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

Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer

First Posted Date
2021-03-01
Last Posted Date
2024-10-18
Lead Sponsor
AstraZeneca
Target Recruit Count
152
Registration Number
NCT04774380
Locations
🇹🇷

Research Site, Pamukkale, Turkey

Study of AZD2811 + Durvalumab in ES-SCLC

First Posted Date
2021-02-09
Last Posted Date
2022-12-15
Lead Sponsor
AstraZeneca
Target Recruit Count
31
Registration Number
NCT04745689
Locations
🇪🇸

Research Site, Valencia, Spain

Treating Early-stage Non-Small Cell Lung Cancer With Durvalumab and Radiation Therapy

First Posted Date
2021-01-20
Last Posted Date
2024-11-18
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
40
Registration Number
NCT04716946
Locations
🇺🇸

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

🇺🇸

Baptist Alliance - McI, Miami, Florida, United States

🇺🇸

Hartford Healthcare (Data Collection), Hartford, Connecticut, United States

and more 6 locations

Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

First Posted Date
2021-01-15
Last Posted Date
2024-11-22
Lead Sponsor
Colette Shen
Target Recruit Count
41
Registration Number
NCT04711824
Locations
🇺🇸

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

Memorial Healthcare System, Hollywood, Florida, United States

and more 4 locations

Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer

First Posted Date
2021-01-15
Last Posted Date
2023-07-20
Lead Sponsor
AstraZeneca
Target Recruit Count
101
Registration Number
NCT04712903
Locations
🇪🇸

Research Site, Zaragoza, Spain

Combining Epigenetic And Immune Therapy to Beat Cancer.

First Posted Date
2021-01-12
Last Posted Date
2023-03-01
Lead Sponsor
Institut Bergonié
Target Recruit Count
173
Registration Number
NCT04705818
Locations
🇫🇷

CHU Poitiers, Poitiers, France

🇫🇷

Institut Bergonie, Bordeaux, France

🇫🇷

CHRU Brest, Brest, France

Chemo-Immunotherapy Followed by Durvalumab and Ceralasertib in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer

First Posted Date
2021-01-07
Last Posted Date
2024-10-26
Lead Sponsor
Muhammad Furqan
Target Recruit Count
30
Registration Number
NCT04699838
Locations
🇺🇸

University of Illinois Medical Center, Chicago, Illinois, United States

🇺🇸

University of Maryland, Baltimore, Maryland, United States

🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

and more 2 locations
© Copyright 2024. All Rights Reserved by MedPath