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

Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations

First Posted Date
2019-02-15
Last Posted Date
2024-12-09
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
108
Registration Number
NCT03842228
Locations
🇺🇸

Keck Medicine of USC Buena Park, Buena Park, California, United States

🇺🇸

Keck Medicine of USC Koreatown, Los Angeles, California, United States

🇺🇸

Los Angeles General Medical Center, Los Angeles, California, United States

and more 14 locations

M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

First Posted Date
2019-02-15
Last Posted Date
2024-01-16
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
153
Registration Number
NCT03840902
Locations
🇺🇸

University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology, Houston, Texas, United States

🇺🇸

Lynn Cancer Institute Center, Boca Raton, Florida, United States

🇺🇸

American Health Network of Indiana, LLC, Indianapolis, Indiana, United States

and more 101 locations

PD-L1 ImagiNg to prediCt Durvalumab Treatment Response in HNSCC

First Posted Date
2019-02-04
Last Posted Date
2022-01-10
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
33
Registration Number
NCT03829007
Locations
🇳🇱

UMC Groningen, Groningen, Netherlands

🇳🇱

Amsterdam UMC, Amsterdam, Netherlands

🇳🇱

Leiden UMC, Leiden, Netherlands

and more 1 locations

hARnessing CAbozantinib and Durvalumab Immuno-oncology Association: ARCADIA Study"

First Posted Date
2019-01-31
Last Posted Date
2021-02-25
Lead Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Target Recruit Count
122
Registration Number
NCT03824691
Locations
🇮🇹

Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy

Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC

First Posted Date
2019-01-30
Last Posted Date
2024-10-07
Lead Sponsor
MedImmune LLC
Target Recruit Count
189
Registration Number
NCT03822351
Locations
🇨🇳

Research Site, Taichung, Taiwan

Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer

First Posted Date
2019-01-29
Last Posted Date
2023-09-18
Lead Sponsor
The Methodist Hospital Research Institute
Target Recruit Count
39
Registration Number
NCT03820141
Locations
🇺🇸

Houston Methodist Cancer Center, Houston, Texas, United States

Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable NSCLC

First Posted Date
2019-01-28
Last Posted Date
2024-02-15
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
7
Registration Number
NCT03818776
Locations
🇺🇸

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC

First Posted Date
2019-01-28
Last Posted Date
2024-10-22
Lead Sponsor
AstraZeneca
Target Recruit Count
175
Registration Number
NCT03819465
Locations
🇹🇭

Research Site, Hat Yai, Thailand

A Study of Olaparib and Durvalumab in Prostate Cancer

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2019-01-18
Last Posted Date
2024-04-09
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
5
Registration Number
NCT03810105
Locations
🇺🇸

City of Hope Comprehensive Cancer Center, Duarte, California, United States

🇺🇸

Memorial Sloan Kettering Westchester, Harrison, New York, United States

🇺🇸

Memorial Sloan Kettering Commack, Commack, New York, United States

and more 5 locations
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