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 Real-world Study of Durvalumab for Lung Cancer in China

First Posted Date
2020-12-17
Last Posted Date
2020-12-17
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
100
Registration Number
NCT04672759
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, China

Observational Study of Durvalumab in Patients With Non-small-cell Lung Cancer in the United Kingdom

First Posted Date
2020-12-14
Last Posted Date
2023-10-02
Lead Sponsor
AstraZeneca
Target Recruit Count
115
Registration Number
NCT04667312
Locations
🇬🇧

East Kent Hospital, Canterbury, United Kingdom

🇬🇧

Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom

🇬🇧

Velindre Hospital, Cardiff, United Kingdom

and more 7 locations

Mechanism of Response to IMFINZI Neoadjuvant Therapy in Non-small Cell Lung Cancer Patients Based on Multiple-omics Models

First Posted Date
2020-11-30
Last Posted Date
2023-03-29
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
20
Registration Number
NCT04646837
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2020-11-25
Last Posted Date
2024-08-09
Lead Sponsor
AGO Research GmbH
Target Recruit Count
60
Registration Number
NCT04644289
Locations
🇩🇪

Universitätsklinikum Mannheim GmbH, Frauenklinik, Mannheim, Baden-Württemberg, Germany

🇩🇪

Mammazentrum HH am Krankenhaus Jerusalem, Gynäkologisches Operationszentrum Hamburg, Hamburg, Germany

🇩🇪

Charité Berlin, Klinik für Gynäkologie mit Zentrum für onkologische Chirurgie, Berlin, Germany

and more 3 locations

Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

First Posted Date
2020-11-24
Last Posted Date
2024-06-25
Lead Sponsor
AstraZeneca
Target Recruit Count
30
Registration Number
NCT04642469
Locations
🇻🇳

Research Site, Hochiminh, Vietnam

Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

First Posted Date
2020-11-16
Last Posted Date
2024-12-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
249
Registration Number
NCT04628767
Locations
🇺🇸

Kingman Regional Medical Center, Kingman, Arizona, United States

🇺🇸

Cancer Hematology Centers - Flint, Flint, Michigan, United States

🇺🇸

Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States

and more 244 locations

Study of Durvalumab + Tremelimumab in NSCLC Patients After Adjuvant Treatment

First Posted Date
2020-11-12
Last Posted Date
2023-06-06
Lead Sponsor
Catherine Shu
Registration Number
NCT04625699
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