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

A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.

First Posted Date
2020-07-31
Last Posted Date
2023-08-09
Lead Sponsor
AstraZeneca
Target Recruit Count
30
Registration Number
NCT04495179
Locations
🇪🇸

Research Site, Madrid, Spain

Thoracic Radiotherapy Plus Maintenance Durvalumab After First Line Carboplatin and Etoposide Plus Durvalumab in Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC).

First Posted Date
2020-07-16
Last Posted Date
2023-09-13
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
46
Registration Number
NCT04472949
Locations
🇨🇭

Spital Männedorf, Männedorf, Switzerland

🇨🇭

Regionalspital Thun, Thun, Switzerland

🇨🇭

IOSI Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland

and more 11 locations

Study of Durvalumab or Durvalumab Plus Chemotherapy in Kras Mutation Positive and PD-L1 High (≥ 50%) NSCLC Patients

First Posted Date
2020-07-14
Last Posted Date
2022-03-03
Lead Sponsor
Shirish M Gadgeel
Registration Number
NCT04470674
Locations
🇺🇸

Henry Ford Health System, Detroit, Michigan, United States

Acalabrutinib and Durvalumab in Primary and Secondary Central Nervous System Lymphoma

First Posted Date
2020-07-08
Last Posted Date
2024-12-06
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
21
Registration Number
NCT04462328
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

The Ohio State University Hospital, Columbus, Ohio, United States

Concurrent Chemoradiation and Durvalumab for Locoregionally Advanced Nasopharyngeal Carcinoma

First Posted Date
2020-06-25
Last Posted Date
2020-06-25
Lead Sponsor
The University of Hong Kong
Target Recruit Count
118
Registration Number
NCT04447612
Locations
🇭🇰

Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, Hong Kong

Durvalumab and Lenvatinib in Participants With Advanced and Recurrent Endometrial Carcinoma

First Posted Date
2020-06-23
Last Posted Date
2020-06-23
Lead Sponsor
Shanghai First Maternity and Infant Hospital
Target Recruit Count
20
Registration Number
NCT04444193

Chemoradiation Followed by Durvalumab in Poor Risk And/or Elderly Patients with Stage III NSCLC

Phase 2
Suspended
Conditions
Interventions
First Posted Date
2020-06-22
Last Posted Date
2024-10-14
Lead Sponsor
Rush University Medical Center
Target Recruit Count
30
Registration Number
NCT04441138
Locations
🇺🇸

Rush University Cancer Center, Chicago, Illinois, United States

Study to Access Safety of Durvalumab in Indian Adult Patients With Locally Advanced NSCLC

First Posted Date
2020-06-04
Last Posted Date
2024-11-08
Lead Sponsor
AstraZeneca
Target Recruit Count
100
Registration Number
NCT04416633
Locations
🇮🇳

Research Site, New Delhi, India

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