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

Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours

First Posted Date
2021-08-11
Last Posted Date
2024-06-26
Lead Sponsor
AstraZeneca
Target Recruit Count
126
Registration Number
NCT04999969
Locations
🇪🇸

Research Site, Pamplona, Spain

TACE and SBRT Followed by Double Immunotherapy for Downstaging Hepatocellular Carcinoma

First Posted Date
2021-08-04
Last Posted Date
2023-09-06
Lead Sponsor
The University of Hong Kong
Target Recruit Count
33
Registration Number
NCT04988945
Locations
🇭🇰

Department of Surgery, The University of Hong Kong, Hong Kong, Hong Kong

🇭🇰

The University of Hong Kong, Hong Kong, Hong Kong

To Evaluate the Efficacy of Durvalumab + Anlotinib in Terms of OS and PFS.

Not Applicable
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-08-02
Last Posted Date
2023-12-01
Lead Sponsor
Shanghai Chest Hospital
Target Recruit Count
90
Registration Number
NCT04985851
Locations
🇨🇳

Shanghai Chest Hospital, Shanghai, Shanghai, China

A Study to Evaluate the Safety of Concurrent Durvalumab With CRT Followed by Durvalumab for Chinese Unresectable Stage III NSCLC

First Posted Date
2021-07-29
Last Posted Date
2021-08-06
Lead Sponsor
Shandong Cancer Hospital and Institute
Target Recruit Count
35
Registration Number
NCT04982549
Locations
🇨🇳

Shanghai Pulmonary Hospital, Shanghai, Shanghai, China

🇨🇳

Henan Cancer Hospital, Zhengzhou, Henan, China

A Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer

First Posted Date
2021-07-06
Last Posted Date
2024-11-26
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
6
Registration Number
NCT04951115
Locations
🇺🇸

New York-Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States

🇺🇸

Weill Cornell Medicine, New York, New York, United States

🇺🇸

New York-Presbyterian Queens, Flushing, New York, United States

Hepatic Artery Infusion Chemotherapy (HAIC) Plus Durvalumab for Advanced Hepatocellular Carcinoma

First Posted Date
2021-06-30
Last Posted Date
2023-03-22
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
30
Registration Number
NCT04945720
Locations
🇨🇳

Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer

First Posted Date
2021-06-08
Last Posted Date
2024-07-18
Lead Sponsor
Canadian Cancer Trials Group
Target Recruit Count
60
Registration Number
NCT04918186
Locations
🇨🇦

The Jewish General Hospital, Montreal, Quebec, Canada

🇨🇦

CHUM-Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada

🇨🇦

Odette Cancer Centre, Toronto, Ontario, Canada

and more 4 locations

SBRT and Durvalumab for Inoperable/Unresectable Hepatocellular Carcinoma

First Posted Date
2021-06-04
Last Posted Date
2021-06-04
Lead Sponsor
The University of Hong Kong
Target Recruit Count
37
Registration Number
NCT04913480
Locations
🇭🇰

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

© Copyright 2024. All Rights Reserved by MedPath