marien GmbH, Amberg, Germany

and more 27 locations
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