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
Clinical Trials
Related News

Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC

First Posted Date
2020-09-16
Last Posted Date
2024-11-07
Lead Sponsor
AstraZeneca
Target Recruit Count
640
Registration Number
NCT04550260
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC

First Posted Date
2020-09-09
Last Posted Date
2023-03-23
Lead Sponsor
Ottawa Hospital Research Institute
Target Recruit Count
16
Registration Number
NCT04543110
Locations
🇨🇦

Cross Cancer Institute, Edmonton, Alberta, Canada

🇨🇦

Juravinski Cancer Centre, Hamilton, Ontario, Canada

🇨🇦

London Health Sciences Centre, London, Ontario, Canada

and more 1 locations

Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors

First Posted Date
2020-09-04
Last Posted Date
2024-12-06
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
4
Registration Number
NCT04538378
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

First Posted Date
2020-09-04
Last Posted Date
2024-12-13
Lead Sponsor
AstraZeneca
Target Recruit Count
245
Registration Number
NCT04538742
Locations
🇬🇧

Research Site, Buckhurst Hill, United Kingdom

Durvalumab and Tremelimumab in Combination With Either Y-90 SIRT or DEB-TACE for Intermediate Stage HCC

First Posted Date
2020-08-21
Last Posted Date
2023-09-01
Lead Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Target Recruit Count
55
Registration Number
NCT04522544
Locations
🇩🇪

Universitätsklinikum Essen, Essen, Germany

🇩🇪

Universitätsklinikum Bonn, Bonn, Germany

🇩🇪

Universitätsklinikum Freiburg, Freiburg, Germany

and more 6 locations

Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

First Posted Date
2020-08-20
Last Posted Date
2024-10-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
200
Registration Number
NCT04521686
Locations
🇺🇸

USC Norris Cancer Hospital, Los Angeles, California, United States

🇺🇸

University of Chicago Pritzker School of Medicine, Chicago, Illinois, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 27 locations

The Combination Therapy of TACE and Ablation With Durvalumab in Hepatocellular Carcinoma at Intermediate Stage (TAD)

First Posted Date
2020-08-18
Last Posted Date
2021-05-03
Lead Sponsor
Fudan University
Target Recruit Count
30
Registration Number
NCT04517227

A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

First Posted Date
2020-08-14
Last Posted Date
2024-12-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
829
Registration Number
NCT04513925
Locations
🇺🇸

Northwest Georgia Oncology Centers PC - Marietta, Marietta, Georgia, United States

🇺🇸

Illinois Cancer Care, Peoria, Illinois, United States

🇺🇸

New England Cancer Specialists, Brunswick, Maine, United States

and more 196 locations

First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

First Posted Date
2020-08-07
Last Posted Date
2024-11-05
Lead Sponsor
AstraZeneca
Target Recruit Count
60
Registration Number
NCT04504669
Locations
🇪🇸

Research Site, Madrid, Spain

Durvalumab and Tremelimumab in Combination With Chemotherapy in Virus-infected Patients With Non-small Cell Lung Cancer

First Posted Date
2020-08-05
Last Posted Date
2024-04-03
Lead Sponsor
Georgetown University
Target Recruit Count
18
Registration Number
NCT04499053
Locations
🇺🇸

Medstar Washington Hospital Center, Washington, District of Columbia, United States

🇺🇸

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

🇺🇸

Harry and Jeannette Weinberg Cancer Institute at Franklin Square, Baltimore, Maryland, United States

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